Arthritis Drug Warning Issued
Thursday, October 12th 2000, 12:00 am
By: News On 6
WASHINGTON (AP) â€” Doctors should be cautious in prescribing a novel rheumatoid arthritis treatment to patients who also have multiple sclerosis, and should watch out for serious anemia in anyone who uses the drug, the manufacturer warned Tuesday.
There's no proof Enbrel actually causes or worsens MS symptoms, or that it causes dangerous anemia, the Food and Drug Administration said.
But manufacturer Immunex Corp. wrote 100,000 doctors and pharmacists Tuesday to alert them that rare cases of both problems have been reported in Enbrel users, and thus physicians should consider precautions when treating certain patients.
Among the reports: 11 cases of certain ``demyelinating'' diseases â€” a specific type of nerve disorder that includes MS â€” and 10 cases of blood-cell shortages, including dangerous aplastic anemia, that leave patients vulnerable to infection. Five of those blood-disorder patients died.
Reports of problems are rare â€” more than 80,000 people have taken Enbrel since the FDA approved it in late 1998. It is considered highly effective at treating painful rheumatoid arthritis, and at slowing the disease's joint destruction.
But last year, the FDA warned that six Enbrel users had died of infections, warning that doctors should watch for serious side effects.
Because the anemia can be life-threatening, patients should seek medical care if they develop such symptoms as persistent fever, bruising, bleeding or pallor, Immunex warned. Doctors should consider stopping the drug if patients have significant blood abnormalities.
As for MS, there is no evidence it strikes Enbrel users more often than it strikes the general population, cautioned FDA's Dr. Karen Weiss. But Enbrel works by targeting a specific immune system protein called TNF â€” and studies of two other TNF-targeting drugs, including a competing rheumatoid arthritis treatment, have raised suggestions that blocking that protein might increase MS symptoms. So MS patients who also have arthritis should consider the reports in picking a treatment, Weiss explained.
On the Net:
Food and Drug Administration: http://www.fda.gov