In a bid to alleviate shortages stemming from ongoing blood pressure drug recalls, the U.S. Food & Drug Administration (FDA) has approved a new generic version of valsartan.
Valsartan is the generic name for Diovan, an angiotensin II receptor blocker (ARB) that treats heart failure and high blood pressure.
The medication is among several ARBs recalled by dozens of generic drug makers since last June, when cancer-causing chemicals were detected in active pharmaceutical ingredient supplied by two overseas manufacturers. In addition to single-ingredient valsartan tablets, these ongoing recalls include:
In addition to the United States, regulators in 22 other countries, including Canada, Germany, and Poland, have pulled generic versions of valsartan and other ARBs from the market.
The blood pressure drug recalls have resulted in a shortage of these vital medications. Generic drug makers lucky enough to escape the recalls have also taken the opportunity to raise prices on their ARBs by as much as 496%.
The FDA announced the approval of Alkem Laboratories Ltd.’s valsartan on March 12th. According to a press release published that day, the agency prioritized the drug’s review in light of the continuing ARB shortage.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” said FDA Commissioner Scott Gottlieb, M.D.
Among other things, the FDA indicated that it had evaluated the Indian drug maker’s manufacturing and testing procedures to ensure its valsartan is free from the impurities found in other generic ARBs.
The impurities at the center of the generic blood pressure drug recalls were apparently byproducts of a manufacturing method utilized by China-based Zhejiang Huahai and Hetero Labs of India. That particular mode of production had been in use since 2014, so tainted medications were likely in circulation for at least that long.
The FDA continues to update its lists of recalled valsartan, losartan and irbesartan products. Patients who take generic ARBs should check these lists periodically to ensure their medication hasn’t been recalled.
Individuals with a recalled ARB should contact their doctor or pharmacy for a replacement. However, it’s important that they continue taking the medication until the new drug is in their possession, as stopping treatment could lead to dangerous blood pressure spikes and other life-threatening complications.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation centralized all federally-filed valsartan lawsuits related to the recent blood pressure drug recalls before a single judge in the U.S. District Court, District of New Jersey.
Just over 40 cases were pending in that proceeding as of March 15th. The litigation consists of both class action lawsuits for economic damages incurred by consumers who allegedly purchased recalled valsartan, as well as personal injury claims filed on behalf of individuals who purportedly developed cancer due to their use of tainted medications.
According to a Case Management Order dated February 25th, the federal valsartan litigation will convene an Initial Conference on March 21st at 2:00 p.m.