Torrent Pharmaceuticals extends the recall of blood pressure medications possibly affected by a cancer-causing chemical. The expansion is the fifth of Torrent to include widely used losartan potassium tablets sold nationwide. Regulators first moved to withdraw heartwarming drugs with potentially deadly contaminants from store shelves last year.
The polluter behind the latest Torrent download is also the one that prompted Novartis to halt the distribution of generic versions of the popular acid drug earlier in the week.
Torrent on Thursday said he recalled an additional five batches of drugs used to treat hypertension after the discovery in the tablets of a chemical called NMBA (for N-nitroso-N-methyl-4-aminobutyric acid).
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The FDA stated that impurities in common blood pressure pills known as ARB drugs (for drugs blocking angiotensin II receptors) may be the result of chemical reactions occurring during the production or reuse of materials as solvents. .
If 8,000 people take the highest dose of batches downloaded every day for four years, there is likely to be another case of cancer in the lives of those people, the agency estimates.
Torrent stated that he recalled only batches containing NMBA above what the FDA considered acceptable for daily use. In total, Torrent recalled over 300 batches of blood pressure pills as of the summer of 2018. This is among a dozen drug makers who recalled blood pressure medicines manufactured with active ingredients from suppliers in China and India.
Other companies announce recalls include Mylan, Aurobindo Pharma, Camber Pharmaceuticals, Macleods Pharmaceuticals, Legacy Pharmaceuticals, GSMS Inc., WP Westminster Pharmaceuticals, Major Pharmaceuticals, Princeton Pharmaceuticals, Sandoz Novartis and Teva Pharmaceuticals.
While regulators were mostly concerned about the class of hypertension medicines known as ARBs, last week the FDA and Europe's top regulatory physician said they were reviewing the NDMA levels in Zantac and its generic forms.
Within days, the Sandoz unit of Novartis stated that it was stopping the worldwide distribution of generic versions of Zantac .
Zantac's manufacturer, Sanofi, stated that there were no plans to suspend the distribution or sale of drugs in the US or Europe, citing FDA reports that only traces of NDMA were identified. "We are conducting our own robust investigations to ensure that we continue to meet the highest standards of safety and quality," Sanofi said in a statement.
A "systemic problem" among multiple manufacturers
However, one consumer advocate called on the FDA to step up its efforts, saying it was stopping distribution and even recalling inadequate responses to what advocates called a continuing threat to public health.
The FDA should consider requiring any generic manufacturer who has had these problems to stop production until the problems are resolved, according to Adam Garber, US consumer watchdog PIRG.
In addition to limiting production, the FDA "must inspect every version of this drug because it seems to be a systemic problem and we are talking about multiple manufacturers," Garber told CBS MoneyWatch.
"At this point, we need to look at alternative versions and stop selling versions that have these impurities," said Garber, who emphasized that he does not advocate taking heart medicines, given the potential adverse health risks that would move the waters.
An FDA spokesman stated that the agency had identified a number of alternative versions and was offering an official list of affected and impurity-free products for public review.
"Based on our current evaluations, including laboratory tests, the agency identified 43 ARB drugs that were determined to be free of nitrosamines," the spokesman wrote in a statement. "As we continue our evaluations and as companies continue to produce ARB without nitrosamine impurities to fill US delivery, we expect this figure to increase. "
" As ARBs treat serious medical conditions, the FDA is urging patients to continue taking their current medication until a doctor or pharmacist gave no substitute or other treatment, "the spokesman added.