There was a time when most of the prescriptions filled in America were for branded drugs. Valium, Prozac and Lipitor were household names.
Now, the vast majority of prescriptions are filled with generic equivalents. The names are frequently tongue twisters. Diazepam, fluoxetine and atorvastatin are not as easily pronounced or remembered as their brand names were.
The Food and Drug Administration has maintained for decades that generic drugs are identical to their brand name counterparts. That is why insurance companies and other payers often refuse to pay for a brand name pill.
Now, the FDA is reevaluating its position on generics, especially those designed to release their ingredients slowly. This is partly a result of People’s Pharmacy readers reporting their difficulties with a long-acting formulation of the antidepressant bupropion.
Shortly after the generic drug Budeprion XL 300 was introduced, some people who had taken the brand-name Wellbutrin XL 300 started telling us that the generic was not working the same. We passed these reports on to the FDA. Eventually the agency conducted its own study to see whether Budeprion XL 300 got into the system the same way as Wellbutrin XL 300. When it did not, the FDA asked the manufacturer to remove this antidepressant from the market.
This has prompted a change in policy, according to Gregory Geba, MD, MPH, director of the Office of Generic Drugs. Extended release formulations are often indicated by abbreviations like CD, CR, ER, LA, SR, XL, XR and XT. There are hundreds of such products because they are more convenient than medications taken two or three times a day.
Most people don’t realize that the technologies that allow for slow release of ingredients may differ between the brand and the generic versions. That’s because the formulation that allows for slow release can be under a separate patent from the active drug ingredient.
To release the medicine in a controlled manner, manufacturers have developed sophisticated coatings, laser-cut holes or special pelleting processes. The generic manufacturer may not have permission to use the same technique. Substituting a different type of slow-release approach, as was the case with Budeprion XL 300, may change the way the drug gets into the bloodstream.
Now that the FDA has come to grips with this potential problem, it appears to be raising the bar for generic manufacturing going forward. Questions remain, however, about the performance of some generic drugs approved under the old guidelines.
Many readers have reported problems with slow-release generics: “I was on Toprol-XL after heart bypass several months ago. My systolic blood pressure was perfect at around 120. When I was switched to generic metoprolol my blood pressure went to the 170 range.” Others have noted irregular heart rhythms on generic metoprolol but not on Toprol-XL.
Here are some other scary stories:
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“My husband has been on Keppra for two years. After receiving the generic Keppra prescription levetiracetam he has been having seizures on a daily basis. We are now scheduled with a seizure specialist because of this new situation. This has only began since introduced to the generic Keppra. I am very concerned. Is this being reported in the news?”
Denise
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“I want to report a serious problem with a generic drug. Is there a specific place to report it or should I just use the FDA adverse event form? Is there only one form? It seems designed for people who have been injured. What if you just want to report that a generic drug was completely different from the brand?
My problem was with sertraline (generic for Zoloft). It caused me to go into abrupt total SSRI withdrawal like I had taken nothing. So I was injured but not in the way that the FDA form seems designed for. After they finally admitted to SSRI withdrawal effects and added the “discontinuation syndrome” warning, it’s ironic that the failure of the generic caused me to go into sudden, unintended withdrawal. It was very scary!”
Becca
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The FDA has not made it easy to report generic drug failures. And it is unclear whether the agency has committed staff to the exclusive job of tracking down these generic drug problems. Rarely, if ever, does the FDA follow-up with patients, physicians or pharmacists who report that a generic drug failed. For years the FDA denied that there could even be a problem.
We do NOT want to discourage the use of generic drugs. They make up roughly 80% of all drugs dispensed these days and they save us a ton of money. We do want the FDA to take reports of generic drug failures more seriously. We also want doctors and pharmacists to believe patients when they report serious problems with generic drugs. And we want insurance companies to stop falling back on the claim that all generic drugs are identical to their brand name counterparts. We now know that is not always true! Finally, we want the FDA to monitor generic drug manufacturing better and make sure there is improved quality control. Random testing of products off pharmacy shelves would be a good start. The honor system that currently exists just isn’t working.
To learn how to report problems and use generic drugs safely, you may find our “Top 10 Tips for Taking Generic Drugs” helpful. They are in our book, Top Screwups Doctors Make and How to Avoid Them, available in libraries, bookstores and online at PeoplesPharmacy.com.
