Online pharmacy Valisure has actually discovered another cancer-causing chemical in blood-pressure medications made by companies including Novartis. This is documented in a petition to the U.S. Food and Drug Administration.
The filing to the FDA includes a solvent called dimethylformamide, or DMF, found in the heart drug valsartan, according to Valisure. The New Haven, Connecticut-based pharmacy operation asked for that the FDA lower the amount of DMF that is allowed in medications and to remember the valsartan determined to hold high levels of DMF.
Multiple versions of generic valsartan have been recalled in recent years, when the chemical N-Nitrosodimethylamine, or NDMA, was discovered in a Chinese-made variation of valsartan. For years it has actually been used to treat high blood pressure.
The FDA in March stated the pollutants found in the recalled medications might have been the result of chemical reactions that take place in the drug-making process, or from the reuse of materials, such as solvents.
This puts the person who takes these medications at risk of eventually developing cancer. Ingesting a known carcinogen on a regular basis for any length of time can greatly increase the risk of developing cancer. Some patients end up taking the drug indefinitely or stay on it for years.
The FDA will review Valisure's findings, but there is still a cause for concern. However, patients should continue to take their blood-pressure medication no matter whether it's been recalled or not until they can talk to their physician. Their physician may offer an alternative or will be able to guide them on what is best for them.
The issue with fully discontinuing Valsartan
The drugmaker cannot fully discontinue the making of Valsartan, due to the number of patients who currently still need it. The demand of patients and the FDA's reluctance to leave patients without medication means that the drug will still be manufactured until alternatives are provided. This also gives patients ample time to be notified of the situation and to visit their physician to find an alternative.
The World Health Organization categorized DMF as a possible carcinogen last year.
The FDA does not routinely test pharmaceuticals, counting on makers to make sure their products are safe and effective. The FDA takes these findings and either approves or denies them for use with widespread patients. They have to determine whether these drugs are safe. When a substance, such as a known carcinogen is found, they have no choice but to issue a recall.
Novartis, the company that makes Diovan, a brand-name variation of valsartan, said it generally does not utilize DMF in making its medications. Its suppliers suggested that they do not, either.
That stated, “Novartis can not presently fully exclude the possibility that traces of DMF (within appropriate limits) might have been present in materials of other drug substances suppliers,” a representative for the drugmaker said.
Unfortunately, even though a drug has been approved for usage in the mainstream population, it doesn't mean that other manufacturers will make it the same way as the original company. This is how drugs with impurities slip through the system and find their way into the hands of patients across the United States.
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