The US Food and Drug Administration has issued a warning on the use of Schering AG’s multiple sclerosis drug Campath.
The FDA said three patients in a clinical study on the drug developed severe idiopathic thrombocytopenic purpura (ITP), a rare autoimmune disorder characterised by an acute shortage of platelets with resultant bruising and spontaneous bleeding.
One of the patients died, the FDA said.
Campath is so far not approved to treat MS. It is only approved for treating a form of blood cancer called B-cell chronic lymphocytic leukemia (B-CLL).
The label for Campath has a warning about serious and rare blood problems that may occur with the use of this medicine.
Schering could not be reached for comment.