Federal regulators announced that extensive research on blood pressure medications will be conducted following thousands of complaints. Federal regulators announced that extensive research on blood pressure medications will be conducted following thousands of complaints made by physicians and patients.
Some 40 million prescriptions are written annually for the drugs, with “copied” versions of the extended release version of AstraZeneca PLC’s Toprol SL comprising most—90 percent—of the prescriptions written, according to Bloomberg News. Other versions include those manufactured by Wockhardt Ltd. and Dr. Reddy’s Laboratories Ltd., which are India-based, and Mylan Inc. and Actavis PLC, which are based in the United States. The medication is generically known as metoprolol succinate.
Reports mention both lack of efficacy and worrisome side effects
Reports mention both a lack of efficacy and worrisome side effects, according to a review of over 3,400 adverse incident reports by Bloomberg News. Reports do not typically identify manufacturers; however, U.S. Food and Drug Administration (FDA) will be specifically looking at if the copied versions are chemically equivalent 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 is an extension of a $20 million FDA testing program that was implemented in September. Early tests reveal that the generic versions of the drugs dissolved properly. The FDA is now contracting with third-party researchers to continue with more extensive research, said Walsh. The FDA has re-evaluated criteria for generic product approval as well, she added, according to Bloomberg News.
Wockhardt is the seventh-largest drug maker
Wockhardt is the seventh-largest drug maker, by revenue, in India and had controlled about 26 percent of the U.S. market for metoprolol succinate manufactured at its Chikalthana, India plant. In late 2013, the facility was banned from sending drugs to the U.S., with 20 other India-based plants since early last year, according to Bloomberg News. The FDA cited unsanitary conditions, as well as workers who were manipulating tests on quality.
The current testing program involves research on 19 generic copies of drugs that include immune-suppressing and inhaled allergy medications. Some of the studies are expected to be completed by this September; others may take years, the FDA indicated. The new research into metoprolol succinate will begin this September and may take about three years, Bloomberg News reported.
The research into metoprolol succinate began when a cardiologist at the Cleveland Clinic, Harry Lever, expressed issues to the agency in 2012 that he was seeing inconsistencies in the medications he was prescribing. In February, he discussed 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
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 product not meeting some specifications, according to the FDA. Of note, generic drugs do not need to be identically copied to the branded versions regarding extended-release technology.