The U.S. Food and Drug Administration (FDA) has announced that broad research will be conducted on blood pressure medications following thousands of complaints received from physicians and patients about the drugs.
About 40 million prescriptions are written each year for the medications, so-called “copied” versions of the extended release AstraZeneca PLc Toprol SL. These make up most—90 percent—of the prescriptions written, according to Bloomberg News. Other versions include medications manufactured by Wockhardt Ltd. and Dr. Reddy’s Laboratories Ltd., which is based in India, and Mylan Inc. and Actavis Plc, which are based in the United States. The medication is generically known as metoprolol succinate.
Reports indicate efficacy issues and troubling side effects, according to a review of over 3,400 adverse incident reports by Bloomberg News. Although reports do not generally identify manufacturers, the U.S. Food and Drug Administration (FDA) will be looking at if the copied versions represent chemically equivalent versions to the original drug, according to the funding request. “The FDA will continue to monitor and review available safety and other information related to metoprolol succinate extended release products and take any further action as appropriate,” said Sandy Walsh, a spokeswoman, in an e-mail to Bloomberg News.
The new plan extends $20 million to the FDA testing program implemented in September. Early testing found that generic versions of the drugs dissolved properly and the FDA is now contracting with third-party researchers to continue with deeper research, said Walsh. The FDA also re-evaluated criteria for generic product approval, she added, according to Bloomberg News.
Wockhardt, which is located in India, is the seventh-largest drug maker, by revenue. Wockhardt also controlled about 26 percent of the U.S. market for metoprolol succinate, which was manufactured at its Chikalthana, India plant. In late 2013, the facility was, along with 20 other plants based in India, banned from sending its medications to the U.S. since early last year, according to Bloomberg News. Among the FDA’s citations are unsanitary conditions and workers manipulating tests on quality.
The FDA’s current testing program involves research on 19 generic drug copies including immune-suppressing and inhaled allergy drugs. Some studies are expected to be completed by this September, while others may take years, the FDA indicated. The new research into metoprolol succinate is scheduled to begin this September and will likely take about three years to complete, Bloomberg News reported.
The research into metoprolol succinate began when a cardiologist at the Cleveland Clinic, Harry Lever, advised the agency in 2012 that he was seeing inconsistencies in the medications he was prescribing. In February, he talked about these generic drug concerns at a Congressional hearing, wrote Bloomberg News.
Novartis AG’s Sandoz unit recalled more than 6 million bottles of its metoprolol succinate, taking it off the market in 2008 over issues with the drug not meeting some specifications, according to the FDA. Of note, generic drugs are not required to be identically copied to their branded versions when it comes to extended-release technology.