Just a few months after one generic version of a popular extended-release blood pressure medication was recalled, a lot of metoprolol succinate from another manufacturer was recalled for the same reason: the drug did not dissolve properly.
The recalled drugs, made by Wockhardt and Dr. Reddy’s Laboratories, both located in India, failed a dissolution test to check the time it takes for the active ingredient in a drug to release into the body. Extended-release formulas pose challenges to generic companies seeking to replicate brand-name extended-release drugs. Brand-name companies hold patents on the way a pill releases the drug, The New York Times explains. So even if the maker of a generic can match the active ingredient once the patent expires, the company must also find a release method that does not infringe on a separate patent.Dr. Harry Lever, a cardiologist at the Cleveland Clinic, had expressed concern about the generics manufactured in India when numerous patients complained of chest pains and other symptoms that disappeared when he switched them to a different generic or to Astra-Zenica’s brand name Toprol XL. Dr. Lever says, “There’s been this assumption that one generic is the same as another. Not in this case.” In a similar case in 2012, the FDA determined that an extended-release generic version of the antidepressant Wellbutrin was not the equivalent of the brand-name product and the agency said it would take a closer look at how well generic companies were making extended-release drugs, according to the Times.
The recalls are among recent safety and quality problems involving generic drugs, in particular those made in India. Wockhardt has been banned from exporting drugs to the United States that were manufactured in two Indian plants where FDA inspectors uncovered serious problems. FDA commissioner, Dr. Margaret A. Hamburg, traveled to India in February to meet with drug makers about the safety of medicines manufactured there, the Times reports.
Generic drugs now account for more than 80 percent of prescriptions written annually in the United States, according to Reuters, and Indian manufacturers are major suppliers. The FDA must assure doctors and patients not only that the generic is equivalent to the brand-name drug in its active ingredients but also that it will release those ingredients into the body at the expected strength.