Thalidomide Long Tied to Serious Side Effects, Including Birth Defects

thalomide_birth_defectsThalidomide was responsible for severe limb deformities and other birth defects in the early 1960s, when it was on the market as a sedative.

Today, Thalomid (thalidomide) is an immunomodulatory agent indicated for the treatment of patients who are 65 years of age or older and with a previously untreated multiple myeloma. Thalomid is prescribed in combination with melphalan and prednisone (MPT) and has been tied to an increased risk of second primary malignancies, according to Celgene Inc. and Health Canada. This serious, adverse side effect has been added to the drug’s Product Monograph in Canada.

Developed in the 1950s by the German company, Chemie Grünenthal, thalidomide was marketed in Europe as the first safe sleeping pill and was considered to be a very effective morning sickness remedy for pregnant women, according to The New York Times. In some countries in Europe, Thalomid enjoyed massive success, the Times noted.

Thalidomide was tied to severe birth defects in 1956 when the daughter of a Grünenthal employee was born without ears. She was soon followed by thousands of other babies born worldwide with physical disabilities that included flipper-like limbs. The rash of babies born with birth defects led to horrific responses, including parents abandoning and institutionalizing their babies, having the flippers amputated and replaced with prostheses, and one mother and physician mercy killing her baby, the Times reported.

In the United States the drug was prevented from being approved after Dr. Frances Oldham Kelsey, a pharmacologist who had just begun working at the U.S. Food and Drug Administration (FDA), was asked in 1960 to review thalidomide for approval. Concerned over the lack of rigorous research in support of the drug’s safety by Grünenthal and William S. Merrell, the U.S. distributor, she asked Grünenthal for data and delayed approval; in November 1961, evidence became public in Germany that linked the drug to serious birth defects, according to the Times.

In subsequent court cases there, the drug maker blamed nuclear fallout or botched home abortions and only finally apologized to the children and their families in 2012.

Thalidomide did not receive FDA approval and, in 1962, was banned worldwide; however, in the early 1990s, researchers learned that the same properties in thalidomide that restricted blood vessel growth, which led to stunted limbs, could treat a variety of conditions such as some cancerous tumors, including multiple myeloma; multiple sclerosis; and Crohn’s disease, the Times reported. In Brazil, the medication is seeing widespread use in the treatment of leprosy and at least 100 children there have suffered from thalidomide disabilities since 2005, despite that thalidomide contains a strict warning that it is not to be used by pregnant women.

In Canada, Thalomid is only available through a controlled distribution program. We also previously wrote that Celgene Inc. and Health Canada issued a safety warning about the risk of blood clots with Thalomid. Health Canada authorized the use of Thalomid in very limited circumstances to treat multiple myeloma in patients 65 years of age and older.

Thalidomide is approved for this use in the U.S. by the FDA, as well as to treat new lesions of leprosy. Both health agencies warn that Thalomid should never be taken by women who are pregnant or who could become pregnant while taking the drug. Even a single dose taken by a woman during pregnancy can cause severe birth defects or death to an unborn baby.

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