Serious Long-term and Short-term Side Effects
Campath manufactured by Schering and Genzyme Corp. Is approved to treat Leukemia. The FDA, on May 7, 2001 approved Campath. On September 16, 2005 Genzyme and Schering suspended dosages in a trial study for Campath after reports of three cases of serious side effects that lead to a death. The Phase II or mid-stage trial side effects consisted of three cases of Idiopathic Thrombocytopenic Purpura (ITP).
Idiopathic Thrombocytopenic Purpura (ITP) is a condition in which patients experience a low platelet count that can cause abnormal bleeding. Genzyme and Schering said they have notified regulatory authorities, trial sites and patients about risks. The companies have consulted a panel of experts to advise the companies on how to reduce risks of ITP.
Treatments for Multiple Sclerosis have recently been under the microscope after the drug Tysabri, made by Elan Corp. and Biogen Idec Inc. was removed from the market in February after it was linked to a rare and potentially fatal brain disease.