Class action lawsuits have been filed by Kanner & Whiteley along with Milstein Adelman & Kreger in several states against the makers and distributors of the generic version of the anti-depressant Wellbutrin XL called Budeprion XL. The cases allege Budeprion XL is not the same as Wellbutrin XL, even though the label claims the two drugs are identical. Even though Budeprion XL is claimed to be identical to Wellbutrin XL, users of Budeprion XL report they have suffered dangerous side effects, such as seizures, nausea, and insomnia, and have also stopped experiencing the anti-depressive effect of Wellbutrin XL.

The cases claim that Teva Pharmaceuticals, Impax Labratories and Anchen Pharmaceuticals have committed fraud because they knew that Budeprion XL was not identical to Wellbutrin XL, yet marketed and labeled Budeprion XL as the same for financial gain. CLASS ACTION LAWSUITS AGAINST THE MAKERS OF GENERIC WELLBUTRIN XL HAVE BEEN FILED IN MANY STATES

The FDA has received hundreds of complaints whereby patients successfully treated with Wellbutrin XL for years were switched to Budeprion XL and immediately stopped experiencing the anti-depressive effect of the drug.

The parent drug in Wellbutrin XL, bupropion hydrochloride, is biotransformed by multiple enzymes into several metabolites: hydroxybupropion, erthyrobupropion, and threohydrobupropion. Research shows that these metabolites are "pharmacologically active" and significant toward the drug's anti-depressive effect. Teva never bothered to ensure that the ratio of metabolites in Budeprion XL was the same as that in Wellbutrin XL.

Budeprion XL Has More Adverse Side Effects

Many patients switching from Wellbutrin XL report headaches, insomnia, nausea, dizziness, etc.In addition to the different ratio of metabolites, this may be due to the fact that Budeprion XL releases bupropion hydrochloride at a much different rate than Wellbutrin XL. -2006 human testing by the FDA: time to peak plasma concentration for 150-mg Budeprion XL is two hours, for Wellbutrin XL it is five hours.

-October 2007 in vitro testing by Consumerlab.com: 300-mg Budeprion XL releases 34 percent of bupropion in first hour Wellbutrin XL 300-mg only releases 8 percent of bupropion in first hour

-December 2007: Dr. Robert temple, Director of FDA's Office of Medical Policy, admitted in interview that Budeprion XL had a release pattern that was more similar to Wellbutrin IR (instant release) than Wellbutrin XL (extended release).

-December 2007: United States Pharmacopeia officially release information indicating that dissolution of Budeprion XL 300-mg releases between 25-50 percent of bupropion in first two hours, compared to Wellbutrin XL which releases less than 20 percent of drug.

The reason? The pills employ different drug release technologies. Budeprion XL uses a matrix of materials that expands when wet and then breaks apart to release the ingredient. Wellbutrin XL utilizes a membrane through which the ingredient is slowly released while the membrane stays intact. THERE ARE NUMEROUS MISREPRESENTATIONS ON BUDEPRION XL'S LABEL

Doctors don't know why their patients suffer problems under Budeprion XL. This is because of the numerous misrepresentations in the Budeprion XL label which lead physicians to believe the two pills are exactly the same. The following misrepresentations are taken directly from Budeprion XL's label.

Misrepresentation: "Following oral administration of BUDEPRION XL to healthy volunteers, time to peak plasma concentration for bupropion was approximately 5 hours[.]"

Lawsuit Alleges: According to data released by FDA in April 2008 (data provided to FDA by generic manufacturer), the time to peak plasma concentration for Budeprion XL was actually two hours, not five.

Misrepresentation: "Food did not affect the Cmax...(maximum total concentration) of bupropion."

Lawsuit Alleges: "April 2008 FDA reports that, when taken with food, more drug is absorbed with Budeprion XL than with Wellbutrin XL."

Misrepresentation: "In a study comparing 14 day dosing with BUDEPRION XL tablets 300 mg once daily to the immediate release formulation...equivalence was demonstrated for peak plasma concentration[.]"

Lawsuit Alleges: April 2008 FDA report indicates no such studies were ever done. In fact, FDA reported that 300-mg studies were never done in humans due to the increased risk of seizures.

Misrepresentation: "In humans, peak plasma concentrations [of the metabolites] occur approximately 7 hours after administration of BUDEPRION XL[.]"

Lawsuit Alleges: Teva never studied the peak plasma of the metabolites for Budeprion XL.

In addition to these misrepresentations, Teva possesses relevant information that it chooses not to disclose to doctors regarding the release rates of Budeprion XL. Thus uninformed Doctors cannot adequately treat their patient's condition and address side effects the patient may be experiencing.