At least one drug maker has incurred a significant financial hit because of recent recalls involving Zantac and other ranitidine-containing heartburn medications, a possible sign of what might await others in the pharmaceutical industry.
According to FiercePharma.com, Dr. Reddy’s Laboratories, which has recalled 33 ranitidine products since September 13th, reported this week that U.S. sales had fallen $25 million compared to the previous quarter.
“Our North America generics recorded sales of $202 million for the quarter and declined by 1% year over year and 14% on a sequential quarter basis,” CEO Erez Israeli said during earnings call this month. “The sequential decline was primarily driven by certain issues impacting the quarter such as a, provisions related to nationwide recall of ranitidine product due to NDMA impurities limits following FDA’s caution note regarding the same.”
Drug makers began recalling name-brand and generic Zantac products in September, shortly after the U.S. Food & Drug Administration (FDA) warned that testing had detected N-nitrosodimethylamine (NDMA), a probable human carcinogen, in some drug samples.
The agency was informed of the contamination by Valisure, an online pharmacy that found NDMA in every batch of ranitidine and Zantac it tested, and frequently at levels far higher than the FDA’s daily limits.
Valisure maintains the presence of NDMA was the result of the ranitidine molecule’s instability, which purportedly degrades when subjected to conditions similar to human digestion. While the FDA indicated its early testing suggested this is not the case, the agency plans to conduct human tests to better understand whether NDMA forms in the stomach upon ingestion of ranitidine.
In addition to Dr. Reddy’s Laboratories, other drug makers – including Sandoz, Sanofi-Aventis, and GlaxoSmithKline have opted to voluntarily recall their Zantac and ranitidine products. Three additional recalls were announced in just the past week by Amneal Pharmaceuticals, Aurobindo Pharma USA, and American Health Packaging.
Several retailers, including CVS, Walmart, Walgreens, and Rite-Aid, have pulled the drugs – recalled or otherwise – from their store shelves, while regulators in more than 40 other countries have halted ranitidine sales or taken other steps to protect consumers.
Although the FDA has not ordered any Zantac recalls, the agency has advised consumers taking over-the-counter ranitidine products to consider switching to an alternative heartburn medication. Those taking prescription versions should not stop taking their medication without talking to their doctor, as doing so could worsen the condition being treated.
The NDMA contamination has also led several plaintiffs to file Zantac lawsuits in courts around the United States. Some of these complaints blame tainted drugs for causing cancer, while others seek economic damages and medical monitoring for consumers who purchased the medications.