Torrent Pharmaceuticals expands the recall of blood pressure medicines that may be contaminated with a carcinogenic chemical. The expansion is the fifth of Torrent, which includes widespread losartan potassium tablets being sold nationwide. The regulators for the first time withdrew heart medicines containing potentially deadly contaminants from the shelves last year.
The pollutant behind the last torrent recall is also the same one that prompted Novartis to discontinue the distribution of generic Zantac desugar at the beginning of the week.
Torrent said Thursday he had recalled another five batches of drug for the treatment of high blood pressure after the discovery of a chemical called NMBA (for N-nitroso-N-methyl-4-aminobutyric acid) in tablets.
The US Food and Drug Administration has conducted a series of reviews over the last 14 months on a generic type of generic blood pressure medication made in China and India using NMBA, NDMA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine) are contaminated.
The FDA has indicated the impurities in the generic blood pressure pills So-called ARB drugs (for angiotensin II receptor blocker drugs) may be the result of chemical reactions that occur during the manufacturing process or in the reuse of materials such as solvents ,
If 8,000 people were to take the highest dose of recalled batches daily for four years, the agency estimates that there would likely be another cancer case on their lives.
Torrent said it would only recall batches that contained NMBA above what the FDA considered acceptable for daily use. Overall, Torrent has recalled more than 300 lots of blood pressure pills since the summer of 2018. It is one of a dozen drug companies that have recalled blood pressure medicines made with ingredients from suppliers in China and India.
Other companies announce this Callbacks include Mylan, Aurobindo Pharma, Camber Pharmaceuticals, Macleods Pharmaceuticals, Legacy Pharmaceuticals, GSMS Inc., WP Westminster Pharmaceuticals, Major Pharmaceuticals, Prinston Pharmaceuticals, Sandoz Novartis and Teva Pharmaceuticals.
While regulators were primarily concerned about the class of high blood pressure medicines known as ARBs, the FDA and Europe's leading regulator last week said they were reviewing the NDMA scores in Zantac and its generic forms was to stop the worldwide spread of generic versions of Zantac .
Zantac maker, Sanofi, said it had no plans to stop distributing or selling the drugs in the US or Europe, and cited FDA reports that only trace amounts of NDMA were identified. "We conduct our own reliable investigations to ensure that we continue to meet the highest safety and quality standards," Sanofi said in a statement.
"Systemic problem" among multiple manufacturers
A consumer advocate, however, called on the FDA to step up its efforts, saying that distribution stops and even recalls were inadequate responses to what the advocate considered a continuing public health threat designated.
The FDA should consider committing a generic company that had these issues to cease production until the issues are resolved, said Adam Garber, consumer watchdog for the US PIRG.
On the verge of curbing production, the FDA should "review any version of this drug, as it appears to be a systemic problem and multiple manufacturers," Garber told CBS MoneyWatch.
At this point, we should look for alternative versions and stop selling the versions that contain these contaminants, "said Garber, who emphasized that he did not advocate that people taking heart medicines stop because of potential health problems
An FDA spokesperson said the agency has identified numerous alternative versions and is offering the public an official list of affected products and products without contaminants for review.
"Based on ours In recent reviews, including lab tests, the agency has identified 43 ARB drugs that have been found to contain no nitrosamine contaminants, "the spokesperson said via email." As we continue our ratings and companies continue to use ARBs without Produce nitrosamine contaminants to replenish supply in the US "Since ARBs treat serious illnesses, the FDA urges patients to take their current medicines until a doctor or pharmacist offers a replacement or other treatment option."
the spokesman added.