FDA's investigation of generic antidepresssant called inadequate by ConsumerLab.com and The People's Pharmacy

WHITE PLAINS, NEW YORK AND DURHAM, NORTH CAROLINA — APRIL 16, 2008 — After waiting more than six months for results of the FDA's investigation of a generic version of Wellbutrin XL 300 (Budeprion XL 300), ConsumerLab.com and The People's Pharmacy expressed disappointment with FDA's report issued this afternoon and considered the report to be inadequate.  The FDA review was undertaken in response to numerous consumer complaints about the drug, including those posted at www.PeoplesPharmacy.com, and a report by ConsumerLab.com in October showing the once-a-day product to dissolve more rapidly than the original drug.  Budeprion XL 300 is distributed by Teva Pharmaceuticals and manufactured by Impax Laboratories.

In a news release today about its report, the FDA concluded that it "... considers Teva's generic drug to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug."

"For the FDA to say that it has reviewed the safety and efficacy of this product is not correct," said Tod Cooperman, MD, President of ConsumerLab.com. "No safety or efficacy testing of this novel 300 milligram formulation appears to have been conducted nor reviewed by the FDA.  In fact, the FDA does not have bioequivalence data for this product."  Joe Graedon of The People's Pharmacy added, "The FDA is misleading the public by publishing a positive review which actually provides no data for the 300 milligram product about which people are complaining."

The FDA report entitled "Review of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" only provides data for a 150 milligram version of the Budeprion XL.  A graph shows that blood levels rose more rapidly with it than with the original, consistent with ConsumerLab.com's dissolution test findings with the 300 milligram product.  In fact, Dr. Robert Temple, a high-ranking FDA official, noted in an interview on Southern California Public Radio in December that this drug releases its active ingredient more like a twice-a-day version (Wellbutrin SR) than the once-a-day version (Wellbutrin XL) to which it is supposed to be equivalent.

The FDA report summarizes studies showing that depression can recur while using antidepressants and indicates that such recurrences "offer a fully satisfactory explanation for why some patients experience worsening of their depression following a switch to a generic product."

Joe Graedon of The People's Pharmacy said, "We are disappointed that the FDA has dismissed hundreds of case reports linking the generic version to therapeutic failure and adverse reactions such as headache, tremor, nausea, irritability and insomnia. These are classic complaints of excessive levels of bupropion, the active ingredient. Some patients have become so severely depressed on the generic that they have considered suicide.

Hundreds of complaints with Budeprion XL 300 are now found on the PeoplesPharmacy.com website.  ConsumerLab.com continues to research the equivalence of other generic drugs with reported problems.  It reported last month that generic versions of anti-hypertensive Toprol XL do not all dissolve like the original and vary in composition.  Consumers using generic versions have reported increased blood pressure and side-effects not typical with Toprol XL.

ConsumerLab.com's Dr. Cooperman noted that "Good generics can be a godsend for consumers.  But the FDA should be taking a much more cautious approach with generic drugs because they are not tested for safety or efficacy.  A consumer will be the first to know if there is a problem — not the manufacturer and not the FDA."ConsumerLab.com and The People's Pharmacy continue to urge the FDA to require that the following information be provided for every generic drug:

• Inclusion in package inserts of dissolution and bioequivalence results, showing how these differ from the original drug.
• Inclusion in consumer literature of a list highlighting ingredients not found in the original drug.
• Publicly accessible reports of adverse events not typical of the original drug.

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, supplements, and generic drugs are available at www.consumerlab.com.  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 run PeoplesPharmacy.com and 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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