Recall of more pills for blood pressure compared to carcinogenic chemicals

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Torrent Pharmaceuticals is expanding the recall of high blood pressure medications that may be contaminated with a carcinogenic chemical. This extension is the fifth of Torrent and concerns widely used losartan potassium tablets sold throughout the country. Regulators began by removing heart drugs containing potentially deadly contaminants from stores last year.

The contaminant behind the latest Torrent recall is also the same one that prompted Novartis to suspend distribution of generic versions of the Zantac heartburn drug earlier in the week.

Torrent announced Thursday that it was recalling five other batches of drugs used to treat hypertension after the discovery in tablets of a chemical called NMBA (for N-Nitroso-N Acid) -methyl-4-aminobutyric).

Over the last 14 months, the US Food and Drug Administration has been overseeing a series of recalls for a type of generic blood pressure drug produced in China and India and contaminated with NMBA, NDMA (N-nitrosodimethylamine) or NDEA (N -nitrosodiéthylamine).

The FDA has indicated that impurities contained in generic blood pressure pills known as ARA medications (Angiotensin II Receptor Antagonists) could result from chemical reactions that occurred during the manufacturing process or the reuse of substances. such as solvents.

If 8,000 people took the highest dose of recalled batches every day for four years, there would likely be one more case of cancer during their lifetime, the agency said.

Torrent said that recall of lots containing NMBA exceeded 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. It is part of a dozen drug makers who have recalled blood pressure medications made from ### ## # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # Active ingredients from suppliers in China and India.

Mylan, Aurobindo Pharma, Camber Pharmaceuticals, Macleods Pharmaceuticals, Legacy Pharmaceuticals, GSMS Inc., WP Westminster Pharmaceuticals, Leading Pharmaceuticals, Prinston Pharmaceuticals, Sandoz Novartis and Teva Pharmaceuticals are also announcing recalls.

While regulators were primarily concerned about the class of medications for hypertension known as ARB, the FDA and the leading drug regulator in Europe said they were studying levels of NDMA in Zantac and its generic forms.

In a few days, the Novartis Sandoz Unit stated that it was stop global distribution of generic versions of Zantac.

Zantac's manufacturer, Sanofi, has stated that it has no intention to suspend the distribution or sale of the drug in the US or Europe, citing FDA reports that only trace amounts of NDMA had been identified. "We are conducting extensive investigations ourselves to ensure we continue to meet the highest quality, safety and quality standards," Sanofi said in a statement.

"Systemic problem" between several manufacturers

A consumer advocate, however, called on the FDA to redouble efforts, pointing out that stoppages and even recalls were not enough answers to what he called a permanent threat to public health .

The FDA should consider requiring any generic manufacturer that has had these problems to shut down production until these issues are resolved, according to Adam Garber, the US PIRG consumer monitoring agency.

Unless cutting production, the FDA "should inspect every version of this drug because it seems to be a systemic problem and several manufacturers we're talking about," Garber told CBS MoneyWatch.

"At this point, we should consider other versions and stop selling versions containing these impurities," said Garber, who pointed out that he was not advocating that heart medications cease, because potential health risks that result. imply.

A spokesman for the FDA said the agency had identified many alternative versions and offered the public an official list of affected products and products without impurities.

"Based on our current assessments, including laboratory tests, the agency has identified 43 ARA-based drugs that have been identified as not containing nitrosamine impurities," emailed to the spokesperson. "As we continue our assessments and companies continue to manufacture nitrosamine-free ARBs to replenish the US supply, we expect this number to increase."

"Because ARAs treat serious diseases, the FDA encourages patients to continue taking their current medication until a doctor or pharmacist offers them alternative treatment or another treatment option." added the spokesperson.