FDA commissioner Scott Gottlieb says drug recalls reflect new scrutiny on makers

The head of the Food and Drug Administration says the agency is increasing its focus on drug quality to guard against impurities such as the potentially cancer-causing chemicals that have been found in three commonly prescribed blood pressure medications.

FDA Commissioner Scott Gottlieb spoke to USA TODAY on Wednesday after the recall of versions of valsartanirbesartan and losartan.

Gottlieb said the agency has hired dozens of chemists to review pharmaceutical companies and monitor for any changes in manufacturing techniques. The increased scrutiny is intended to prevent drug impurities that may be harmful to consumers.

“We put out very big guidance on this – it’s a known risk,” Gottlieb said during a meeting with the USA TODAY editorial board on Wednesday. “It’s a place where there’s been a significant increase in focus in recent years.”

The FDA is still investigating the scope of the manufacturing problem that led to the recalls.

Sandoz Inc. recalled losartan potassium hydrochlorothiazide tablets this month because the pills could contain the probable carcinogen N-nitrosodiethylamine, or NDEA. That followed the recalls of valsartan and irbesartan.

Patients who are currently taking versions of the recalled drugs are urged to talk with their pharmacist or doctor. Discontinuing use of a blood pressure drug could cause greater harm to a patient than the small increased risk of cancer.

The losartan potassium hydrochlorothiazide medication affected by the recall are 100 milligram/25 milligram tablets with the lot number JB8912. The contaminated medication was shipped after Oct. 8. It was made by Zhejiang Huahai Pharmaceutical Co. in Linhai, China.

A Sandoz representative said the drug company detected the impurity in its losartan drug ingredient during routine testing. Sandoz is the generic division of Swiss drug maker Novartis.

“We are exploring all possible options jointly with health authorities to facilitate a continuous supply of losartan to cover patient needs,” spokeswoman Sofina Mirza-Reid said. 

The wide-ranging investigation of the class of blood pressure medications called angiotensin II receptor blockers began June 19, officials said. That’s when Prinston Pharmaceuticals notified the FDA about impurities found in its blood-pressure medication, valsartan, made by Zhejiang Huahai Pharmaceuticals, a manufacturer in Linhai, China.

The initial recall involved three drug companies that sold five versions of valsartan supplied by Zhejiang.

Several batches of the recalled valsartan and valsartan/hydrochlorothiazide were contaminated with the carcinogen N-nitrosodimethylamine, or NDMA. 

Zhejiang stopped sending the contaminated valsartan to the United States, the FDA said.

FDA officials said the agency is still investigating whether Zhejiang or other manufacturers made contaminated versions of angiotensin II receptor blockers.

The FDA suspects that the impurities stemmed from changes in Zhejiang’s manufacturing process.

But the agency has not yet verified the root cause of how the contaminants formed, and why they were not separated from the drug during the manufacturing process.

The FDA has tested samples of valsartan and other drugs at its laboratory in St. Louis, officials said. 

 

 

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