FDA declares 40 generics free of carcinogens as 'sartan' recalls continue

As recalls on blood pressure drugs continue to plague drugmakers, the FDA declared a slate of 40 generic pills safe to use.

On Thursday, the agency released a list of 40 generic angiotensin II receptor blockers (ARBs) that are free of three potentially carcinogenic compounds linked to various "sartan" drugs, including valsartan and losartan.

The FDA launched a global recall in 2018 after a U.S. drug manufacturer found high levels of N-nitrosodimethylamine (NDMA) in the valsartan active ingredient it had bought from a Chinese supplier. Since then, the FDA discovered that NDMA, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA—all considered unsafe at certain levels—can be created during sartan drug manufacturing under certain conditions. 

The first global recall included all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco.

The recall later expanded to other "sartan" products as impurities turned up in the irbesartan API produced by India’s Aurobindo and in losartan products made using an API from China’s Zhejiang Huahai Pharmaceuticals.

With an investigation underway, the FDA's top two drug officials reiterated in a joint statement that generics with carcinogen levels higher than the accepted limit would be temporarily distributed to prevent a shortage of losartan, which is used to treat high blood pressure and prevent heart failure.

Outgoing FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research, said agency scientists believe using the tainted drugs temporarily wouldn't raise cancer risks in a "meaningful" way. "After careful evaluation of safety data and consideration of the benefits and risks to patients, we think it’s critical that patients have access to these drugs while impurity-free losartan is manufactured," the Thursday statement said.

Gottlieb and Woodcock said they expected carcinogen-free products to replenish the U.S. supply of losartan within six months.

"We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medicines far outweighs the low risk associated with continuing the medications with these impurities," they said.

After the recalls, a suite of lawsuits were filed against drugmakers cited by the FDA, including Indian drugmaker Aurobindo and Huahai.

In October, Huahai told the Shanghai Stock Exchange that it faced lawsuits in four states over its production of tainted valsartan.

In a federal suit in Florida, consumers accused Walmart, Aurobindo, U.S. drugmaker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals of producing and selling tainted irbesartan that may have exacerbated health conditions.

In an attempt to begin cleaning up the valsartan market, the FDA hustled through a new valsartan generic from India’s Alkem Laboratories last month. The agency said Alkem's Diovan copy was free from NDMA and NDEA.

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.