Torrent Pharmaceuticals has expanded its losartan recall for a fifth time, after a potentially cancer-causing chemical turned up in more batches of the heart and blood pressure medication.
The U.S. Food & Drug Administration (FDA) posted details of the recall on its website last Thursday. The latest expansion includes three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets.
According to the agency, the recalled lots contain nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA.
Since last July, dozens of generic drug makers around the world have recalled their losartan, valsartan, and irbesartan products due to the presence of NMBA and other cancer-causing nitrosamines in active pharmaceutical ingredients sourced from suppliers in China and India.
The recalled medications belong to a drug class called angiotensin II receptor blockers (ARBs) and are indicated to treat heart failure and high blood pressure.
The ongoing recalls don’t include all generic ARBs currently on the market. To determine if a specific medication has been recalled, consumers should refer the FDA website or check with their doctor or pharmacy.
Consumers using any medication included in a valsartan, irbesartan, or losartan recall should contact their healthcare provider for a replacement. However, they should not stop using the drug until they have obtained a replacement, as stopping treatment entirely could result in dangerous, and even deadly, heart or blood pressure events.
More than 130 valsartan lawsuits filed in connection with the recalls are currently undergoing coordinated pretrial proceedings in the U.S. District Court, District of New Jersey. The cases include personal injury claims for cancer, as well as class action lawsuits that seek economic damages for consumers who purchased recalled valsartan products.
The federal litigation does not include any lawsuits associated with the irbesartan or losartan recall. However, a group of plaintiffs recently requested that the U.S. Judicial Panel for Multidistrict Litigation expand the proceeding to include those claims as well.
Legal experts have predicted that the litigation involving contaminated ARBs could eventually grow to include thousands of cases.