I’ve been suspect of certain generic medications for quite some time, much to the frustration of certain pharmacists and physicians who staunchly defend their quality and efficacy. Apparently, the FDA is now concerned as they have recently begun a 20 million dollar testing program on generic drugs that involves at least a dozen academic medical centers in the U.S.
In light of the problems with a number of generic drugs and that 80 percent of prescriptions in the U.S. are for generic medications, it’s about time the FDA started a testing program on a grander scale.
Check out these facts:
2014: The U.S. imposed restrictions on India’s generic drug manufacturer, Ranbaxy, and banned imports of products made at their newest factory due to quality and safety concerns such as falsified drug test results and selling fake medicines. This is the third time Ranbaxy imports have been blocked in the U.S. since 2008. See New York Times article here
2013: The U.S. banned imported drugs from specific Ranbaxy plants. In May of the same year the company pleaded guilty to federal drug safety violations and paid 500 million in fines and penalties. See New York Times article here
2012: Ranbaxy exported generic Lipitor to the U.S. but the company stopped production of this drug after tiny pieces of glass were found in the tablets. See CNN article here
2012: The FDA recalled the generic form of Wellbutrin 300mg XL exported from Impax Laboratories and marketed by Israel-based Teva Pharmaceuticals, because it was ineffective. See the Forbes article here
At first the FDA ignored patients’ complaints about certain generics. In 2012, The People’s Pharmacy notified the FDA about hundreds of patients who registered complaints about side effects of the generic Wellbutrin 300mg XL. According to the Forbes article, A Drug Recall That Should Frighten Us All About The FDA, “The FDA brushed off The People’s Pharmacy and others that raised the issue,” and suggested that people who had a mental disease were more prone to perceived problems with a change in medication than others.
In a 2009 report, the FDA revealed that the generic Wellbutrin 300mg XL had never undergone bioequivalence testing but based on the 150mg tests, it had approved the 300mg version. The FDA recalled the generic Wellbutrin 300mg XL medication in October of 2012.
At least 40 percent of generics are made overseas and 80 percent of the active ingredients in those drugs come from foreign plants. In 2009 the FDA inspected only 11 percent of the more than 3,700 foreign facilities where drugs and active ingredients are made for the U.S. market, according to a 2010 report to Congress from the Government Accountability Office. See link here
It would appear that the U.S., at present, has little control over the generics it imports. Even as of today, the FDA’s website still states, “A generic drug is identical-or bioequivalent-to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
But we don’t really know that, do we?
Thank goodness for The People’s Pharmacy and others like it that take patients’ complaints seriously. Not all pharmacies do.
Case in point—a pharmacist recently told me that the breathing problems I experienced while taking a generic drug, were psychosomatic. Yes, he actually said that. This was after I’d tested the drug several times (several days on it, several days off, then repeat and repeat.) I suspect that my side effects were a result of the inactive ingredients in the generic drug. The inactive ingredients in generic drugs are not required to be the same as brand medications.
To compound the problem, The Supreme Court ruled in 2013 that makers of generic drugs could not be sued under state law for adverse reactions to their products. Makers of brand medications can be liable for inadequacies in safety warnings. This is a major loophole for pharmaceutical companies since generics are not consistently tested for efficacy and impurities. See Washington Post article here
The FDA’s new generic drug testing program will run through 2017 and will focus on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medicines, and antidepressants.
That’s a long time to wait. What are patients to do until then?
Tips for patients who experience problems with certain generic medications:
1. If you have undesired side effects from a generic drug or suspect that it isn’t working, report it to your doctor, pharmacist and to the FDA’s MedWatch website.
2. Ask your pharmacist or provider to switch you to a different generic.
3. Ask your doctor to do a pre-authorization for the brand form of the prescribed medication. No guarantees that your health insurance will approve it, but it’s worth a try.
4. Pay attention to your body and any symptoms if you have started a new medication. You might try creating a journal/diary of symptoms and log in the side effects, day and time, so you have a complete grasp of the problem.
5. Speak up.
More information on this topic:
Dirty Medicine, CNN Money
Medicines Made in India Set Off Safety Worries, The New York Times
Generic-Drug Testing Goes Widespread in U.S. FDA Effort, Bloomberg News
FDA Chief to Focus on Generics’ Safety on Visit to India, Bloomberg News
I welcome your comments!