Lipitor has been the most successful drug in the history of the pharmaceutical industry. Nothing else even gets close. Sales of Lipitor exceeded more than $130 billion. In its heyday millions of people took this brand name medication and insurance companies paid top dollar for a drug doctors loved to prescribe to control cholesterol. It should come as no surprise that HMOs, insurance companies and many patients were thrilled to learn that Lipitor lost its patent last November and would become available as generic atorvastatin at a reduced price.
The first manufacturer to market a generic version of Lipitor in the U.S. was an Indian company called Ranbaxy. It is the largest generic drug manufacturer in India and sells a huge amount of generic medicine in the U.S. Because it was the first off the starting line, Ranbaxy dominates generic sales of atorvastatin. Experts estimate that this Indian company has about 60 percent of the market for the most popular statin-type cholesterol-lowering drug.
That is why it has come as such a shock to learn that Ranbaxy is pulling its 10-, 20- and 40-milligram doses of atorvastatin from the U.S. pharmacy shelves. The problem: 41 lots of atorvastatin were apparently contaminated with small glass particles. You can go to the Ranbaxy website for lot numbers. Here is a link so you can check for yourself.
This is not the first time Ranbaxy has got itself into a pickle. In August, 2008, we wrote the following:
“A story that was virtually ignored by the mainstream press and disappeared almost without a trace has to do with serious allegations against Ranbaxy Laboratories, an Indian drug company. Ranbaxy is not just any drug company. It is the largest pharmaceutical company in India, by sales. The company has huge sales around the world, thanks in large measure to its dominance in the generic drug arena. Not surprisingly, Ranbaxy sells a LOT of meds in the U.S.
“According to reports, Justice Department investigators are concerned that Ranbaxy may have submitted false claims, fabricated documents and committed fraud in drug submissions to the FDA.
“Congress is getting into the act. Leaders of the House Committee on Energy and Commerce have put the FDA on the hot seat, raising questions about what FDA staffers knew about this and when they knew it. There are court documents suggesting that FDA has been aware of trouble at Ranbaxy for at least 18 months. FDA apparently did nothing to warn physicians, patients or pharmacists of the suspected problems.
“If Ranbaxy fabricated evidence for its generic drug applications to the FDA and concealed violations of manufacturing practices, this is a big deal. We have been questioning the ability of the FDA to monitor the quality of generic drugs for several years. (Read some of the reports on this site for frightening examples of apparent generic shortcomings.) We suspected that some companies in China and India may have taken short cuts. If the Ranbaxy mess proves true, we will know that our fears were justified. We wonder how many other problems may not have been detected by the FDA.”
In the fall of 2008 the FDA banned importation of 30 generic drugs (including statins such as pravastatin and simvastatin and the antibiotic ciprofloxacin) from Ranbaxy Labs. The agency cited lapses in manufacturing process and quality control. The U.S. Department of Justice pursued separate action, alleging that Ranbaxy distributed adulterated and misbranded products. In other words, the company was accused of forging documents and fudging key information.
Is it any wonder we have been concerned about generic drug quality? Over the last several years there have been problems with the Actavis Group, which had to voluntarily recall 800 million digoxin tablets [a critical heart medicine] because of doubts about the dose. KV Pharmaceutical got into trouble as did Sandoz and Caraco. Over 100 different generic drugs have been recalled over the last few years, resulting in drug shortages of key medications.
WHAT’S A PATIENT TO DO?
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. Ask your pharmacist whether you can bring or send (in the case of mail-order) the pills back in return for either Lipitor or non-recalled generic atorvastatin. Your insurance company should make good and not require another co-pay for the substituted atorvastatin.
In the event of shortages of generic atorvastatin (a distinct possibility), you may need to ask for Lipitor or another statin-type drug to cover you during this period when Ranbaxy will be out of the game with its most popular atorvastatin dosage forms.
The sad reality of this recall is that once again confidence in generic drugs has been shaken. The FDA’s ability to monitor generic drug manufacturing and quality is under question. Of course there have also been problems with brand name companies over the last few years. Johnson & Johnson got into trouble with products such as Motrin, Zyrtec, Tylenol and Benadryl at its plant in Fort Washington, PA.
If the FDA has trouble ensuring the quality of a major brand like Tylenol made in the U.S., it’s hardly any wonder it has challenges in China and India where most of today’s generic drugs are manufactured.
To learn more about the generic drug problem in the U.S. you may want to read our chapter, “Generic Drug Screwups” in our book Top Screwups Doctors Make and How to Avoid Them. You will learn details about our
Top 10 Tips for Taking Generic Drugs:
- Make no assumptions
- Keep track of the manufacturer
- Keep records
- Ask for your lab results
- Monitor symptoms
- Listen to your body
- Challenge and rechallenge
- Be assertive
- Seek allies
- Report any problems to the FDA
The removal of Ranbaxy’s atorvastatin is just the latest in a long line of generic recalls over the last few years. On top of the generic methylprednisolone injections that were contaminated with fungus at the Massachusetts compounding pharmacy, we are left with grave doubts about the ability of our federal (and state) regulators to ensure the quality of our drug supply.
Consumers and patients will need to be ever more vigilant. If you suspect that your medicine is not working as expected, please let us know. Also report any concerns to your physician, your pharmacist and the FDA. Although the agency does not have adequate resources to inspect all drug manufacturing plants abroad, the feds do have the responsibility to pay attention to patients who report difficulties and then make an honest effort to track down the source of the problem.