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Drug Tests:Wellbutrin vs. Generic Bupropion
Initial Posting: 10/12/07 Last Updated: 10/17/13 Sections: Jump to a section by clicking on its name.
Concerns about Generic Wellbutrin: Background:
Generic drugs can make prescription medication much more affordable. But in early 2007, ConsumerLab.com became aware of reports by consumers experiencing problems when switching from Wellbutrin to its generic form (bupropion HCl). Wellbutrin is among the most popular anti-depressants. U.S. sales in 2006 were in excess of $1.8 billion according to Wolters Kluwer Health. The majority of these sales were of the XL (once-a-day) 300 mg product. Most consumer complaints were about a generic version of the XL 300 mg product launched in December 2006 as Budeprion XL 300 mg by Teva Pharmaceutical Industries.
Early this year, The People's Pharmacy, a syndicated radio program and newspaper column, began collecting and reporting consumer complaints about generic Wellbutrin, many of which can be viewed on its website at www.peoplespharmacy.org. The personal accounts generally indicated that while taking the brand name Wellbutrin XL 300 for months or years, people felt well and their psychological symptoms of depression were successfully controlled. After switching to the generic formulation, Budeprion XL 300, 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 while taking the generic form of Wellbutrin. A large number of accounts note that returning to the original product brought symptoms under control. These reports prompted ConsumerLab.com to investigate whether extended-release (XL) and sustained-released (SR) bupropion generics were truly equivalent to original Wellbutrin and to each other.
Different Pills — But Called Equivalent:
The active ingredient in Wellbutrin is off-patent while the method for delivering it in time-released tablets is still patent protected. As a result, companies wishing to market their own time-released bupropion generics have had to use or develop types of tablets different from those sold as Wellbutrin XL or SR or obtain a license from the originator. In fact, as of September 2007, many of the time-released generics of Wellbutrin on the market used different tablet technologies.
Different types of tablets can release active ingredient at different rates. This can affect a drug's performance. But the safety and efficacy of generic drugs, unlike original drugs, is not clinically tested. Instead, the FDA relies on data from each manufacturer showing that their generic contains the same ingredient as the original, dissolves at approximately the same rate, and appears in people's blood at about the same levels as with the original product. If the results are within the FDA's limits, the generic is deemed "bioequivalent" to the original drug and can be approved for sale.
However, reviewing the FDA's test requirements, ConsumerLab.com found that generic products are allowed to vary from one another by a fairly wide range. For example, a twice-a-day (SR) version of bupropion is permitted to release anywhere from 60% to 85% of its ingredient after four hours into a dissolution test. At the completion of such a test (which only runs eight hours), a product could be as little as 80% dissolved or over 100% dissolved and still be considered bioequivalent. ConsumerLab also discovered that the acceptable limits for once-a-day (XL) versions have been blacked-out or deleted in documents on the FDA website.
Update: In a major reversal, the FDA declared that two generic versions of bupropion hydrochloride XL 300 are not bioequivalent to Wellbutrin XL 300 mg. These products were on the market for many years. For details, see the Update at the top of the full report.