Celgene Inc., in cooperation with Health Canada, the government health regulatory agency, has issued a safety warning about the risk of blood clots with the drug Thalomid (thalidomide).
While uncommon, blood clots in the arteries can happen in patients taking Thalomid, especially during the first five months of use, Health Canada said. Some clots have resulted in death due to heart attack or stroke. A blood clot in the heart can cause chest pain, which can spread to the arms, neck, jaw, back or stomach, and the patient may also feel sweaty, out of breath, and nauseated. A blood clot in the brain can cause difficulty in seeing or speaking, which may be signs of a stroke. Patients who experience these symptoms should seek medical help immediately.
Health Canada has 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 here by the U.S. Food and Drug Administration (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. Thalidomide was responsible for severe limb deformities and other birth defects in the early 1960s, when it was on the market as a sedative.
Health Canada encourages patients and doctors to report any side effects or adverse events with Thalomid. Information on how to report online, by mail or by fax can be obtained by visiting MedEffect Canada’s web page on Adverse Reaction Reporting. In the U.S., patients and healthcare professionals can report adverse events or side effects through the FDA’s MedWatch program, www.fda.gov/MedWatch/report.htm, or by phone at 1.800.332.1088.