Millions of people could possibly be taking a generic form of Lipitor even though there was a recent recall claiming the medication contained specks of glass.
Ranbaxy Pharmaceuticals, the maker of atorvastatin, 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.
So, many are left not knowing what to do? Will their pharmacy replace the medication they already purchased? How many are actually affected? What does the FDA say about it?
Based on concerns, The Food and Drug Administration advised concerned consumers to stop taking the popular cholesterol drug if the pills came from one of 41 recalled lots, and even though as stated the recall was 3 weeks ago, this is the first time someone has said stop taking the pills.
But, even with these new guidelines, some pharmacies are still telling customers it’s safe to take the drug.
“Patients should continue to proceed as they normally would,” said Brian Henry, vice president of corporate communications at Express Scripts, on Thursday, November 29. He added that the company would not give customers refunds for the generic Lipitor, or atorvastatin.
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.
Henry explained that this was a “pharmacy-level recall,” meaning pharmacies must stop dispensing contaminated lots of the drug, but consumers could keep taking what they already had at home — even though the FDA has confirmed that some of the contaminated drug may have reached consumers.
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.
“This whole thing is confusing for consumers,” said Lisa Gill, editor of prescription drugs at Consumer Reports.
She also expressed concern that it took the FDA nearly three weeks to issue guidance to consumers.
“It’s not clear why it took them so long,” she said. “It’s surprising.”
In its statement Thursday, the FDA said that the glass particles were “similar to the size of a grain of sand” and that “the possibility of adverse events related to the recalled product appear to be low.”
To make matters worse, the FDA has directed concerned consumers to call their pharmacies to see whether their pills had been recalled, as not all lots of the drug are affected.
However, pharmacists say they have no way of figuring out what lot number a bottle of pills came from.
“The ability to tie a specific prescription to a lot number would be very difficult,” said Ronna Hauser, vice president of policy and regulatory affairs at the National Community Pharmacists Association.
The FDA announced at the same time that Ranbaxy would stop making atorvastatin while it investigates how the glass might have gotten into the drug.
The spokeswoman, Sarah Clark-Lynn, referred questions about the recall to Ranbaxy.
Ranbaxy simply 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.
“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.
“In my recent memory, there has never been anything like this,” Gill said. “It makes my palms sweat just thinking about it.”
Consumer Reports is advising consumers to take potentially contaminated medicine back to the pharmacy and request another brand, Gill said.