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.
Over the last 1
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 a day would take the highest dose of recalled batches daily for four years, the agency estimates there would be another cancer case on their lives.
Torrent said only batches with NMBA will be recalled that are beyond what the FDA considers acceptable for daily use. Overall, Torrent has recalled more than 300 lots of blood pressure pills since the summer of 2018. He is one of a dozen drug manufacturers who have recalled blood pressure products 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.
Zantac manufacturer Sanofi said it has 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.
"Multiple Systemic Systemic Issue"
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 to be a continuing threat to public health designated.
The FDA should consider that any generic manufacturer who has experienced these issues will have to stop production until the issues are resolved, according to Adam Garber, Consumer Surveillance at the US PIRG.
Just before production is cut short, the FDA should "inspect every 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 discontinue the sale of versions that contain these contaminants," said Garber, who said he did not advocate people taking it of cardiac medications, as this would pose potential health risks.
An FDA spokesperson said the agency identified numerous alternative versions and offered the public an official list of affected products and contaminated products for review.
"Based on our recent reviews, including lab testing, the agency identified 43 ARB drugs that were found to contain no nitrosamine contaminants," the spokesperson said via email. "As we continue our evaluations and companies continue to produce ARBs without nitrosamine contaminants to replenish supply in the US, we expect this number to increase."
"Because 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.