Teva's Budeprion XL Will Get Another Safety And Efficacy Review By FDA

FDA To Collaborate With Complaining Patients On Study Of Reported Problems With This Generic Version Of Antidepressant Wellbutrin XL

(Posted by Tom Lamb at DrugInjuryWatch.com)

By means of a September 23, 2008 Wall Street Journal (WSJ) article, "Wellbutrin Generic to Get New Review", we learned that the FDA is going to re-visit the issues of whether Budeprion XL -- which is made by Impax Laboratories Inc. and distributed by Teva Pharmaceutical Industries Ltd. -- is as safe and effective as Wellbutrin XL -- made by Canada's Biovail Corp. and sold by GlaxoSmithKline PLC.

From the September 23 WSJ article by Andy Georgiades:

Five months after declaring a generic version of antidepressant Wellbutrin XL safe, the U.S. Food and Drug Administration says it is prepared to conduct a human trial to get to the bottom of consumer complaints about the drug....

More than 100 complaints about the drug were filed with the FDA between December 2006 and the end of this January. Among the most common complaints were that the drug was ineffective or aggravated the condition, or caused nausea, anxiety or headache.

This past summer, [Joe Graedon, a pharmacologist and co-founder of the People's Pharmacy] and others were granted a meeting with senior officials from the FDA's Center for Drug Evaluation and Research.

Mr. Graedon said there was a "consensus" by the end of the meeting that the two sides could collaborate on a study that would involve patients who reported problems with the generic after taking the branded version. But he can't begin a recruitment effort until he is given the details of the study design, and he is still waiting to hear from the FDA on that.

This September 2008 WSJ article about generic Wellbutrin reminded me of a man who contacted me in mid-August 2008 regarding an "extreme reaction" -- he said the ultimate diagnosis was septic shock -- which he had within an hour of ingesting his first dose of Budeprion XL.  Taken to the ER, he was put into the Intensive Care Unit (ICU) for several days, and was hospitalized for more than a week until his condition stabilized.

After taking Wellbutrin XL for years without any problem, this man could not understand why Budeprion, which was "only" the generic version of Wellbutrin, would produce this suspected (by his doctors) serious side effect.

Then he found online this article, "Are Generic Drugs Safe?", by Joe Graedon, MS, and Teresa Graedon, PhD; it was published originally in the February 2008 edition of Prevention magazine, which he forwarded to me.

In relevant part, from this February 2008 Preventionarticle by the Graedons:

On March 20, 2007, we contacted the FDA with our concerns; both Robert J. Temple, MD, director of the Office of Medical Policy at the Center for Drug Evaluation and Research, and Gary J. Buehler, RPh, director of the Office of Generic Drugs, told us that the agency would look into it. But the FDA moves slowly, and we were anxious to get to the bottom of this, so we teamed up with ConsumerLab.com to take a close look at Wellbutrin XL 300 and its equivalent, Budeprion XL 300, as well as two generics for sustained-release Wellbutrin. (Most generics go by the name of the active ingredient--in this case, bupropion hydrochloride. But some, like Budeprion, are given distinctive names.) ConsumerLab.com bought samples of each drug to test, using two labs to double-check the results.

You can read about what was found-out by the ConsumerLab.com testing team when you read the Prevention article, which I recommend if you are truly interested in this subject.

We will watch for more about the FDA study comparing Budeprion to Wellbutrin in terms of safety and efficacy, as well as continue to monitor other emerging generic drug issues such as quality control, good manufacturing practices (GMP), and the like.

It seems -- from Actavis Digitek pills and Ethex morphine pills being double-the-intended-dose in some instances, to this current alleged problem with Budeprion -- we should not blindly accepted the "pitch" from health insurance companies that the generic drugs they want you to take, now, are just as good as the brand name medications that they switched you from for cost reasons.

Comments

[Tom Lamb]

Eva:

After hearing reports like yours about Budeprion not serving as an adequate generic substitution for Wellbutrin, I am anxious to see the FDA report on this drug efficacy and safety issue.

I appreciate you sharing your experience with us, I hope you keep reading Drug Injury Watch.

Tom Lamb

[Eva]

About a year ago, my pharmacist substituted the generic budeprion for my Wellbutrin XL. It was awful. I was anxious, disoriented, and really down in the dumps. The Wellbutrin is three times the cost, but my sanity well worth the price.

[Tom Lamb]

Sherry:

The FDA is going to conduct a study about the efficacy of Budeprion in terms of it being an adequate generic substitution for Wellbutrin. We will watch for and report the results.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Sherry Alexander]

My prescription was for Welbutrin and I was given BUDEPRION as the generic drug. I have been taking it for several weeks. I have had increasing depression during this time which prompted me to look it up to see if it was the same as Welbutrin. Believe me it is not. Beside the fact that it does not help my depression, I have had increasing sleeplessness, waking at 2 or 3 AM and not being able to go back to sleep.