A new type of generic valsartan (Diovan) has been approved by the Food and Drug Administration (FDA) to relieve shortages.
Several recalls of drugs were found to contain traces of carcinogenic chemicals, and there is a serious need to make the product review a priority as there is a shortage of the medicine as told by the FDA.
This drug is widely used in the U.S. by patients with high blood pressure, and therefore its shortage can cause a severe problem across the country.
After the availability of new generic versions of valsartan, the FDA said Tuesday that it has approved the generic drug to overcome the short supply ever since chemical contamination case is found.
Subsequently, a Mumbai-based pharmaceutical company known as Alkem Laboratories Limited has developed the new generic version of the high blood pressure medication to cope up the high demand.
The spokesperson from the agency said in an interview, “The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers.”
The recalls began in July last year when the FDA found that certain hypertensive agents contained a potentially cancer-causing chemical called N-nitrosodimethylamine (NDMA), a type of nitrosamine. Moreover, the hazardous substance can occur during the time of manufacturing of the drugs, said by the FDA.
The chemical nitrosamines can lead to malignancy in the liver as well as other organs in lab animals, which can also cause cancer in humans.
According to reports, some of the companies seem to increase the cost of the medicine following its increasing demand, which is why patients have been facing shortages of valsartan and other associated drugs.
As per the further research made by the FDA, it is noticed that the same impurities are present in other blood pressure drugs of the same family of drugs that valsartan belongs to – such as irbesartan and losartan.
The FDA said, “The contaminants ‘are of special concern to global regulators because, unlike most impurities in drugs, they have the potential to cause harm at very low levels.’”
The recalled drugs belong to a class of pharmacological agents called Angiotensin II Receptor Blockers (ARBs) and are mainly used for treating hypertension and heart failure.
The FDA said that not all lots of valsartan, irbesartan, and losartan were contaminated; therefore, not all of them were recalled. As a precaution, the agency recommends consumers to check the labels on their prescription bottles and consult the FDA website for the list of the recalled drugs, and if they are found on the list, they should continue to consume their medicines until they can get replacements.
The FDA warned about the potential risks by stating, “Our scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA, for four years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer beyond the average cancer rate among Americans. Most patients who were exposed to the impurity through the use of affected valsartan received less exposure than in the scenario described above.” Meanwhile, the FDA will be continuing the evaluation of other drugs that belong to that class to make sure they do not contain cancer-causing toxins.
