Health officials warn of fake Lipitor

By LAURAN NEERGAARD : AP Medical Writer
Jun 4, 2003 : 2:22 am ET

WASHINGTON -- Federal health officials warned users of the top-selling cholesterol medicine Lipitor to check if they have a fake version, as investigators uncovered more than 30,000 additional bottles containing counterfeit pills.

The maker of real Lipitor, Pfizer Inc., filed suit Tuesday to stop a pharmaceutical repackaging company and distributor from selling any more fake pills. Repackager Med-Pro Inc. and Albers Medical Distributors both denied involvement in the counterfeiting.

There are potentially significant health risks because the fake pills will not lower cholesterol.

The Food and Drug Administration first uncovered three batches of fake Lipitor almost two weeks ago, and ordered Kansas City, Mo.-based Albers to recall 100,000 bottles. The FDA announced Tuesday it had turned up three more batches containing counterfeit pills.

To spot the fake version, look for the words "Repackaged by MED-PRO Inc., Lexington, NE 68850" on 90-tablet bottles that bear any of the following lot numbers:

--20842V, expiration 09-2004

--16092V, expiration 07-2004

--20722V, expiration 09-2004

--04132V, expiration 01-2004

--16942V, expiration 09-2004

--D270481, expiration not available.

All but that last batch are 10-milligram tablets; the last one includes 20-milligram tablets.

Many patients taking Lipitor buy it in smaller quantities dispensed in different bottles by their local drugstore. Patients not sure if they have the counterfeit version should call their pharmacist, who can check the pills' source, the FDA advised.

"We want consumers, if there's any doubt at all, to call their pharmacist," FDA Associate Commissioner John Taylor said.

Pfizer said the counterfeit pills appear to have a limited distribution. Millions of people take Lipitor, the top-selling brand of cholesterol-lowering medicines known as statins.

Pfizer said the fake pills bear a close resemblance to real Lipitor, although they may be slightly thicker. Consumers have reported that the fake pills dissolve faster and have a slightly bitter taste. A handful of consumer complaints about the taste prompted the FDA's probe.

Drug manufacturers typically sell their products to a wholesaler that in turn sends tablets either directly to pharmacies, or to a distributor and repackager before they arrive at drugstores.

Pfizer sued Med-Pro and Albers on Tuesday, saying it has no relationship with either of the companies so far identified as handling the fake pills. The company said most Lipitor arrives at pharmacies without such middlemen.

"We're suing to get the product off the market and to identify the source," Pfizer spokeswoman Vanessa McGowan said.

Med-Pro and Albers denied involvement.

"Med-Pro acted at all times in good faith and was never knowingly involved in counterfeit Lipitor," company attorney J.R. Hobbs said.

Albers attorney Kathy Dean said the fake pills never came to the distributor's warehouse but were directly shipped from Med-Pro to a small number of wholesalers.

"We are cooperating fully with the FDA and are willing to work with Pfizer to identify the true source of the counterfeit product," she said.

More counterfeit medicine is turning up in the United States. In the last year, the FDA has investigated more than half a dozen cases. Just last month, three men were charged in Miami with a counterfeiting scheme that sold bacteria-tainted water in the guise of the anti-anemia medicine Procrit.