FDA releases additional NDMA testing method and alerts health care professionals and patients to multiple voluntary recalls of ranitidine
The U.S. Food and Drug Administration is releasing a second liquid chromatography-mass spectrometry (LC- MS) method for manufacturers and regulators to detect and quantify NDMA in ranitidine. The agency is using this method to test potential NDMA-containing ranitidine samples. The second LC-MS method for NDMA in ranitidine uses a more widely available technology than the first posted method. The agency is sharing the second method to provide alternatives to firms wishing to test their drug products for NDMA.
FDA is also alerting health care professionals and patients to two voluntary recalls of ranitidine:
- Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
- Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.
Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s preliminary tests of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these tested medicines at this time.
FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available. See Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) for more information.
.png)
No hay comentarios:
Publicar un comentario