by Phyllis Vine

The Food and Drug Administration (FDA) has long known that Budeprion XL 300, a generic antidepressant, acts differently than Wellbutrin 300 XL, the patented antidepressant. Yet it has taken no steps to alert consumers or physicians about reports of disturbing side effects from people who have been switched to the generic.

Information posted on the FDA website about generic drugs claim they are identical to their branded counterparts. But independent tests from ConsumerLab in October showed the two dissolve at different rates, with the generic releasing four times faster in the first two hours.

After several requests for an update about the status of their investigation, an FDA spokesperson told MIWatch on Thursday that the “FDA is continuing to evaluate the data regarding generic Wellbutrin. We have not yet released a statement." Nor has the agency posted an announcement on its website.

In an interview on the Larry Mantle radio show (Dec. 19), FDA Director of the Office of Medical Policy in the Center for Drug Evaluation and Research, Bob Temple, said the FDA did not believe the faster action mattered. Temple said, ”having the blood levels come up a little bit sooner—two hours instead of four hours, say—should not interfere with the therapy. In fact, you might even think it would enhance it. “

Patients are finding otherwise. Many have reported adverse reactions -- anxiety, sleeplessness, agitation, crying, sadness, suicidal ideation -- within days of changing from Wellbutrin to Budeprion. When changing back, their symptoms abated. Similar complaints have been noted for the generic form of Zoloft. Both are made by Teva, an Israeli company with a global market and manufacturing plants in nine countries.

Problems widespread
Many patients did not know how widespread the problem was until they started to read about the experience of others on People's Pharmacy, a website where people post questions and comments about medication. It is run by Joe and Terry Graedon, authors and syndicated radio hosts.

Last week, appearing on the Graedon's radio show, FDA medical officer, Dr. Janet Woodcock, said the agency was still looking into the issue. She noted that their "post-marketing safety" is seriously compromised for lack of budget and staffing. Basically, she acknowledged that the watch-dog of the nation’s health relies on patients to volunteer complaints about adverse effects after the product is in the public's hands.

A section of the FDA's website, MedWatch, accepts complaints through a system Woodcock called “spontaneous reporting" -- a seven-page click-through eliciting descriptions of the problems which could range from a rash to the collapse of an artificial or mechanical valve, to side effects as serious as the contemplation of suicide.

With the numbers of drugs coming off-patent, and the push from government and insurance companies to spend less on medication, citizens rely on the FDA to guarantee generics are equivalent. But the quality controls, it seems, are weak.

Please take the time to comment about your experiences (good and bad) when changing from a brand name to a generic drug.

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Generic antidepressant not equal to patented product