Phony Lipitor brings warning, recall

Deseret News (Salt Lake City), May 24, 2003 by Rick Weiss The Washington Post

WASHINGTON -- An estimated 100,000 bottles of the widely used cholesterol-lowering drug Lipitor are being recalled because they contain counterfeit pills that pose a potentially serious danger to consumers, the Food and Drug Administration warned Friday.

In an announcement laden with more urgency than often accompanies such reports, the agency encouraged health-care providers and patients to check "very carefully" the lot numbers and other labeling information on their supplies of the drug and immediately return any that bear key markings for the three lots in question.

The counterfeit products are in 90-tablet bottles with labels that say, "Repackaged by: MED-PRO, Inc. Lexington, Neb." in the lower left corner. The three lot numbers involved are: 20722V (exp. 09-2004); 04132V (exp. 01-2004); and 16942V (exp. 09-2004). Pills with those lot numbers but without the "MED-PRO" repackaging notation are not involved.

The agency did not release details about what was in the pills, citing an ongoing criminal investigation. Recall notices from the FDA often contain a phrase noting that the company involved is cooperating in the investigation, but no such statement was present in Friday's notice. A phone call late Friday to Albers Medical Distributors Inc., a national distributor of drugs and medical supplies that is recalling the counterfeit products, went unanswered, and a message was not returned.

Counterfeit drugs sometimes are dangerous simply because they lack the active ingredient that a patient needs. However, in the case of Lipitor, a so-called statin drug that is taken for the chronic condition of high cholesterol, failure to take the drug for some time would have no noticeable medical effect.

FDA's warning that the counterfeit pills pose a "potentially significant risk" to consumers -- and its acknowledgement that it became aware of the problem when one or more patients were diagnosed as having unspecified health problems as a result of taking the pills -- suggest that in this case the pills contain either the wrong drug, a toxin or are otherwise contaminated.

Lipitor (also known as atorvastatin) ranks No. 1 in sales for all prescription drugs worldwide, bringing its maker, Pfizer Inc., more than $8 billion in revenue last year. The agency did not say Friday what role Pfizer played in uncovering the fraud. But in a Talk Paper released Friday afternoon, the agency noted that the FDA this month had "entered in an agreement with a major pharmaceutical trade association to cooperate closely on cases of suspected counterfeit products."