Generic Drugs: Dangerous Differences?

The accounts are disturbing. Patients taking a popular antidepressant who switched to its generic equivalent expected the same effects.

"I got switched to a different generic of Wellbutrin XL, and my life was destroyed," reads one account submitted to the Web site of the syndicated newspaper column The People's Pharmacy. "I became suicidal. I had not been this depressed in years. ... My experience with the generic destroyed everything in my life that was important to me."

"For the first few months, I got the Wellbutrin, then my insurance company said I had to get the generic," reads a recent post on the ConsumerLab.com Web site. "I didn't think it was a problem; I'd used generics before.

"Within weeks my depression reoccurred. ... By April I was suicidal. Following a suicide attempt, I spent one week in a mental hospital. I will never take the generic [for] Wellbutrin again."

Until last week, such reports from consumers were by and large the only hints that the generic version of the antidepressant drug known as bupropion might not function in the same way as the brand-name product it was formulated to represent.

However, a report released last week by the independent testing organization ConsumerLab.com has doctors divided in the debate over whether the cheaper generic versions of the drug -- as well as of many other prescription drugs -- are as safe and effective as their brand-name counterparts.

The findings could raise concerns for patients who, in trying to save money, switch to cheaper generic versions of the drugs they need.

"I think there is little doubt that our results, along with the dramatic and mounting consumer complaints, justify cautioning consumers of a potential difference," said Dr. Tod Cooperman, president of ConsumerLab.com, based in Westchester, N.Y.

The research ConsumerLab.com conducted -- which measured how much of the active ingredient was released from pills as they dissolved over the course of several hours -- suggested that while the active ingredient in the generic Budeprion XL 300 mg and brand-name Wellbutrin XL 300 mg products were the same, the rate at which it was released was differed.

Dr. Harold Koenig, associate professor of psychiatry and medicine at Duke University, said the discovery of any type of difference in a generic version of an antidepressant is "very worrisome."

"I have had many patients complain that generic versions of drugs were not effective or had different side effects than brand-name drugs," Koenig said. "I've repeatedly reassured them that the generic and brand forms of the drug were identical in every way.

"If this turns out not to be the case, then many patients may be vindicated in their experiences and us psychiatrists proved wrong."

But not all doctors and pharmacy experts agree that the findings are a cause for alarm -- particularly since the tests conducted by ConsumerLab.com were not conducted on human subjects.

"The FDA already looked into this and concluded that the generic version of the drug was equivalent to the brand name," said Dr. Sidney Wolfe, director of the Washington-D.C.-based Public Citizen's Health Research Group. "The FDA requirements include measuring blood levels in patients using the drug, the only reliable way to examine bioequivalence. ConsumerLab.com looked, I believe, only at test tube dissolution, which is not sufficient."

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