- The drug maker issued a recall for atorvastatin, but gave no directions to users
- Ranbaxy Pharmaceuticals and the FDA "are being less than helpful," an observer says
- Express Scripts and CVS locations are telling patients it's OK to take the pills
Despite a recall, millions of people may continue taking a generic form of Lipitor that might contain specks of glass.
Ranbaxy Pharmaceuticals issued the recall at the retail level November 9, directing pharmacies not to dispense contaminated lots of the drug, but gave no directions to patients who have the drug at home.
It's made for a confusing situation for patients taking Ranbaxy's atorvastatin, the generic form of Lipitor.
"Patients are sandwiched between two groups who are being less than helpful: the FDA and Ranbaxy," said Lisa Gill, editor of prescription drugs at Consumer Reports.
A Food and Drug Administration spokeswoman couldn't explain why the recall didn't direct consumers to stop taking the drug even though patients might have received the contaminated pills.
The spokeswoman, Sarah Clark-Lynn, referred questions about the recall to Ranbaxy, which issued a one-paragraph statement on its website and did not return phone calls and e-mails from CNN.
The statement said that "select batches" of the medicine may contain "small glass particles approximately less than 1mm in size" and that the recall was being conducted "out of an abundance of caution." It did not give consumers guidance about what to do with supplies of the drug at home.
"In my recent memory, there has never been anything like this," Gill said. "It makes my palms sweat just thinking about it."
Advice to patients
Between 3 million and 4 million people take Ranbaxy's atorvastatin, according to Ross Muken, senior managing director at ISI Group. The company has over a 40% share of the generic Lipitor market.
One major pharmacy, Express Scripts, is telling patients it will not exchange Ranbaxy atorvastatin for another brand, according to Brian Henry, vice president of corporate communications for Express Scripts.
"Ranbaxy, in conjunction with the FDA, has determined there are no safety concerns associated with continued use of atorvastatin in the patients' possession," a recorded message tells consumers who call Express Scripts.
Pharmacists at several CVS pharmacies said it was all right to keep taking already-filled prescriptions of Ranbaxy atorvastatin, but the company would exchange it for another brand at a customer's request.
Consumer Reports is advising consumers to take potentially contaminated medicine back to the pharmacy and request another brand, Gill said.
A company with a history
Ranbaxy, India's largest pharmaceutical company and the 12th largest generics maker in the world, has had quality problems in the past.
The FDA has accused the company of "a pattern of systemic fraudulent conduct," including taking shortcuts in crucial quality tests. So widespread and grave was the misbehavior that in 2008 the FDA barred Ranbaxy from importing 30 drugs into the United States.