The US Food and Drug Administration takes too long to assessthat may contain traces of a known carcinogen. According to a consumer monitoring group.
The FDA announced in March that it would temporarily increase the permitted levels of the chemical in question, nitrosamine, in so-called sartan medicines, while conducting a six-month investigation into their potential toxicity. Since then, the agency has evaluated only 26% of the bloodstream medicines on the market, the US Public Interest Research Group said on Thursday in an analysis of publicly available FDA data.
"Americans expect their blood pressure medicines to treat their condition and not cause cancer," said Adam Garber of the US PIRG. "The FDA has an obligation to follow its own self-imposed safety timetable to ensure that the millions of patients who need these drugs are not exposed to carcinogens," he said.
Nitrosamine is widely used in nature and contains trace amounts in water, vegetables and processed meat. So far, however, the FDA found that in 61
The FDA declined to respond directly to US PIRG concerns on Thursday. His analysis of the potential cancer risks associated with leading blood pressure treatments means that the agency must balance the risk of life-saving drugs that millions of Americans rely on against the potential presence of unsafe nitrosamine levels in these drugs. If, according to current calculations by the FDA, 8,000 patients take the highest dose of one of the most heavily contaminated batches of blood pressure medication over a four-year period, this would lead to another cancer case.
"The FDA says that we think there would be a bigger public health crisis if we remove all [the blood pressure drugs] from the market – and that's a fair bill for them," Garber told CBS MoneyWatch. "But then they have to move faster to make sure that manufacturers do not make medicines that contain cancer-causing chemicals, and they've missed their timetable."
Larry Rossini, an 80-year-old resident of Denver, Colorado, has been relying on losartan for years to treat his high blood pressure. It belongs to the medicines, which were recalled because of a possible connection with cancer. He contacted his pharmacist after he was informed of the possible presence of contaminants and learned that the drugstore had not sold any lots of losartan that had been recalled by the FDA.
"I have a high degree of confidence that the drug I take is safe," he said. "I assume that the risk is much lower and that by then there will be filters from pharmacists and traders that mean we're probably in agreement with the drugs, at least keep my fingers crossed."
Instead of recalling potentially contaminatedthe FDA conducts random sampling to prevent contaminated batches from entering pharmacies.
But according to PIRG, this tactic has proved ineffective. The FDA has issued 14 drug-related drug recalls since March. Some pharmacists also expressed concern about the Agency's drug safety procedures.
"I'm frustrated as a pharmacist because I do not know it's free of contaminants when ordering a product," said Alabama pharmacist Patrick Devreaux to CBS MoneyWatch.
"If there is no guarantee that a manufacturer applies good manufacturing practices and may not have any contaminants in the drug, why does not the FDA simply withdraw the entire drug?" Devreaux added.
Both the agency and the PIRG urge patients to continue their blood pressure medication or talk to their doctors about possible alternatives. Dr. However, Jodi Segal, a professor of medicine at the Johns Hopkins University School of Medicine, said switching to new medicines could be his own challenge.
Mistakes when you switch drugs, "said Segal.