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To Combat Blood Pressure Drug Shortage, FDA Has Permitted Valsartan Generic

The Food and Drug Administration (FDA) uploaded important information on its website publishing a list of blood pressure medications recalled for comprising carcinogenic compounds.

At the beginning of the week, the FDA gave approval to the new generic version of valsartan for counter balancing the recent scarcity of the blood pressure medicines in the market, after successive safety recalls.

The versions of the three usually prescribed generic blood pressure medications losartan, valsartan, and irbesartan, have been recalled by FDA for more than 15 times due to the presence of trace amounts of carcinogenic compounds in the medicines.

Scott Gottlieb, FDA Commissioner, stated that after the recall of nitrosamine adulterated medicine valsartan, which resulted in a significant shortage of this class of medicines in the market. Gottlieb said that the agency organized an evaluation of applications for new generic versions to focus on the shortage of drugs. However, the recall for the generic drug version, Diovan, is still pending.

After the evaluation at the manufacturing facility and testing valsartan drug, the FDA said that there are no impurities present in the medicine, which have been found in another generic version of blood pressure medicines.

The India-based manufacturing facility, Alkem Laboratories Ltd., Mumbai, has not responded immediately over the matter.

Huge lots of medications valsartan, losartan, and irbesartan were called by the drug manufacturers after it was identified that the drugs had traces of N-Nitrosodimethylamine, known as NDMA. A series of investigations showed that even a few lots of valsartan also comprised another possible carcinogenic compound, N-Nitrosodiethylamine (NDEA).

During the recent recalls, a third potential carcinogen—NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) was identified in some of the medicines in the same drug class.

At the end of the last month, 87 lots of losartan were recalled by Camber Pharmaceuticals Inc., as the trace amounts of NMBA was found in those drugs too.

However, doctors recommend patients to be on medication until a replacement for that drug would be available in the market. As total discontinuation of a recalled drug could be more harmful than consuming the drug.

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