FDA investigating safety, ‘equivalency’ for generic versions of drugs Wellbutrin, Toprol

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by Jim Orr

The overwhelming majority of medicines prescribed in the United States are generic versions of drugs. Many of us assume these generic drugs are just as safe and just as effective as the brand name version. Oftentimes, they are, but not always.

The bottom line is that a generic drug will be a little different in some way from the original brand name drug and differences can matter—sometimes a great deal. For example, many drugs today employ some sort of extended-release mechanism. The generic version of a drug may include the same active ingredient as the brand name version yet rely on very different extended-release technology.

FDA investigates generic drug Budeprion

The FDA began receiving negative reports regarding the drug Budeprion shortly after it had been approved in December 2006. Budeprion was a generic version of the brand name anti-depressant drug Wellbutrin. The generic was manufactured by Impax and distributed by Teva.

Although Budeprion contained the same active ingredient as Wellbutrin, bupropion hydrochloride, the FDA began receiving reports complaining of either adverse events or lack of an effect after switching from Wellbutrin XL 300 mg to Impax/Teva’s Budeprion XL 300 mg. Nearly half of the patients who reported experiencing a lack of effect or adverse events upon switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg subsequently reported experiencing an improvement in conditions when they resumed their Wellbutrin XL 300 mg regimen.

As negative reports continued, the FDA eventually asked Teva and Impax to conduct a study of people who used the 300 mg dose and had complained of problems. The companies started but then cancelled a study in late 2011, claiming they couldn’t recruit enough participants.

In 2010, in light of the public health interest, the FDA decided to sponsor its own bioequivalence study comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg. The results of this study became available in August 2012, and showed that Budeprion XL 300 mg tablets failed to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg. In short, the FDA determined that the generic drug was not “therapeutically equivalent” to the brand name version. As a result, Impax/Teva was forced to remove the drug from the market.

To market a generic drug, a manufacturer needs to demonstrate, among other things, that its product is “bioequivalent” to an FDA-approved reference listed drug. A generic is bioequivalent to a brand name drug if the generic has a similar rate and extent of absorption into the blood of the active ingredient. The FDA accepts drugs as sufficiently “bioequivalent” as long as the generic comes within an accepted range. Critics say the FDA’s range is far too broad and that generics are being approved that should not be approved.

When it was initially approved, Budeprion XL 300 mg satisfied the applicable FDA standards. However, Budeprion XL 300 mg was not independently tested at all prior to approval. Instead, the FDA allowed the manufacture to extrapolate from data for the 100 mg dose of the drug. Testing only one dose of a drug undoubtedly helps a manufacturer save time and money. Of course, we know today that such an approach did not work for Budeprion.

FDA investigates generic drug Metoprolol

The FDA is now investigating concerns over the equivalency of Metoprolol, the generic of the brand name high blood pressure medicine Toprol XL. With this drug, the generic version makes up about 90 percent of all physicians’ orders for the drug. Generic versions are made by Wockhardt and Dr. Reddy’s Laboratories (both based in India) and by Mylan and Actavis (in the U.S). The FDA is now looking into all of them.

In November of last year, the FDA issued an import alert in November for Wockhardt’s drug plant in India. One of the products the plant made was metoprolol succinate. The FDA cited the facility for unsanitary conditions and for manipulating the results of quality tests.

The recent investigation into the generic blood pressure drug began when a cardiologist expressed concern to the FDA in 2012 that the pills he was prescribing worked inconsistently. The generic versions of Toprol XL have resulted in more than 3,400 adverse reaction reports over effectiveness and side effects.

The FDA has already conducted tests to see if the generics dissolve properly and is apparently seeking to conduct more extensive studies. The agency has requested funding to conduct pharmacokinetic and pharmacodynamic studies of the generic version.

Generics of this drug have faced problems before. In 2008, Novartis AG ’s Sandoz unit took its metoprolol succinate off the market after it recalled more than 6 million bottles in 2008 when it was discovered the product might not meet certain specifications.

There are more than 11,000 FDA-regulated drugs on the market and nearly one hundred more approved each year. If you think the FDA has tested these drugs and determined the drugs are safe and effective before approving them, think again.

FDA approved drugs have actually been tested only by the same drug companies that plan to profit from selling the drugs they test. The FDA does not test the drugs. One more time: the FDA does not test the drugs. You can read more about “The Myth of ‘FDA Approved’ and Drug Safety” here.

Heygood, Orr & Pearson taking on Big Pharma

At Heygood, Orr & Pearson, we believe when a drug company sells a drug or medical device that is dangerous and unsafe they should be held responsible for the damage caused by doing so. We have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to dangerous prescription drugs such as Yaz, Actos, Avandia, and Accutane, we have made it a career priority to hold drug manufacturers accountable and responsible for their actions.

The lawyers at Heygood, Orr & Pearson are trial attorneys in the truest sense. We are as comfortable before a judge and jury as we are drafting a legal brief. In fact, every one of our attorneys has trial experience, ranging from auto accident cases to commercial fraud cases to pharmaceutical liability cases. Our attorneys have tried over 200 cases to verdict and we have achieved verdicts and settlements for our clients totaling more than $200 million. Most importantly, we are all committed to bringing the highest standards of ethics and a passion for justice to every client and every case.

Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us for a free legal consultation to find out more about your legal options.