More Side Effects… Less Effective?
Generic drugs cost 30% to 80% less than their brand-name counterparts and most people feel safe taking them because the FDA requires that both types of medications provide the same active ingredients and level of effectiveness.
Recent development: A 2006 survey found that about 25% of 300 doctors throughout the US don’t believe that generics are chemically identical to brand-name drugs… nearly one in five believe that generics are less safe… and more than one in four believe that generics cause more side effects.
So what’s the truth about generic drugs?
WHAT PATIENTS SAY
Since 1976, when our book The People’s Pharmacy was originally published as a consumer guide to drug and health information, thousands of patients have contacted us about their experiences with medications.
In the last few years, we’ve received hundreds of letters and E-mails — most of them complaints — about generic drugs, including pain relievers, antidepressants and blood pressure medicines. The number of such complaints has increased dramatically in that time.
What we’ve learned: Some patients who switch from a brand-name to a generic drug report a decline in effectiveness — for example, blood pressure that isn’t controlled as well or a worsening of depression. Others report having a rash or other types of allergic reactions, probably due to one of the inactive “filler” ingredients in generic drugs. There also seem to be problems with the timed-release mechanism of some generics.
Example: We’ve heard more than 100 complaints about a generic version of the long-acting anti-depressant Wellbutrin XL. At least one manufacturer’s timed-release generic formulation appears to be different from the brand name — and may be releasing too much of the drug too quickly (known as “dose dumping”). This would explain many of the side effects, such as headaches and anxiety, that some people tell us they experience when they take the generic drug, but not the brand-name version.
We’ve contacted the FDA about the complaints regarding this generic drug, and we’re also working with an independent laboratory to analyze this formulation.
IS THE FDA DOING ENOUGH?
Drug companies must apply to the FDA to sell generic versions of drugs. To gain FDA approval, a generic drug must contain the same active ingredients as brand-name medications and meet the same criteria for such factors as quality, strength and purity. Possible problems with generic drugs…
Trap: Overseas plants are inspected much less frequently than those in the US. Without testing, there’s no way to tell whether drugs and drug ingredients derived from these plants have impurities — or come in “subtherapeutic” doses (for example, a drug labeled as 10 mg may be only 6 mg).
Most of the evidence for problems with generic drugs is based on anecdotal reports. However, research published in Neurology in 2004 reported that people with epilepsy who switched from the brand-name form of the antiseizure drug phenytoin (Dilantin) to the generic form of the drug began to have higher-than-expected rates of seizures. Investigators found that in many patients, blood levels of the active ingredient had dropped by 30%. Even so, patients should not give up on generic drugs. The cost savings can be considerable… and there’s no evidence so far that the majority of generic drugs will cause problems for most patients. Patients using generic drugs should simply take extra precautions…
Important: Ask your doctor to give you copies of your test results. Check them periodically to make sure that you’re maintaining adequate control — particularly if you’ve recently switched from a brand name to a generic, or the reverse.
If you’d also like to report problems with generic drugs to us, go to The People’s Pharmacy Web site, www.peoplespharmacy.org.
*Go to the FDA Web site, www.fda.gov/medwatch, or call 888-463-6332.