Nearly eight in 10 prescriptions filled in the United States are generic medicines, and the number is expected to increase through 2015 as patents expire on a number of popular drugs. Extended time-release medicines represent a growing portion of generic medications.
It’s noteworthy that federal drug regulators announced the Food and Drug Administration will be looking more closely at the way pharmaceutical companies make extended time-release generic medications, as reported in a Nov. 1 article in The New York Times.
Generic medicines are required to have the same active ingredient and dosage form as the brand-name medication. But the mechanism for releasing the medicine into a user’s body can be different.
The FDA decided to give closer scrutiny to how generic time release medications are manufactured after finding that one such generic didn’t work as well as its brand-name counterpart. In October, the FDA said in a drug safety announcement that a 300-milligram dose of Budeprion, a generic antidepressant, was not equivalent to a 300-milligram dose of the name-brand antidepressant Wellbutrin XL. Soon after Budeprion XL 300 mg was approved in 2006, patients who switched from Wellbutrin to the generic began complaining that their depression had returned.
The FDA conducted its own study after the manufacturer said it couldn’t recruit enough subjects to do the study. The study, published last month, revealed that 300-milligram tablets of Budeprion XL failed to release the active ingredient buproprion into the blood at the same rate and to the same extent as Wellbutrin. The FDA has asked the manufacturers of four other generic versions of Wellbutrin XL 300 mg to conduct studies to assess whether their products are equivalents of the brand name medication.
Budeprion XL 300, which is manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA, Inc., will be removed from the market, according to the FDA.
If you have questions about the effectiveness of a medication that you are taking, you should talk to your doctor or health care professional. If you suspect that a prescription medication has harmed you or a family member or caused a serious side effect, it’s a good idea to talk to a knowledgeable attorney about unsafe drugs and your legal rights. Patients should be able to count on the fact that the medications they are taking are safe and effective when used as directed. If you’ve suffered a serious side-effect from a medication, you may be entitled to compensation.
The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe drugs and by pharmaceutical manufacturers that put profits ahead of patient safety. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products cause injury. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.