FDA reports more ranitidine recalls

The FDA has added at least three additional items to its growing roster of heartburn drug recalls.

The onslaught of new recalls were announced between Jan. 6 and Jan. 8, three months after the FDA first warned consumers of potential carcinogens in over-the-counter heartburn medications. By Sept. 18, Zantac drugmaker Novartis had halted all distribution of generic Zantac—ranitidine—and by Sept. 30 CVS had pulled all Zantac and generic-brand ranitidine from its shelves.

Denton Pharma, Inc., doing business as Northwind Pharmaceuticals, issued a voluntary recall of all unexpired lots of ranitidine tablets, both 150 mg and 300 mg, to the consumer level Jan. 6. According to its statement the company hasn’t received any reports of adverse events directly linked to the recall, but lab results identified trace amounts of N-nitrosodimethylamine (NDMA) in seven lots of Northwind’s product.

A day later Appco Pharma LLC announced it would be recalling all lots, within expiry, of its ranitidine hydrochloride capsules. Like Northwind, Appco cited NDMA levels higher than the FDA’s acceptable daily intake levels as the culprit behind its decision, which affected both 150 mg and 300 mg tablets. High-dose ranitidine hydrochloride is a prescription-only drug indicated for the treatment of ulcers, reflux esophagitis and Zollinger-Ellison Syndrome; ranitidine manufactured by Northwind was also prescription-only and indicated for ulcer treatment and prevention and acid reflux.

Mylan Pharmaceuticals joined the FDA’s roster on Jan. 8, announcing a voluntary nationwide recall of three lots of nizatidine, an antacid used to treat ulcers, esophagitis and acid reflux, due to trace amounts of NDMA.

Experts have acknowledged that the amounts of NDMA found in these medications have been low—a CVS statement from September read the levels the FDA was finding in recalled ranitidine “barely exceed amounts found in common foods”—but it shouldn’t be neglected. Raghu Tadikamalla, a cardiologist with the Allegheny Health Network, told WPXI Pittsburgh last November that we can likely expect further recalls in the future.

“This may be the tip of the iceberg, because we only found out about this a year ago and the FDA is starting to test other medications,” he said of the Zantac recalls. “I think from time to time we’re going to find more lots of different medications being recalled. We’re going to have to deal with it as time goes on.”

Northwind and Appco suggest patients who bought ranitidine subject to the recent recall immediately discontinue use and discard their remaining product. The companies suggest people speak with their physicians about other, safer, treatment options.