FDA investigates sale of fake AIDS drug

LAURAN NEERGAARD / AP 22jan01

WASHINGTON -- AIDS patients should immediately check that they weren't sold a counterfeit version of the prescription drug Serostim, because the fake could be dangerous, Serostim's maker warned Monday.

The Food and Drug Administration has launched a criminal investigation to track down whoever sold the fake drug, which so far has been found in seven states but could have been sold nationwide.

The composition of the fake substance is not known. So far, its only reported side effects are skin irritation and redness where patients injected the substance. But officials noted that AIDS patients risk at least getting worse if they go without their real Serostim.

Serostim is an injected medicine used by about 6,000 AIDS patients to fight the dangerous wasting that the virus can cause.

Manufacturer Serono Inc. says about 10 people initially received the counterfeit version from pharmacies in California. So far, the FDA has discovered the fake drug in six other states -- Ohio, Kentucky, Michigan, New Jersey, Florida and Missouri.

Norwell, Mass.-based Serono first learned of fake Serostim when it received phone calls from California consumers, longtime Serostim users wondering why their newest batch looked different or reporting unexpected skin irritations.

Laboratory tests showed the substance wasn't Serostim but an elaborate fake, sold in boxes that closely resemble real Serostim packages.

Serono alerted pharmacists and AIDS organizations to the problem in late December; the FDA told Serono to issue a broader warning Monday to ensure all AIDS patients get the word.

How to tell the fake Serostim from the real version? The fake drug bears lot MNK612A, which is a real lot number also found on an authentic batch. But the fake version bears the expiration date 08/02. Genuine Serostim with that lot number bears the expiration date 08/01.

Other clues:

• Inside the Serostim box are two vials, one containing the drug, the other a diluent. The real drug looks like a one-eighth-inch white ``cake'' resting in the bottom of one vial. The fake drug vial contains white, snow-like powder throughout the vial and sometimes stuck to the stopper.
• The real diluent vial bears the lot number 99H124; the fake diluent vial says lot 99h124.
• Fake Serostim has a dark blue label bearing the lot number and expiration date attached to one end of the outer carton. Real Serostim has no attached label but has a dark blue box printed directly onto the carton, in which the lot number and expiration date are printed.
  
  

• Food and Drug Administration: http://www.fda.gov