ConsumerLab.com Finds Generic Antidepressant Behaves Differently from Original Drug. May Explain Complaints by Patients.
— Generic Drug Equality Questioned —
WHITE PLAINS, NEW YORK AND DURHAM, NORTH CARLOLINA — OCTOBER 12, 2007 — ConsumerLab.com reported today that its tests of a generic version of the popular antidepressant drug Wellbutrin showed differences between the generic and original that might explain recent consumer complaints about the generic product. In February, readers of The People's Pharmacy® syndicated newspaper column began reporting problems with this generic version of once-a-day Wellbutrin XL 300. Prior to generic competition, annual U.S. sales of Wellbutrin XL 300 mg were nearly one billion dollars according to IMS.
The ConsumerLab.com report, available at www.consumerlab.com/results/wellbutrin-bupropion.asp, shows that the generic product released the active ingredient, bupropion hydrochloride, at a very different rate than the original Wellbutrin XL. Tests also showed that two generic bupropion SR (twice-a-day) products released the drug somewhat differently than one another — although both were within the fairly wide limits permitted by the FDA. Time-released generic drugs often use tablet technologies different from the original product, possibly explaining the variations found.
Personal accounts posted at www.peoplespharmacy.com generally indicate that while taking the brand name antidepressant Wellbutrin XL 300 , people felt well and their psychological symptoms of depression were successfully controlled. After switching to a generic formulation, many reported symptoms such as headaches, irritability, nausea and insomnia — known side-effects of bupropion. Others shared stories of becoming easily upset or aggressive, crying, gaining weight or experiencing a return of depressive symptoms. Some reported thoughts of suicide. Returning to the original product brought symptoms under control for many people.
Joe and Teresa Graedon, co-authors of The People's Pharmacy®, immediately reported these cases to officials at the Food and Drug Administration who assured the Graedons that the FDA would look into the issue. The agency has not yet reported the results of its investigation. The Graedons, aware of ConsumerLab.com's experience in testing health and nutrition products, suggested that it initiate laboratory testing to see whether there was any measurable difference between the generic formulation and the originator product.
Tod Cooperman, MD, President of ConsumerLab.com, stated, "Generic drugs can significantly reduce pharmaceutical costs, but consumers and healthcare providers need to be aware of the potential differences among products. Even if the active ingredient is the same, generics that release ingredient at a different rate may act differently in the body. Generics are not clinically tested for safety and efficacy, so the consumer will be the first to find out if there is a problem." ConsumerLab.com intends to publish additional reports about generic drugs on its website.
The full report is available to ConsumerLab.com subscribers at www.consumerlab.com/results/wellbutrin-bupropion.asp. The report includes test results of products distributed by GlaxoSmithKline, Global Pharmaceuticals (a division of Impax Laboratories), Teva Pharmaceuticals, and Watson Laboratories. It also provides information about other generic versions of bupropion and a list of popular extended-release generic drugs. The testing was funded by ConsumerLab.com without drug company involvement.
The Graedons and The People's Pharmacy® receive no financial support from pharmaceutical companies. Reports of generic drug problems by consumers are posted at www.peoplespharmacy.com.
ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. Reviews of popular types of vitamins and supplements are also available at www.consumerlab.com. Soon to be released are new Product Reviews of magnesium, omega-3 and -6 fatty acids, potassium, resveratrol (red wine extract), and turmeric. Subscription to ConsumerLab.com is available online. The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.
The People's Pharmacy® is a leading provider of consumer health information. Joe Graedon, MS, pharmacology, and Teresa Graedon, PhD, medical anthropology, have been writing a syndicated newspaper column (distributed by King Features Syndicate) for 29 years. They co-host The People's Pharmacy® radio show heard on more than 125 public radio stations. They have written more than 10 consumer-related health books that address pharmaceuticals, herbs and dietary supplements.
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