Campath Linked to Autoimmune Diseases, Bleeding
Last Updated on June 26, 2017
Important Information
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At A Glance
- This Alert Affects
- Patients given Campath as part of their treatment for B-CLL, or off-label for Multiple Sclerosis
- Damages
- Idiopathic Thrombocytopenic Pupura (ITP), autoimmune disease leading to bleeding and bruising.
- Company(ies)
- Genzyme, Sanofi-Aventis.
- Additional Details
- Patients and authorities have been contacted by the manufacturer to advise about side effects and risks.
- Date
- FDA warning issued 2007
Campath (generic: Alemtuzumab) was approved by the FDA in 2001, and is manufactured by Genzyme, now Sanofi-Aventis. It is currently only approved to treat a form of blood cancer called B-cell chronic lymphocytic leukemia (B-CLL).
Campath Multiple Sclerosis Side Effects
In 2007 the FDA issued a warning following a trial of Campath which led to multiple cases of idiopathic thrombocytopenic pupura (ITP), an autoimmune disease which leads to bruising and bleeding caused by a dangerous shortage of platelets. The FDA also reported that a death was linked to the use of the drug, and manufacturers have contacted regulatory authorities and patients to advise about ITP and other risks.
Campath is not currently approved by the DFA for use with MS or for any treatment apart from B-CLL. It may also cause blood problems and has reportedly been linked to brain disease.
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