There is more fallout from tainted losartan API produced in India by Hetero Labs. A week after Torrent recalled more than 100 lots because of an impurity that might cause cancer, Teva has added to the recall with 35 lots of bulk losartan potassium tablets made with the Hetero ingredient. The two recalls will likely deepen shortages of losartan that the FDA has already warned of.
Teva, in an announcement distributed by the FDA, is voluntarily recalling to the consumer level six lots of 25 mg strength and 29 lots of 100 mg strength, all of which it sold to Golden State Medical Supply. It said it was recalled after the FDA determined that six lots of Hetero API contained the impurity—N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)—that was above the acceptable exposure limit.
Teva pointed out that the risk of getting cancer from taking the pills is very small, and following an FDA recommendation, said consumers that have any of the tablets should continue to take them until their doctor or pharmacy can find them an alternative.
Torrent last week recalled 36 lots of losartan potassium tablets USP and 68 lots of losartan potassium/hydrochlorothiazide tablets USP in a variety of dose strengths because of the NMBA contamination. The recall added up to more than 1.07 million bottles.
The sartan drug fiasco began last year when a U.S. drug manufacturer told the FDA it had discovered the impurity N-nitrosodimethylamine (NDMA) in a valsartan active pharmaceutical ingredient made by China’s Zhejiang Huahai Pharmaceutical. After investigating, the agency found contaminants NDMA, NDEA and NMBA, which are considered probable carcinogens, can form through specific and commonly used manufacturing processes.
As the recalls piled up, the FDA this month identified drugs from 40 producers whose levels of the impurities did not exceed acceptable levels. But the discovery of drugs that do has also continued, leading to shortages of valsartan and losartan, common meds used in the treatment of high blood pressure.
In March, the FDA acknowledged there were shortages of losartan and alternatives might not be readily available. In response, it said its scientists believed the risks of stroke or heart attack from consumers not taking their blood pressure medications was greater than their risk of potentially getting cancer. The FDA said patients should continue to take even recalled drugs until their caregiver or pharmacy could find an impurity-free source of the medication.
Around the edges of the mess, the inevitable legal fallout has also been spreading. Last week, a lawyer representing consumers who are suing drugmakers for making or marketing tainted drugs told a federal judge that he expects some 2,000 lawsuits claiming injuries from the adulterated products within the next two years.