Several popular drugs used to treat high blood pressure may be contaminated with cancer-causing chemicals, the Food and Drug Administration (FDA) warned on Thursday.
The agency announced the discovery of a potentially carcinogenic ingredient in valsartan in July, after the manufacturer signaled it in June.
Camber Pharmaceuticdals voluntarily withdrew the pills on August 9 after a probable carcinogen known as N-nitrosodimethylamine (NDMA).
The FDA still describes the chemical as only "trace" amounts, but has now discovered that many other manufacturers probably repackaged and sold generic valsartan under other names.
It is believed that about 8,000 patients are at risk for the affected drugs, but the FDA estimates that the incident will not increase the overall cancer rate in the US. UU In more than one case annually.
Valsartan and common blood pressure medications sold under other names but containing valsartan are under FDA investigation after a carcinogen was discovered in the drug
Nearly half of all Americans, more than 100 million, have high blood pressure, and the condition leads to the death of thousands every year.
Medicines to keep blood pressure under control are vital, but for several thousand people in the US UU (And more, abroad), the drugs meant to keep them alive could have been slowly corrupting their cancer cells for years.
The chemical detected in valsartan, NDMA, is considered a "probable carcinogen" for humans.
The pills with the highest dose of valsartan sold in the United States (320 mg) had higher levels of NDMA than the FDA considers acceptable.
Only the 8,000 people who according to the FDA took this dose daily for four years are likely to be affected.
Approximately one in three people will get cancer at some time in their lives, so the FDA estimates that only one person can get cancer per year, which means that the overall risk is relatively low.
But when the agency realized that valsartan was being sold with an additional name, it became clear that the withdrawal of packages simply labeled as medication would be enough to protect consumers.
FDA Commissioner Scott Gottlieb and the Director of the Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock, have teamed up to launch a comprehensive and collaborative research on all drugs to which the compound can have arrived.
Together, their agencies have assembled a working group comprised of "chemists, toxicologists, physicians, pharmacists, researchers, communication specialists and analytical laboratory personnel" to analyze "this troubling finding," the FDA and CDER said in their statement.
In the process of his ongoing research, he has already been aware of similar levels of NDMA in medicines sold in Europe and is now coordinating with officials there as well.
Similarly, researchers were concerned that people who needed medications to keep their blood pressure from reaching dangerous levels would stop taking their medications out of fear.
Doing so would put them at risk of sudden attacks or myocardial infarctions.
In an attempt to mitigate that problem, the FDA has been continuously updating blood pressure medications that have been and have not been affected by NDMA and are subject to withdrawal.
In their laboratories, the FDA and CDER are still in the process of determining how the NDMA found its way into the pills.
"We believe these risks are introduced through a specific sequence of steps in the manufacturing process, where certain chemical reactions are necessary to form the active ingredient" in Valsartan, they said in their press release.
"Before conducting this analysis, neither the regulators nor the industry fully understood how NDMA could be formed during this process.
"We are still not 100 percent sure that this is the root cause of the problem."
About half of all medicines with valsartan on the market have been withdrawn from the market and others may remain as research continues.
- If you take valsartan and you are not sure if your medicine can be affected by NDMA, you can contact CDER by calling toll-free (855-543-3784) or by sending an email to the FDA at email@example.com