By now you should have heard that the huge Indian generic drug company, Ranbaxy, finally agreed to halt production of its generic Lipitor (atorvastatin) because somehow glass particles got into the production line. Dozens of lots involving goodness knows how many pills were affected. Here is a link to the affected lot numbers.
What is incredible about this recall is the confusion both at the FDA and the drug company, as well as at local pharmacies, chain pharmacies and mail-order pharmacies. Patients were told all sorts of stories including something along the lines of, don’t worry, be happy, there is no problem with your pills even though they have been recalled. Just keep taking them as usual.
The FDA said that the glass particles are so tiny (“the size of a grain of sand”), that they aren’t risky. Just how would the FDA know that? Has anyone tested the impact of glass particles on the human digestive tract over weeks and months?
Here is just one message we have received from a visitor to this website. Henry wrote on November 30, 2012:
“I have been taking generic Lipitor (atorvastatin) since it first came out. At that time, the manufacturer Ranbaxy was the only source for the generic. Now it turns out that certain batches were found to be contaminated with glass particles and have been recalled at the retail level.
“I am worried that this contamination was present long before its recent discovery but can’t find out whether or not that is in fact the case. I have had abdominal problems of an unidentifiable nature for quite a while and wonder whether this medication could have brought this on. I have had two endoscopic exams as well as cat scans and ultrasound exams to determine the cause of my pain with the only thing found being a hiatal hernia which has not required any treatment.
“I have now switched to a different manufacturer as soon as I heard of this so I don’t have any idea if this will make a difference . It seems to me that minute particles of glass in my guts could create some real problems. Do you think the contamination in the medication could be responsible for my problems? I’m sure I’m not alone in my concern. Thank you.” –Henry
Sadly, we have no way of answering Henry’s very thoughtful question. Despite reassurances from Ranbaxy and the FDA that there is nothing to worry about, we have to agree with Henry that “glass in your guts” is probably not desirable, even if the particles are “tiny.” And obviously, the FDA and Ranbaxy thought the problem was serious enough to recall the affected lots of atorvastatin. By the way, it now turns out that Ranbaxy recalled 32,000 bottles of atorvastatin back in August (months before this latest debacle) because 20 milligram tablets were found inside bottles labeled 10 milligrams. That story did not get widespread publicity.
Not surprisingly, many pharmacies would prefer not to substitute new, non-Ranbaxy atorvastatin for the recalled product. Patients have been getting mixed messages about whether to return their old pills for new ones and who will pay. According to the Wall Street Journal (Nov. 29, 2012),
“Ranbaxy, which holds more than 40% of the U.S. market for atorvastatin prescriptions said Wednesday that the probability of an adverse health event due to consumption of the tablets recalled for potential glass particles is unlikely, but can’t be ruled out.”
We don’t know about you, but we don’t find that statement very reassuring. So, what is The People’s Pharmacy recommendation: If you are taking atorvastatin (10-, 20- and 40-milligram pills), contact your pharmacist to find out whether it came from Ranbaxy and whether your pills are part of the recalled lots. Tell your pharmacist you will bring or send (in the case of mail-order pharmacies) the pills back in return for either Lipitor or non-recalled generic atorvastatin. Do NOT accept no for an answer. Your insurance company should make good and not require another co-pay for the substituted atorvastatin. And please let us know how you make out.
We have found this entire event a boondoggle of classic proportions. Even Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research admits that “It took us some time to figure out what was going on. We need to fix our process a little bit.” We think that is an understatement.
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