NationMaster - Encyclopedia: Thalidomide

Thalidomide is a sedative, hypnotic, and multiple myeloma medication. The drug is a potent teratogen in rats, rabbits, non-human primates and humans.[1] Thalidomide was developed by German pharmaceutical company Grünenthal. It was sold from 1957 to 1961 in almost 50 countries under at least 40 names, including Distaval, Talimol, Nibrol, Sedimide, Quietoplex, Contergan, Neurosedyn, and Softenon. Thalidomide was chiefly sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep. Before its release inadequate tests were performed to assess the drug's safety, with catastrophic results for the children of women who had taken thalidomide during their pregnancies. In pharmacology and toxicology, a route of administration is the path by which a drug, fluid, poison or other substance is brought into contact with the body. ... A sedative is a substance that depresses the central nervous system (CNS), resulting in calmness, relaxation, reduction of anxiety, sleepiness, and slowed breathing, as well as slurred speech, staggering gait, poor judgment, and slow, uncertain reflexes. ... Hypnotic drugs are a class of drugs that induce sleep, used in the treatment of severe insomnia. ... Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahlers disease after Otto Kahler) is a type of cancer of plasma cells which are immune system cells in bone marrow that produce antibodies. ... This article does not cite any references or sources. ... Teratology (from the Greek teras (genitive teratos), meaning monster, and logos meaning study) is the medical study of teratogenesis or grossly deformed individuals. ... GrÃ¼nenthal is a German pharmaceutical company. ... A pregnant woman Pregnancy is the process by which a mammalian female carries a live offspring from conception until it develops to the point where the offspring is capable of living outside the womb. ... An antiemetic is a drug that is effective against vomiting and nausea. ... Morning sickness, also called nausea and vomiting of pregnancy (NVP) or pregnancy sickness, affects between 50 and 95 percent of all pregnant women as well as some women who take birth control pills or hormone replacement therapy. ...

From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy.^[1] In 1962, in reaction to the tragedy, the United States Congress enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale in the U.S.^[2] Other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades. Phocomelia (from Greek Ï†oko = seal plus Î¼ÎÎ»Î¿Ï‚ (plural Î¼ÎÎ»ÎµÎ±) = limb) is a congenital disorder involving the limbs (dysmelia), that presents at birth very short or absent long bones and flipper-like appearance of hands and sometimes feet. ... Type Bicameral Houses Senate House of Representatives President of the Senate President pro tempore Dick Cheney, (R) since January 20, 2001 Robert C. Byrd, (D) since January 4, 2007 Speaker of the House Nancy Pelosi, (D) since January 4, 2007 Members 535 plus 4 Delegates and 1 Resident Commissioner Political...

Researchers, however, continued to work with the drug. Soon after its banishment, a doctor discovered anti-inflammatory effects of thalidomide and began to look for uses of the medication despite its teratogenic effects. They found that patients with erythema nodosum leprosum, a painful skin condition associated with leprosy, experienced relief of their pain by taking thalidomide. Further work showed that it was effective in multiple myeloma, and it is now approved by the FDA for use in this malignancy. There are studies underway to determine the drug's effects on arachnoiditis, Crohn's disease, and several types of cancers. However, physicians and patients alike must go through a special process to prescribe and receive thalidomide to ensure no more children are born with birth defects traceable to the medication. For the malady found in the Hebrew Bible, see the article Tzaraath. ... Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahlers disease after Otto Kahler) is a type of cancer of plasma cells which are immune system cells in bone marrow that produce antibodies. ... Arachnoiditis describes a pain disorder caused by the inflammation of the arachnoid, one of the membranes that surround and protect the nerves of the spinal cord. ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining between). ... Cancer is a class of diseases or disorders characterized by uncontrolled division of cells and the ability of these to spread, either by direct growth into adjacent tissue through invasion, or by implantation into distant sites by metastasis (where cancer cells are transported through the bloodstream or lymphatic system). ...

History

Discovery and introduction

A German pharmaceutical company, Chemie Grünenthal at Stolberg, synthesized thalidomide in West Germany in 1953 while searching for an inexpensive method of manufacturing antibiotics from peptides. By heating phthaloylisoglutamine, the company's chief researcher produced phthalimidoglutarimide, which they soon labeled 'thalidomide'. Chemie Grünenthal patented the molecule and began searching for a disease thalidomide could cure.^[3] GrÃ¼nenthal is a German pharmaceutical company. ... Stolberg (pronounced ) is a town in North Rhine-Westphalia, Germany. ... Peptides are the family of molecules formed from the linking, in a defined order, of various amino acids. ...

The Grünenthal scientists could not find any antibiotic activity, or any other encouraging effects, in mice and rats. However, the new chemical seemed to be harmless; high doses did not kill rodents, rabbits, cats or dogs, nor show any other side effects.^[3] The research team began to describe thalidomide as "nontoxic" and Grünenthal began to consider the lucrative prospects of their new find. Although no sedative or tranquilizing effects were observed in animals, Grünenthal management considered "a nonlethal sedative would have enormous market potential".^[3]

With no teratogenicity tests (tests on pregnant animals), no clinical trial plans, and no scientific rationale, Grünenthal began distributing free samples of thalidomide to doctors in Switzerland and West Germany in 1955. It was first recommended for the prevention of seizures in patients with epilepsy; although no anticonvulsant effect was found, patients reported experiencing a deep sleep. Other patients said they felt calming and soothing effects. Some reported side effects, but they were not believed to be serious.^[3] One author later said that "Thalidomide was introduced by the method of Russian Roulette. Practically nothing was known about the drug at the time of its marketing".^[4] This article is about the medical condition. ... Russian roulette is a lethal form of gambling in which participants place a single round in a chamber of a revolver and, spinning the cylinder such that the location of the round is unknown, take turns putting the weapon to their temples (heads) and pulling the trigger until the weapon...

Thalidomide could not be sold in West Germany until its effects on animals were documented – usually effects of a drug are demonstrated on animals before the drug is administered to humans, but thalidomide was not tested that way. The sedative effects had not been seen in animals, so the Grünenthal scientists came up with a "jiggle cage" to measure the movements of mice to see if treated mice "jiggled" the cage less than non-treated mice. Grünenthal also pointed out that their "powerful hypnotic drug was completely safe".^[3]

An employee of Chemie Grünenthal brought home samples of the new drug for his pregnant wife and ten months before thalidomide was put on the market in Germany, on Christmas Day in 1956, their child was born without ears. Years later, the father learned that his daughter was the first living victim of the epidemic of thalidomide-induced infant malformations and deaths.^[3] Joseph and Mary with baby Jesus, at the first Christmas Christmas (literally, the Mass of Christ) is a holiday in the Christian calendar, usually observed on December 25, which celebrates the birth of Jesus. ...

The company began selling the drug over the counter in Germany in October 1957, under the brand name Contergan. The company claimed that "Even a determined suicide could not take enough Contergan to cause death" and "accidental overdoses by children would be unheard of with this drug". Not one of those statements turned out to be true. Soon the drug was being sold in 46 countries under "at least 37 names",^[3] without any additional independent testing, and was the drug of choice for pregnant women with morning sickness.^[5]

Frances Kelsey

By 1960, Grünenthal was selling thalidomide tablets all over the world – except in the United States. A Cincinnati, Ohio company called Richardson-Merrell tried to change that in September 1960, when it applied for Food and Drug Administration (FDA) approval to sell thalidomide in the United States under the brand name of Kevadon. The company wanted to begin sales of Kevadon in early 1961. This approval was not expected to be controversial, and the case was given to the agency's newest reviewer, Frances Oldham Kelsey, who had joined the FDA only one month before. â€œCincinnatiâ€ redirects here. ... â€œFDAâ€ redirects here. ... Frances Oldham Kelsey (24 June 1914-) is a naturalized American pharmacologist most famous as a reviewer for the US Food and Drug Administration who refused to authorize thalidomide for market when she had serious concerns about the drugs safety. ...

At the time, the prevailing US law was the 1938 Federal Food, Drug, and Cosmetic Act, which required proof of safety be sent to the FDA before a medication could be approved for sale in the United States. The law did not require demonstration of efficacy for approval. It also allowed "investigational" or "experimental" use of a drug while approval for its sale was being sought, meaning that a medication could be widely distributed before it was approved.^[6] The law gave the FDA 60 days to review a drug application. If the FDA reviewer told a drug company that its application for a particular medication was incomplete, it was considered withdrawn and the company would have to submit more data when it resubmitted the application. With each resubmission, the 60 days started all over again.^[1] The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ...

This was Kelsey's first drug review assignment for the FDA. She was interested in fetal safety because in the 1940s she had studied quinine, including its effects in pregnancy, while she was part of a team that was trying to find a synthetic cure for malaria. In particular, she recalled a study she conducted on rabbits at the University of Chicago. In that study, she noted that adult rabbits metabolized quinine rapidly, but pregnant rabbits were less able to metabolize it and embryonic rabbits could not metabolize it at all. Contrary to the prevailing theories of the time, Kelsey found that the drug passed through the placental barrier between mother and fetus.^[5] Recalling her work with quinine, Kelsey thought that perhaps thalidomide acted the same way – if so, thalidomide might be safe for older, non-pregnant patients, but could be toxic to children, pregnant women and their fetuses. Quinine (IPA: ) is a natural white crystalline alkaloid having antipyretic (fever-reducing), antimalarial, analgesic (painkilling), and anti-inflammatory properties and a bitter taste. ... Malaria is a vector-borne infectious disease caused by protozoan parasites. ... For other uses, see Rabbit (disambiguation). ... The University of Chicago is a private university located principally in the Hyde Park neighborhood of Chicago. ... The placenta is an ephemeral (temporary) organ present only in female placental mammals during gestation (pregnancy). ...

In addition to the lack of teratogenicity data, Kelsey had other worries about thalidomide as well. It was not enough to know how the drug acted in animals – she wanted to know how it worked in humans. She wanted to know about the drug's mechanism of action – its effects on human metabolism, its chemistry and pharmacology and its stability.^[2] However, none of this data had been provided by Richardson-Merrell. There had been no chronic toxicity studies, excretion and absorption data was inadequate and there were few manufacturing controls in place to assure quality.

Kelsey rejected the application and requested the aforementioned data from the company in a letter. Richardson-Merrell resubmitted the application but with no new information and Kelsey turned it down again. She continued to request more data from the company and with each request the 60 day clock was rewound to its beginning. As the end of 1960 approached and with it the holiday season (the best time for selling sedatives),^[3] Richardson-Merrell began ratcheting up the pressure on the FDA and Kelsey. Executives and scientists telephoned and personally visited Kelsey, and executives complained to her superiors that she was nit-picking and unreasonable.^[1]^[5]

Still, Kelsey refused to clear Kevadon for sale in the United States until she could review satisfactory studies. She later said that the reports submitted by Grünenthal and Richardson-Merrell were more like testimonials than results of well-designed, controlled studies.^[1] (One possible reason for the lack of data could be that Richardson-Merrell's "investigation" of thalidomide for its FDA application was organized and implemented not by scientists, but by the company's sales and marketing division.)^[3] Kelsey had also heard anecdotal reports of peripheral neuropathy as a side effect of thalidomide, which only made her think more about the possible effects on a fetus. She continued to reject the Kevadon application. In total, the company resubmitted its Kevadon application to the FDA six times, but no new evidence was given in those applications and Kelsey refused to budge. Peripheral neuropathy is the term for damage to nerves of the peripheral nervous system, which may be caused either by diseases of the nerve or from the side-effects of systemic illness. ...

Side Effects: Birth Defects

Unusual side effects had been reported by patients taking thalidomide in the UK, including peripheral neuropathy. Worse, pregnant women who had taken the drug were giving birth to babies with a condition called phocomelia – abnormally short limbs with toes sprouting from the hips and flipper-like arms. Other infants had eye and ear defects or malformed internal organs such as unsegmented small or large intestines. Chemie Grünenthal denied that thalidomide was responsible for any of these problems. In 1959, Grünenthal responded to one doctor's inquiry by saying, "We have no idea how these cases... could have been caused by Contergan".^[3] Image File history File links Metadata Size of this preview: 388 Ã— 599 pixelsFull resolution (1749 Ã— 2700 pixel, file size: 1. ... Image File history File links Metadata Size of this preview: 388 Ã— 599 pixelsFull resolution (1749 Ã— 2700 pixel, file size: 1. ... Phocomelia (from Greek Ï†oko = seal plus Î¼ÎÎ»Î¿Ï‚ (plural Î¼ÎÎ»ÎµÎ±) = limb) is a congenital disorder involving the limbs (dysmelia), that presents at birth very short or absent long bones and flipper-like appearance of hands and sometimes feet. ... In biology the small intestine is the part of the gastrointestinal tract (gut) between the stomach and the large intestine and includes the duodenum, jejunum, and ileum. ... The large intestine, or the organ which is now more commonly referred to by its Greek name, the colon, is the last part of the digestive system: the final stage of the alimentary canal in vertebrate animals. ...

Under US law at the time, Richardson-Merrell had been legally distributing Kevadon on an "investigational" basis since early 1960 and pregnant women were included as patients after the first three months of the trial. American doctors were told,^[3]

In December 1960, three months after Richardson-Merrell applied for FDA approval of Kevadon, the British Medical Journal published a letter from a British physician who reported cases of peripheral neuropathy, or painful extremities, in patients who had taken thalidomide over a long period of time. Kelsey read this letter, and she believed it was the first indication of toxicity effects.^[5] It increased her misgivings about approving the application, and she immediately requested information from Richardson-Merrell about the problem. The company denied knowing about any harmful side effects. Years later, it was shown that Richardson-Merrell knew about the risk of nerve damage but failed to disclose the fact to the FDA.^[3] Throughout 1961, more unofficial, anecdotal reports of thalidomide side effects surfaced in Europe and Australia. The British Medical Journal (BMJ) is a medical journal published weekly in the United Kingdom by the British Medical Association (BMA)which published its first issue in 1845. ...

On November 18, 1961, the German paper Welt am Sonntag published a letter by German pediatrician Widukind Lenz.^[6] Lenz described more than 150 infants with malformations, including phocomelia, and associated them with thalidomide given to their mothers.^[3] A stunning statistic was that 50 percent of the mothers with deformed children had taken thalidomide during the first trimester of pregnancy.^[1] The limits of danger were amazingly narrow: women who took even one tablet of thalidomide between the 20th and 36th day after conception were at risk for delivering malformed infants – beyond that time, the drug caused no deformities at all.^[3] Lenz notified Chemie Grünenthal about the dangers of its flagship product; ten days later, German authorities removed thalidomide from the market against Grünenthal's wishes. Grünenthal withdrew thalidomide soon afterward from the market and notified Richardson-Merrell of its decision. is the 322nd day of the year (323rd in leap years) in the Gregorian calendar. ... Year 1961 (MCMLXI) was a common year starting on Sunday (link will display full calendar) of the Gregorian calendar. ... Welt am Sonntag (World on Sunday) is a national German national Sunday newspaper published by Axel Springer AG, and established in 1948. ... Pediatrics (also spelled paediatrics or pædiatrics) is the branch of medicine that deals with the medical care of infants and children. ...

In December, The Lancet, one of the oldest peer-reviewed medical journals in the world, published a letter by William McBride, an Australian physician, who noted large numbers of birth defects in the children of women who had taken thalidomide.^[7] Other countries quickly pulled the drug from their stores and pharmacies. However, Grünenthal continued to dispute the claims that thalidomide was responsible for the defects, saying that their action was "merely a response to the sensationalism".^[3] The Lancet is one of the oldest and most respected peer-reviewed medical journals in the world, published weekly by Elsevier, part of Reed Elsevier. ... Dr. William McBride, gynaecologist and obstetrictrician, is the Australian doctor who discovered the teratogenicity of thalidomide which ended the practice of prescribing it during pregnancy. ...

Richardson-Merrill withdrew its Kevadon application in March 1962, but the sheer number and variety of brand names meant the drug remained available in some countries – thalidomide could be found in Brazil, Italy, and Japan as long as nine months after the German withdrawal.^[8]

Unfortunately, Grünenthal's decision was too late for thousands of families. An estimated 8,000 to 12,000 infants were born with deformities caused by thalidomide, and of those only about 5,000 survived beyond childhood.^[3] The medication never received approval for sale in the United States, but 2.5 million tablets had been given to more than 1,200 American doctors during Richardson-Merrell's "investigation" and nearly 20,000 patients received thalidomide tablets, including several hundred pregnant women. In the end, 17 American children were born with thalidomide-related deformities.^[1] An estimated 40,000 people developed drug-induced peripheral neuropathy. Exact numbers will never be known because the companies and doctors kept incomplete and inaccurate records. Fortunately, no thalidomide victims have passed defects to their children, because thalidomide is not a mutagen.^[9] In biology, a mutagen (Latin, literally origin of change) is a physical or chemical agent that changes the genetic information (usually DNA) of an organism and thus increases the number of mutations above the natural background level. ...

The ensuing American media coverage of thalidomide children and the woman who refused to approve the drug for use in the United States, enveloped Kelsey and the FDA. Kelsey was praised in a story by Morton Mintz in The Washington Post on July 15, 1962. The headline read, " 'Heroine' of FDA Keeps Bad Drug Off of Market". Follow-up articles appeared in The New York Times, Life magazine, Saturday Review and hundreds of other publications of the day. Morton Mintz is a renowned investigative journalist who in his early years (1946-1958) reported for two St. ... The Washington Post is the largest newspaper in Washington, D.C.. It is also one of the citys oldest papers, having been founded in 1877. ... is the 196th day of the year (197th in leap years) in the Gregorian calendar. ... Year 1962 (MCMLXII) was a common year starting on Monday (the link is to a full 1962 calendar) of the Gregorian calendar. ... The New York Times is a daily newspaper published in New York City and distributed internationally. ... A cover of Life Magazine from 1911 Life has been the name of two notable magazines published in the United States. ... Saturday Review is a UK publication for which Winston Churchill reported. ...

More importantly, a controversial bill by U.S. Senator Estes Kefauver, of Tennessee, was resurrected and rewritten, passed by Congress, and signed by President John F. Kennedy on October 10, 1962. The Kefauver Harris Amendment strengthened the FDA's control of experimentation on humans and changed the way new drugs were approved and regulated. Before the thalidomide scandal, U.S. drug companies only had to show their new products were safe; for the first time, they would have to show their new drugs were safe and effective.^[6] Informed consent was required of patients participating in clinical trials and adverse drug reactions were required to be reported to the FDA. The United States Senate is the upper house of the U.S. Congress, smaller than the United States House of Representatives. ... The issue of Time Magazine in which Kefauvers victory in the New Hampshire primary was reported. ... Official language(s) English Capital Nashville Largest city Memphis Largest metro area Nashville Metropolitan Area Area Ranked 36th - Total 42,169 sq mi (109,247 kmÂ²) - Width 120 miles (195 km) - Length 440 miles (710 km) - % water 2. ... John Kennedy and JFK redirect here. ... is the 283rd day of the year (284th in leap years) in the Gregorian calendar. ... Year 1962 (MCMLXII) was a common year starting on Monday (the link is to a full 1962 calendar) of the Gregorian calendar. ... The U.S. Kefauver Harris Amendment or Drug Efficacy Amendment of 1962 was a response to the Thalidomide tragedy in Europe. ... Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. ...

The legal mess caused by the effects of thalidomide and Chemie Grünenthal's shoddy testing and approval procedures, is still winding its way through courts worldwide even 50 years later. In connection with one of the first lawsuits, a court-ordered gag rule prohibited all mention of the thalidomide effects for ten years, from 1962 to 1972.^[3] In one of the more recent developments in 2003, the Swedish government authorized an ex gratia compensation of SEK 250,000 for each of the 150 individuals that were subjected to thalidomide (marked in Sweden as Neurosedyn). According to a widely disputed investigation by the Swedish Office of the Chancellor of Justice (Justitiekanslern), no blame falls on the Swedish government. The Swedish government later decided to raise the compensation to SEK 500,000 each.^{[citation needed]} A gag rule is a rule that limits or forbids the consideration or discussion of a topic. ... The government of Sweden is a constitutional monarchy based on parliamentary democracy. ... Ex gratia (sometimes ex-gratia) is Latin (lit. ... ISO 4217 Code SEK User(s) Sweden Inflation 2. ... In some countries, the Chancellor of Justice is a government official responsible for supervising the lawfulness of government actions. ...

Thalidomide today

FDA Approval

"On May 26, 2006, the U.S. Food and Drug Administration granted accelerated approval for thalidomide (Thalomid, Celgene Corporation) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma (MM) patients." [2] The FDA approval came seven years after the first reports of efficacy in the medical literature (Desikan R, Munshi N, Zeldis J, et al. Activity of thalidomide (THAL) in multiple myeloma (MM) confirmed in 180 patients with advanced disease. Blood 1999;94:Suppl 1:603a-603a.abstract), and Celgene took advantage of "off-label" marketing opportunities to promote the drug in advance of its FDA approval for the myeloma indication. Thalomid, as the drug is commercially known, sold over $300 million per year, while only approved for leprosy. [3] Thalidomide was and still is (2006) an important advance in the treatment of multiple myeloma, ever since news of its efficacy spread throughout the medical literature in 2000. ^{[citation needed]} The drug has some bothersome nuisance side effects such as neuropathy, constipation and fatigue, but is likely more effective than standard chemotherapy for multiple myeloma. Thalidomide, along with another new drug, bortezomib, is changing the landscape of multiple myeloma treatment, such that toxic stem cell transplants may no longer be the standard treatment for this incurable malignancy. Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahlers disease after Otto Kahler) is a type of cancer of plasma cells which are immune system cells in bone marrow that produce antibodies. ... Bortezomib (VelcadeTM) is a first-in-class proteasome inhibitor. ...

Possible indications

Research on thalidomide slowed in the 1960s, but never completely stopped. There is at least one university in the United States that pursues thalidomide research, even though it is only one tenured professor. The medication is now an example of how potentially dangerous chemical compounds can be used therapeutically with appropriate precautions and procedures.

In 1964, an Israeli physician named Jacob Sheskin was trying to help a critically-ill French patient with erythema nodosum leprosum(ENL), a very painful complication of leprosy. He looked throughout his small hospital for anything that might help his patient stop aching long enough to sleep. He came across a bottle of thalidomide tablets, and remembered that the drug had been effective in helping mentally ill patients sleep – and also that it was banned. Thinking he had nothing to lose, Sheskin gave the man two tablets of thalidomide. The patient slept for hours, and he felt good enough to get out of bed without aid when he woke up. The result was soon followed by more favorable experiences, followed by a clinical trial. Dr. Sheskin's drug of last resort revolutionized the care of leprosy, and led to the closing of most leprosy hospitals.^[3] For the malady found in the Hebrew Bible, see the article Tzaraath. ...

Serious infections including sepsis and tuberculosis cause the level of Tumor necrosis factor-alpha (TNFα) to rise. TNFα is a chemical mediator in the body, and it may enhance the wasting process in cancer patients as well. Thalidomide may reduce the levels of TNFα, and it is possible that the drug's effect on ENL is caused by this mechanism.^[2] Sepsis (in Greek Î£Î®ÏˆÎ¹Ï‚, putrefaction) is a serious medical condition, resulting from the immune response to a severe infection. ... Tuberculosis (abbreviated as TB for tubercle bacillus or Tuberculosis) is a common and deadly infectious disease caused by mycobacteria, mainly Mycobacterium tuberculosis. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ...

Thalidomide also has potent anti-inflammatory effects that may help ENL patients. In July 1998, the FDA approved the application of Celgene to distribute thalidomide under the brand name Thalomid for treatment of ENL. Pharmion Corporation, who licensed the rights to market Thalidomide in Europe, Australia and various other territories from Celgene, received approval for its use against multiple myeloma in Australia and New Zealand in 2003.^[6] Thalomid, in conjunction with dexamethasone, is now standard therapy for multiple myeloma. Celgene Corporation NASDAQ: CELG is a manufacturer of drug therapies for cancer and inflammatory disorders. ... Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahlers disease after Otto Kahler) is a type of cancer of plasma cells which are immune system cells in bone marrow that produce antibodies. ... Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid hormones. ...

Thalidomide also inhibits the growth of new blood vessels (angiogenesis), which may be useful in treating macular degeneration and other diseases; this effect also helps AIDS patients with Kaposi's sarcoma, although there are better and cheaper drugs to treat the condition. Also for AIDS patients, thalidomide may be able to fight painful, debilitating aphthous lesions in the mouth and esophagus which prevent sufferers from eating. The FDA formed a Thalidomide Working Group in 1994 to provide consistency between its divisions, with particular emphasis on safety monitoring. The agency also imposed severe restrictions on the distribution of Thalomid through the System for Thalidomide Education and Prescribing Safety (STEPS) program.^[2] Angiogenesis is the physiological process involving the growth of new blood vessels from pre-existing vessels. ... Listen to this article ( info) in media player in browser This audio file was created from an article revision dated 2005-07-19, and may not reflect subsequent edits to the article. ... For other uses, see AIDS (disambiguation). ...

Thalidomide is also being investigated for treating symptoms of prostate cancer, glioblastoma, lymphoma, arachnoiditis, Behçet's disease, and Crohn's disease. In a small trial, Australian researchers found thalidomide sparked a doubling of the number of T cells in patients, allowing the patients' own immune system to attack cancer cells. ^{[citation needed]} Prostate cancer is a disease in which cancer develops in the prostate, a gland in the male reproductive system. ... A glioma is a type of primary central nervous system (CNS) tumor that arises from glial cells. ... This article is about lymphoma in humans. ... Arachnoiditis describes a pain disorder caused by the inflammation of the arachnoid, one of the membranes that surround and protect the nerves of the spinal cord. ... BehÃ§et disease (BehÃ§ets syndrome, Morbus BehÃ§et, silk road disease) is a chronic condition due to disturbances in the bodyâ€™s immune system. ... T cells are a subset of lymphocytes that play a large role in the immune response. ... A scanning electron microscope image of a single neutrophil (yellow), engulfing anthrax bacteria (orange). ...

On October 5, 2007, Thierry Facon, specialist in blood diseases at Lille University, France who led a research, stated that: "The main message is the addition of thalidomide is able to improve survival. Elderly patients with an aggressive form of blood cancer lived about 20 months longer when given the drug thalidomide as part of their treatment." The drug also slowed the spread of myeloma and had also been approved to treat leprosy.^[10] For other uses, see 5th October (Serbia). ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... Multiple myeloma (also known simply as myeloma or plasma cell myeloma) is a hematological malignancy of plasma cells, the cells of the immune system that produce antibodies. ... For the malady found in the Hebrew Bible, see the article Tzaraath. ...

Teratogenic mechanism

Thalidomide is racemic – it contains both left- and right-handed isomers in equal amounts. One enantiomer is effective against morning sickness. The other is teratogenic and causes birth defects. The enantiomers can interconvert in vivo – that is, if a human is given pure (R)-thalidomide or (S)-thalidomide, both isomers can be found in the serum – therefore, administering only one enantiomer will not prevent the teratogenic effect in humans. The mechanism is being debated, with current literature that suggests that it intercalates into the DNA in G-C rich regions. Image File history File links Download high-resolution version (1100x594, 139 KB) File links The following pages on the English Wikipedia link to this file (pages on other projects are not listed): Thalidomide ... Image File history File links Download high-resolution version (1100x594, 139 KB) File links The following pages on the English Wikipedia link to this file (pages on other projects are not listed): Thalidomide ... In chemistry, a racemate is a mixture of equal amounts of left- and right-handed stereoisomers of a chiral molecule. ... In chemistry, isomers are molecules with the same chemical formula and often with the same kinds of chemical bonds between atoms, but in which the atoms are arranged differently (analogous to a chemical anagram). ... Optical isomerism is a form of isomerism (specifically stereoisomerism) where the two different isomers are the same in every way except being non-superposable mirror images of each other. ... Teratology (from the Greek teras (genitive teratos), meaning monster, and logos meaning study) is the medical study of teratogenesis or grossly deformed individuals. ... In vivo (Latin for (with)in the living). ... Blood plasma is the liquid component of blood, in which the blood cells are suspended. ... Intercalation induces structural distortions. ...

Side effects

Apart from its infamous tendency to induce birth defects and peripheral neuropathy, the main side effects of thalidomide include fatigue and constipation. It also is associated with an increased risk of deep vein thrombosis especially when combined with dexamethasone, as it is for treatment of multiple myeloma. High doses can lead to pulmonary edema, atelectasis, aspiration pneumonia and refractory hypotension. Constipation or irregularity, is a condition of the digestive system where a person (or animal) experiences hard feces that are difficult to egest; it may be extremely painful, and in severe cases (fecal impaction) lead to symptoms of bowel obstruction. ... This article is about Deep-vein thrombosis. ... Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid hormones. ... Pulmonary edema is swelling and/or fluid accumulation in the lungs. ... Atelectasis is defined as a state in which the lung, in whole or in part, is collapsed or without air. ... Aspiration pneumonia is a specific form of lung infection (pneumonia) that develops when oral or gastric contents (including food, saliva, or nasal secretions) enter the bronchial tree. ... In physiology and medicine, hypotension refers to an abnormally low blood pressure. ...

Thalidomide analogs

The exploration of the antiangiogenic and immunomodulatory activities of thalidomide has led to the study and creation of thalidomide analogs. In 2005, Celgene received FDA approval for lenalidomide (Revlimid) as the first commercially useful derivative. Revlimid is only available in a restricted distribution setting to avoid its use during pregnancy. Further studies are conducted to find safer compounds with useful qualities. Another analog, Actimid (CC-4047), is in the clinical trial phase.[4] These thalidomide analogs can be used to treat different diseases, or used in a regimen to fight two conditions. Antiangiogenic refers to a chemical or biological agent that inhibits or greatly reduces formation of new blood vessels (angiogenesis). ... An analog is in chemistry a chemical closely related to another usually sharing the same nucleus. ... Lenalidomide (initially known as CC-5013 and marketed as RevlimidÂ® by Celgene) is a derivative of thalidomide introduced in 2004. ...

Notable children of those who took thalidomide

Image File history File links Broom_icon. ... Human rights are rights which some hold to be inalienable and belonging to all humans. ... Thalidomide!! stars Mat Fraser and Anna Winslet. ... Alvin Law, CSP (born 1960 in Yorkton, Saskatchewan) is a motivational speaker and former radio broadcaster. ... Tony Melendez is a Nicaraguan guitar player, singer and Christian rock songwriter who was born without arms. ... The German bass-baritone Thomas Quasthoff (born November 9, 1959) is generally regarded as one of the finest lieder singers of his generation. ... Terry (Terrence) Wiles was born in Peterborough, Cambridgeshire in the UK on January 12 1962. ...

Thalidomide in literature, music & arts

Marjorie Shiona Wallace MBE, (Countess Skarbek), born 1944 in Nairobi, Kenya, Wallace is an award winning writer, broadcaster and investigative journalist [1] and is the chief executive of SANE,a mental health charity in the UK established in 1986. ... Terry (Terrence) Wiles was born in Peterborough, Cambridgeshire in the UK on January 12 1962. ... Peter Milligan is an Irish writer, best known for his comic book, film and television work. ... Brendan McCarthy is a British artist and designer best known for his work in comic books, film and television. ... Trade paperback of Will Eisners A Contract with God (1978), often mistakenly cited as the first graphic novel. ... Skin is a short (48 pages) graphic novel written by Peter Milligan and drawn by Brendan McCarthy with colors by Carol Swain. ... Skinheads, named for their close-cropped or shaven heads, are a working-class subculture that originated in the United Kingdom in the late 1960s, and then spread to other parts of the world. ... Martin Luther King, Jr. ... DVD cover showing horror characters as depicted by Universal Studios. ... Scanners is a 1981 action / science fiction / horror film written and directed by David Cronenberg. ... Punk rock is an anti-establishment music movement beginning around 1976 (although precursors can be found several years earlier), exemplified and popularised by The Ramones, the Sex Pistols, The Clash and The Damned. ... NOFX is an American punk rock band formed in Los Angeles, California, in 1983. ... We Didnt Start the Fire is a song by Billy Joel that chronicles 120 well-known events, people, things, and places widely noted during his lifetime, from March 1949 to 1989, when the song was released on his album Storm Front. ... William Martin Billy Joel (born May 9, 1949) is an American singer, pianist, songwriter, composer and musician. ... Science Fiction book by Douglas Preston. ... Douglas Preston (born 1956 in Cambridge, Massachusetts) is an author of several techno-thriller and horror novels with Lincoln Child. ... Lincoln Child (born 1957) is an author of techno-thriller and horror novels. ... Sylvia Plath (October 27, 1932 â€“ February 11, 1963) was an American poet, novelist, and short story writer. ... Douglas Coupland (born December 30, 1961) is a major Canadian fiction writer as well as a playwright and visual artist. ... Irvine Welsh (born Leith, Edinburgh, September 27, 1958) is an acclaimed contemporary Scottish novelist, most famous for his novel Trainspotting. ... Slipknot (sometimes typeset as SlipKnoT to fit their logo) is a Grammy winning American metal band from Des Moines, Iowa. ... Amateur Transplants is a band comprising two medical doctors, Dr. Adam Kay and Dr. Suman Biswas although it is rumoured they have split up due to artistic differences[citation needed]. Their album Fitness to Practice contains comic songs dealing with medical subjects as well as containing the infamous London Underground... Geek Love is a novel by Katherine Dunn and first published in 1983. ... Katherine Dunn is a novelist, journalist, book reviewer, and poet from Portland, Oregon. ... Philip Kindred Dick (December 16, 1928 â€“ March 2, 1982) was an American writer, mostly known for his works of science fiction. ... Harvie Krumpet is an Australian claymation, made in St Kilda, Melbourne by Adam Elliot (Melodrama Pictures). ...

References

^ ^a ^b ^c ^d ^e ^f Bren, Linda. "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History", FDA Consumer, US Food and Drug Administration, 2001-02-28. Retrieved on 2006-09-21.
^ ^a ^b ^c ^d Burkholz, Herbert. "Giving Thalidomide a Second Chance", FDA Consumer, US Food and Drug Administration, 1997-09-01. Retrieved on 2006-09-21.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l ^m ⁿ ^o ^p ^q ^r Silverman, MD, William (2002-04-22). "The Schizophrenic Career of a "Monster Drug"". Pediatrics 110 (2): 404-406. Retrieved on 2006-09-21.
^ Sjostrom, Henning; Nilsson, Robert (1972). Thalidomide and the power of the drug companies. Hammondsworth: Penguin. ISBN 0-14-052298-0.
^ ^a ^b ^c ^d Karen Geraghty (July 2006). Profile of a Role Model. AMA (Virtual Mentor). American Medical Association. Retrieved on 2006-09-21.
^ ^a ^b ^c ^d Rouhi, Maureen. Thalidomide. Chemical & Engineering News. American Chemical Society. Retrieved on 2006-09-21.
^ Thalidomide and congenital abnormalities. The Lancet. James Lind Library (December 1961). Retrieved on 2006-09-21.
^ Lenz, Widukind. The History of Thalidomide. 1992 UNITH Congress address. Thalidomide Victims Association of Canada. Retrieved on 2006-09-21.
^ Smithells, Dick (Nov 1998). "Does Thalidomide Cause Second Generation Birth Defects?". Drug Safety 19 (5): 339-341. Retrieved on 2006-09-21.
^ Reuters, Thalidomide helps elderly cancer patients: study

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Further reading

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External links

im studying this object for school For a list of immunosuppressive drugs, see the transplant rejection page. ... A section of the Anatomical Therapeutic Chemical Classification System. ... // Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell and are all clones of a single parent cell. ... Tumor necrosis factor (TNF) promotes the inflammatory response, which in turn causes many of the clinical problems associated with autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis, Crohns disease, psoriasis and refractory asthma. ... Infliximab (brand name RemicadeÂ®) is a drug used to treat auto-immune disorders. ... Adalimumab (HumiraÂ®) is the third TNF antagonist (after infliximab and etanercept) to be approved in the US. Like infliximab and etanercept, adalimumab binds to TNFÎ±, preventing it from activating TNF receptors; adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept... The introduction to this article provides insufficient context for those unfamiliar with the subject matter. ... Afelimomab (also known as Fab 2) is a anti-TNF-Î± monoclonal antibody. ... Anrulizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat asthma. ... Aselizumab is an immunosuppressive drug. ... Atlizumab is a humanized monoclonal antibody and which its used as an immunosuppressive drug. ... Atorolimumab is an immunosuppressive drug. ... Azulizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat Type 1 diabetes. ... Balizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug to treat HIV/AIDS. Categories: | | ... Basiliximab (Simulect) is a chimeric mouse-human monoclonal antibody to the IL-2RÎ± receptor of T cells. ... Belimumab (marketed under the trade name LymphoStat-B), is a human monoclonal antibody which its used to inhibit TNFÎ±. Categories: | ... Belizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug to treat HIV/AIDS. Categories: | | ... Bertilimumab is a human monoclonal antibody and which its used to treat severe allergic disorders. ... Cedelizumab is an immunosuppressive drug. ... Citilimumab is an immunosuppressive drug. ... Clenoliximab is an immunosuppressive drug. ... Daclizumab (Zenapax) is a murine-human chimaerised monoclonal antibody to the IL-2Rα receptor of T cells. ... Destilimumab is a human monoclonal antibody and which it is used as an immunosuppressive drug. ... Doraglizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat Type 1 diabetes. ... Dorlimomab aritox is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Dorlixizumab is a chimeric/humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Dorlizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat Type 1 diabetes. ... Drinalizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat Type 1 diabetes. ... Durlizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat Type 1 diabetes. ... Eculizumab is a monoclonal antibody directed against the complement protein C5. ... Efalizumab (RaptivaÂ®, Genentech) is a medication used to treat psoriasis. ... Elsilimomab is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Erlizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Faralimomab is a mouse monoclonal antibody which its an immunosuppressive drug. ... Fontolizumab (marketed under the trade name HuZAFâ„¢) is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Galiximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... This article does not cite any references or sources. ... Gavilimomab is a mouse monoclonal antibody (also known as ABX-CBL) is an immunosuppresive drug. ... Golimumab is a human monoclonal antibody which its used as an immunosuppressive drug. ... Gomiliximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... Hylizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... This article does not cite any references or sources. ... Inolimomab is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Ipilimumab (also known as MDX-010) is a human monoclonal antibody being developed by Bristol-Myers Squibb and Medarex. ... Keliximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... Lebrilizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat asthma. ... Lerdelimumab is a human monoclonal antibody which its used as an immunosuppressive drug. ... Lucalizumab is a humanized monoclonal antibody which it is used as an immunosuppressive drug. ... Lumiliximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... Maslimomab is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Mepolizumab is a humanized monoclonal antibody and which its used an immunosuppressive drug. ... Metelimumab is a human monoclonal antibody which its used as an immunosuppressive drug. ... Morolimumab is an immunosuppresive drug. ... Muromonab-CD3 (generic name) is a monoclonal antibody (mAb), also known as Orthoclone OKT3 (Brand name). ... Natalizumab is a drug co-marketed by Biogen Idec and Ã‰lan as Tysabri. ... Nerelimomab is a mouse monoclonal antibody and which its used as an immunosuppressive drug. ... Ocrelizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Odulimomab is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Omalizumab (marketed under the name XolairÂ®) is a monoclonal antibody made by Genentech / Novartis and used mainly in allergy-related asthma therapy, with the purpose of reducing allergic hypersensitivity. ... Oteliximab is a chimeric monoclonal antibody and which it is used as an immunosuppressive drug. ... Otelixizumab is a chimeric/humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Pascolizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Pexelizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Reslizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Rovelizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Ruplizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Siplizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Talizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Teglizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Telimomab aritox is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Teneliximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... This article does not cite any references or sources. ... Tilolizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Tocilizumab (marketed under the trade name Actemraâ„¢) is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Toralizumab is a humanized monoclonal antibody which its used as an immunosuppressive drug. ... Tralizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Treglizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Trelizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Trilizumab is a humanized monoclonal antibody which is used as an immunosuppresive drug. ... Ubrelizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug and it is used to treat severe asthma. ... Vapaliximab is a chimeric monoclonal antibody which its used as an immunosuppressive drug. ... Vepalimomab is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Visilizumab (marketed under the trade name NuvionÂ® by PDL BioPharma Inc. ... Xalizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Zanolimumab (marketed under the trade name HuMax-CD4) is a human monoclonal antibody which its used as an immunosuppressive drug. ... Ziralimumab is a human monoclonal antibody which its used as an immunosuppressive drug. ... Zolimomab aritox is a mouse monoclonal antibody which its used as an immunosuppressive drug. ... Zulizumab is a humanized monoclonal antibody which it is used as an immunosuppresive drug. ... Everolimus is a new mTOR inhibitor drug used as an immunosuppressant to prevent rejection of organ transplants. ... // Chemical Designation Common references are: (+-)-15-Deoxyspergualin, 1-Amino-19-guanidino-11-hydroxy-4,9,12-triazanonadecane-10,13-dione, 15-Deoxyspergualin, 15-Deoxyspergualin Hydrochloride, 7-{(Aminoiminomethyl)amino]-N-[2-[[4-[(3-aminopropyl)amino]butyl]amino]-1-hydroxy-2-oxoethyl]heptanamide, Gusperimus (Trihydrochloride), N-[[[4-[(3-Aminopropyl)amino]-butyl]carbamoyl... Pimecrolimus is an immunomodulating agent used in the treatment of atopic dermatitis. ... Sirolimus is a relatively new immunosuppressant drug used to prevent rejection in organ transplantation, and is especially useful in kidney transplants. ... Tacrolimus (also FK-506 or Fujimycin) is an immunosuppressive drug whose main use is after allogenic organ transplant to reduce the activity of the patients immune system and so the risk of organ rejection. ... A fusion protein is a protein created through genetic engineering from two or more proteins/peptides. ... Abatacept (Orencia) is a first-generation hybrid protein composed of an immunoglobulin and CTLA-4, which is a molecule crucial for T-cell costimulation. ... Alefacept is a genetically engineered immunosuppressive drug sold under the brand name Amevive in Canada and the United States. ... Belatacept is a hybrid protein composed of an immunoglobulin, and CTLA 4, which is a molecule crucial for T-cell costimulation, selectively blocking the process of T-cell activation. ... Tumor necrosis factor (TNF) promotes the inflammatory response, which in turn causes many of the clinical problems associated with autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis, Crohns disease, psoriasis and refractory asthma. ... Etanercept (EnbrelÂ®, co-marketed by Amgen and Wyeth) is a human recombinant, soluble tumor necrosis factor-alpha (TNFÎ±) receptor. ... // Basic chemical, pharmacological and marketing data Anakinra is an IL-1 receptor antagonist. ... Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation, autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease such as Crohns disease. ... Ciclosporin (INN), cyclosporine or cyclosporin (former BAN), is an immunosuppressant drug. ... // Basic Chemical, Pharmacological, and Marketing Data Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD class of drugs, which are chemically and pharmacologically very heterogen. ... Amethopterin redirects here. ... Mycophenolic acid (INN) (IPA: ) or mycophenolate is an immunosuppressant drug used to prevent rejection in organ transplantation. ...

Contents

History

Discovery and introduction

Frances Kelsey

Side Effects: Birth Defects

Thalidomide today

FDA Approval

Possible indications

Teratogenic mechanism

Side effects

Thalidomide analogs

Notable children of those who took thalidomide

Thalidomide in literature, music & arts

References

See also

Further reading

External links

Contents

History GA_googleFillSlot("encyclopedia_square");

Discovery and introduction

Frances Kelsey

Side Effects: Birth Defects

Thalidomide today

FDA Approval

Possible indications

Teratogenic mechanism

Side effects

Thalidomide analogs

Notable children of those who took thalidomide

Thalidomide in literature, music & arts

References

See also

Further reading

External links

History