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Thalidomide Birth Defect

Thalidomide Birth Defect


Thalidomide is used as a first-line treatment in multiple myeloma in combination with dexamethasone or with melphalan and prednisone, to treat acute episodes of erythema nodosum leprosum, and for maintenance therapy.Thalidomide is used off-label in several ways.

The bacterium that causes tuberculosis is related to leprosy. Thalidomide may be helpful in some cases where standard TB drugs and corticosteroids are not sufficient to resolve severe inflammation in the brain.

It is used as a second-line treatment to manage graft versus host disease and aphthous stomatitis in children and has been prescribed for other conditions in children including actinic prurigo and epidermolysis bullosa; the evidence for these uses is weak.[11] It is recommended only as a third line treatment in graft versus host disease in adults, based on lack of efficacy and side effects observed in clinical trials.

The morning sickness drug was sold as Tensival and Distaval in West Germany. Now it is used to treat leprosy and some cancers under tightly controlled conditions

Still, the drug's US manufacturer, Richardson-Merrell, managed to push samples past Kelsey's regulatory blockade to the public for testing purposes.

At least 17 babies were known to have been born in the US with thalidomide-related defects.

By 1962, the horrors caused by the drug were widely known and it began to disappear from the shelves.

Doctors discovered it had some effectiveness for treating leprosy and in the 1980s it was re-purposed to treat a form of cancer, called multiple myeloma, by stopping the growth of blood vessels to feed the tumors.

This discovery cast thalidomide in a new light, suggesting it could be a powerful tool in the fight against cancer, but its mysterious and gruesome birth defects have remained a barrier to its use and the development of more related drugs.

In recent years, Researchers at Dr Eric Fischer's lab at the Dana Farber Cancer Institute have sought to start clearing that barrier.

Leprosy treatment

In 1964, Israeli physician Jacob Sheskin administered thalidomide to a patient critically ill with leprosy. The patient exhibited erythema nodosum leprosum (ENL), a painful skin condition, one of the complications of leprosy. This was attempted despite the ban on thalidomide's use, but results were favourable: the patient slept for hours and was able to get out of bed without aid upon awakening. A clinical trial studying the use of thalidomide in leprosy soon followed.[36]

Thalidomide has been used by Brazilian physicians as the drug of choice for the treatment of severe ENL since 1965, and by 1996, at least 33 cases of thalidomide embryopathy were recorded in people born in Brazil after 1965.[37] Since 1994, the production, dispensing, and prescription of thalidomide have been strictly controlled, requiring women to use two forms of birth control and submit to regular pregnancy tests. Despite this, cases of thalidomide embryopathy continue,[38][39] with at least 100 cases identified in Brazil between 2005 and 2010.[40] 5.8 million thalidomide pills were distributed throughout Brazil in this time period, largely to poor Brazilians in areas with poor access to healthcare, and these cases have occurred despite the controls.

In 1998 the FDA approved the drug's use in the treatment of ENL.[41] Because of thalidomide's potential for causing birth defects, the drug may be distributed only under tightly controlled conditions. The FDA required that Celgene Corporation, which planned to market thalidomide under the brand name Thalomid, establish a system for thalidomide education and prescribing safety (STEPS) oversight program. The conditions required under the program include limiting prescription and dispensing rights to authorized prescribers and pharmacies only, keeping a registry of all patients prescribed thalidomide, providing extensive patient education about the risks associated with the drug, and providing periodic pregnancy tests for women who take the drug.

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