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U.S. PIRG says FDA is moving too slowly to assess toxicity for blood pressure medication



The US Food and Drug Administration is taking too long to assess the safety of blood pressure drugs that may contain traces of a known carcinogen, which may endanger patients who have long relied on the drug to treat hypertension. , according to a consumer watchdog group.

In March, the FDA said it would temporarily increase the permissible levels of the chemical in question, called nitrosamine, in so-called sartan drugs while conducting a six-month study of their potential toxicity. Since then, the agency has evaluated only 26% of blood pressure drugs on the market, says U.S. Public Interest Research Group Thursday in an analysis of publicly available FDA data.

"Americans expect their blood pressure medication to treat their condition, not cause cancer," said Adam Garber of the U.S. PIRG. "The FDA has an obligation to meet its own self-imposed safety timeline to ensure that the millions of patients who need these drugs are not exposed to carcinogens," he said.

Nitrosamine is common in nature, with trace amounts present. in water, vegetables and processed meat. To date, however, the FDA has found nitrosamine at levels that exceed the permitted temporary level in 61

% of certain batches of the drugs it has tested, according to US PIRG.

FDA expands recall of blood pressure medication valsartan due to likely carcinogenic

FDA refused to respond directly to US PIRG's concerns Thursday. Its investigation of potential cancer risks surrounding leading blood pressure treatments means that the agency must balance the risk of receiving life-saving medicines that millions of Americans rely on for the possible presence of unsafe levels of nitrosamine in these drugs. According to the FDA's current estimates, if 8,000 patients were to take the highest dose of one of the most contaminated blood pressure medication in four years, it would result in another case of cancer.

"The FDA says we think it would be a major public health crisis if we pull all [the blood pressure drugs] out of the market – and that's a fair calculation for them to do," Garber told CBS MoneyWatch. "But then they have to move. faster to make sure manufacturers don't create drugs that have carcinogenic chemicals, and they have missed their timeline to do so. "

Larry Rossini, an 80-year-old Denver, Colorado resident, has relied on Losartan to treat its high blood pressure It is among the drugs that have been the subject of recall about a possible link to cancer He contacted his pharmacist after learning about the possible presence of contaminants and was told that the pharmacy had not sold any batches of Losartan recalled by the FDA.

"I have a high degree of confidence that the medicine I take is safe," he said. "I think there is a lot less risk and that when it comes to us there will be filters in place by pharmacists and distributors which means we are probably okay with the medicine. My fingers are at least crossed. "

Blood Pressure Medicine Losartan recalled

Instead of recalling potentially contaminated batches of blood pressure drugs the FDA conducts site inspections by testing randomized samples of drugs to test for drug samples. parties reach pharmacy.

But that tactic has proven to be ineffective, according to PIRG.The FDA has issued 14 recalls for blood pressure drugs since March, some pharmacists have also expressed concern over the agency's process to ensure that the drugs are safe. [19659002] "I am frustrated as a pharmacist for ordering a product I do not know that it is free from contamination," Alabama pharmacist Patrick Devreaux told CBS MoneyWatch.

"If there is no guarantee that a manufacturer uses good manufacturing practices and can't have a contaminant in the drug, why doesn't the FDA just withdraw the entire drug? " Devreaux added.

Both the agency and PIRG encourage patients to continue taking their blood pressure medication or talk to their doctors about possible alternatives. But Dr. Jodi Segal, professor of medicine at Johns Hopkins University School of Medicine, said switching patients to new drugs can offer their own challenges.

"It confuses patients and scares them, and there is also a risk of medical malfunction when you change drugs, Segal said.


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