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The Food and Drug Administration announced Tuesday that it has approved a new generic version of the drug commonly used against hypotension Diovan, or valsartan, which was the subject of a shortage following recalls made due from a chemical contamination.
The new version is produced by Alkem Laboratories Limited, based in Mumbai, India.
"The F.D.A. has given priority to the review of this drug application to help address the recent shortage of this critical drug following multiple recalls of generic products to valsartan from multiple manufacturers, "said the agency in a statement.
Recalls began in July when the F.D.A. found that certain valsartan products contained a potentially carcinogenic chemical, a type of nitrosamine called N-nitrosodimethylamine, or NDMA. European regulators had already made the same discovery. The substance may be formed during manufacturing if the chemical reactions used to make the drug are not carefully controlled and monitored, says F.D.A. I said.
Nitrosamines can cause tumors to the liver and other organs in laboratory animals and are also carcinogenic to humans.
After several reminders of valsartan and related drugs, patients faced a shortage of popular drugs and, in some cases, much higher prices, as companies seemed to benefit from the situation, according to reports.
The contaminated valsartan came from a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company. Three companies have distributed in the United States: Major Pharmaceuticals; Teva Pharmaceutical Industries; and Solco Healthcare, which is owned by Huahai Pharmaceutical.
Further investigation revealed the presence of the same type of impurities in two other antihypertensive drugs of the same class as valsartan: irbesartan and losartan. Two other nitrosamines, nitrosodiethylamine or NDEA and N-nitroso-N-methyl-4-aminobutyric acid, or NMBA, have been discovered. The relevant product lists are posted on the F.D.A. website. Other manufacturers have been involved.
The F.D.A. said that "contaminants are a particular concern for global regulators because, unlike most of the impurities in drugs, they have the potential to cause damage at very low concentrations".
Contaminated drugs belong to a class called angiotensin II receptor blockers, or ARBs. They can treat heart failure as well as high blood pressure.
The F.D.A. stated that all lots of valsartan, irbesartan and losartan were not affected and that they were not all recalled. The agency said that consumers should check the labels on their drug vials and consult the F.D.A. The website containing the list of recalled products, and even if theirs is on the list, should continue to take their medications until they can get replacements.
A statement on the F.D.A. The website explains the degree of risk: "Our scientists estimate that if 8,000 people took the highest daily dose of valsartan (320 mg) containing NDMA, for four years (the time, in our opinion, estimated that the affected products had been in the US market), there may be an additional case of cancer beyond the average cancer rate among Americans. Most patients who were exposed to the impurity with valsartan affected were less exposed than in the scenario described above. "
The F.D.A. stated that he continued to evaluate other drugs of this class "to make sure that they did not contain any impurities".
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