FDA finds probable carcinogen in Zantac and other heartburn drugs
Ken Alltucker, USA TODAY
Published 12:17 p.m. ET Sept. 13, 2019 | Updated 5:52 p.m. ET Sept. 13, 2019

A probable carcinogen that prompted the recall of several versions of blood pressure-lowering pills has been detected in the heartburn drug Zantac and its generic versions, the Food and Drug Administration said Friday.

The FDA and European drug regulators are evaluating possible risk to millions of people who take ranitidine, an antacid and antihistamine used to block stomach acid. Preliminary testing found both brand name and generic versions of the heartburn and acid reflux drug contained a nitrosamine impurity called NDMA, or nitrosodimethylamine, the FDA and the European Medicines Agency reported Friday

The FDA has not called for Sanofi, which makes Zantac, or other generic manufacturers to recall any products from the market. Preliminary tests detected low levels of NDMA that equal or slightly exceed the amounts found in foods such as cured and grilled meats, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The FDA does not recommend people stop taking the drug. However, the agency said people who want to discontinue prescriptions should talk to their doctor or pharmacist. Consumers who buy non-prescription versions can switch to other over-the-counter drugs; there are multiple drugs available for the same or similar uses, the FDA said.

The FDA announcement came after Connecticut-based Valisure, an online pharmacy and laboratory, tested both Zantac and generic versions, and all versions contained NDMA levels significantly higher than the FDA's recommended daily limits. Valisure shared its results with the FDA, which obtained and tested samples of the drug.

"We got different results, much lower, but we found it did indeed contain NDMA," Woodcock said.

Woodcock said the FDA needs to evaluate larger samples of the drug and conduct more tests to ensure the agency produces statistically valid results.

Sanofi representatives issued a statement that said the company takes patient safety seriously and is committed to working with the FDA.

"Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market," Sanofi said in the statement.

Recalls of the blood pressure drugs valsartan, losartan and irbesartan began last July when regulators discovered some drugs had small amounts of NDMA, a carcinogen that FDA scientists concluded would generate one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years. Two other probable carcinogens were also detected in several batches of the blood pressure drugs.

The global recall prompted queries from the U.S. House Committee on Energy and Commerce to the FDA about the blood pressure drugs' regulation and the agency's oversight of the global drug supply chain.

Private-sector labs such as Valisure, which tests every batch of every drug that it sells, have stepped up their testing of prescription drugs. The private lab tested ranitidine, in part, because a co-founder's infant daughter was prescribed the medication, said CEO David Light.

"Our initial results were just so alarming that we immediately took it off our own formulary," Light said.

In addition to sharing testing results with the FDA, Valisure submitted a citizen petition to the FDA requesting the agency initiate a recall and suspend the sale of both branded and generic versions of the drug.

"We think a immediate recall is absolutely in order here, especially considering this drug is given to infants and is over the counter," Light said.

For now, FDA officials say consumers should not be alarmed.

"It's really important to have people not panic over this," Woodcock told USA TODAY. "People who have taken ramitidine or Zantac on and off. This is not really a high risk situation. But contaminants should not be in these drugs. We’re going to make sure they get out."

https://www.usatoday.com/story/news/heal...gen/2310175001/



FDA defends oversight amid questions of safety of generic drugs made in India and China
Ken Alltucker, USA TODAY Published 7:51 p.m. ET May 17, 2019 | Updated 11:46 a.m. ET May 20, 2019
https://www.usatoday.com/story/news/nati...lls/3707843002/