Counterfeit AIDS Drug Hits the Market
W A S H I N G T O N, Jan. 23 -- AIDS patients should immediately check thatthey weren't sold a counterfeit version of the prescription drugSerostim, because the fake could be dangerous, Serostim's maker haswarned.
The Food and Drug Administration has launched a criminalinvestigation to track down whoever sold the fake drug, which sofar has been found in seven states but could have been soldnationwide.
The composition of the fake substance is not known. So far, itsonly reported side effects are skin irritation and redness wherepatients injected the substance. But officials noted that AIDSpatients risk at least getting worse if they go without their realSerostim. The drug maker's warning came Monday.
Used by 6,000 AIDS Patients
Serostim is an injected medicine used by about 6,000 AIDSpatients to fight the dangerous wasting that the virus can cause.
Manufacturer Serono Inc. says about 10 people initially receivedthe counterfeit version from pharmacies in California. So far, theFDA has discovered the fake drug in six other states — Ohio,Kentucky, Michigan, New Jersey, Florida and Missouri.
Serono first learned of fake Serostim when it received phonecalls from California consumers, longtime Serostim users wonderingwhy their newest batch looked different or reporting unexpectedskin irritations.
An Elaborate Fake
Laboratory tests showed the substance wasn't Serostim but anelaborate fake, sold in boxes that closely resemble real Serostimpackages.
Serono alerted pharmacists and AIDS organizations to the problemin late December; the FDA told Serono to issue a broader warningMonday to ensure all AIDS patients get the word.
How to tell the fake Serostim from the real version? The fakedrug bears lot MNK612A, which is a real lot number also found on anauthentic batch. But the fake version bears the expiration date08/02. Genuine Serostim with that lot number bears the expirationdate 08/01.
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