Several popular medications used to treat high blood pressure may be contaminated with carcinogenic chemicals, the Food and Drug Administration (FDA) warned Thursday.
The agency announced the discovered of a potentially carcinogenic ingredient in valsartan in July, after the manufacturer brought it to their attention in June.
Camber Pharmaceuticdals voluntarily recalled the pills on August 9 after a likely carcinogen known as N-nitrosodimethylamine (NDMA).
The FDA still describes the chemical as only ‘trace’ amounts, but has now discovered that several other manufacturers likely re-packaged and sold generic valsartan under other names.
About 8,000 patients are thought to be at risk from the affected drugs, but the FDA estimates that the incident will not raise the overall cancer rate in the US by more than one case annually.
The common blood pressure drug valsartan and drugs sold under other names but containing valsartan are under FDA investigation after a carcinogen was discovered in the medication
Nearly half of all Americans – over 100 million – have high blood pressure, and the condition leads to the deaths of thousands every year.
Medications to keep pressure under control are life-saving – but for several thousand people in the US (and more, abroad) the drugs meant to keep them alive could have been slowly corrupting their cells into cancer, for years.
The chemical detected in valsartan, NDMA, is considered a ‘probable carcinogen’ to humans.
Pills of the highest dosage of valsartan sold in the US – 320mg – had higher levels of NDMA than the FDA says are acceptable.
Only the 8,000 people that the FDA estimates took this dose on a daily basis for four years are likely to be affected .
About one in every three people will get a cancer at some point in their lives, so the FDA’s estimate that only one more person may get cancer a year means that the overall risk posed by the chemical is relatively low.
But when the agency realized that valsartan was being sold under additional name, became clear that the recall of just packages labelled as the drug would be sufficient to protect consumers.
FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research (CDER) director Dr Janet Woodcock have come together to launch a broad-sweeping, collaborative investigation into any and all drugs the compound may have found its way into.
Together their agencies have pulled together a task force of ‘chemists, toxicologists, medical doctors, pharmacists, investigators, communication specialists, and analytical lab staff’ to look into ‘this troubling finding,’ the FDA and CDER said in their statement.
In the process of its ongoing investigation, it has already learned of similar NDMA levels in drugs sold in Europe and is now coordinating with officials there too.
Equally, the investigators were concerned that people who needed medication to keep their blood pressures from reaching dangerous levels would stop taking their medications out of fear.
Doing so would put them in danger of suffering sudden strokes or heart attacks.
In an attempt to mitigate that issue, the FDA has been continuously updating lists blood pressure medications that have and have not been affected by NDMA and are subject to the recall.
At their labs, the FDA and CDER are still in the process of working out how the NDMA found its way into the pills.
‘We believe that these risks are introduced through a specific sequence of steps in the manufacturing process, where certain chemical reactions are needed to form the active ingredient,’ in valsartan, they said in their press release.
‘Before we undertook this analysis, neither regulators nor industry fully understood how NDMA could form during this process.
‘We are still not 100 percent sure that this is the root cause of the problem.’
About half of the total valsartan drugs on the market have been recalled and more may follow as the investigation continues.
- If you take valsartan and are unsure if your medication might be affected by NDMA, you can contact CDER toll-free at (855-543-3784) or by emailing the FDA at firstname.lastname@example.org