The U.S. Food and Drug Administration (FDA) is coming down hard after the disclosure that Zantac and other generic ranitidine drugs could contain impurities and carcinogens. Instead of just a little nitrosodimethylamine (NDMA) with a very low risk, the agency says its new “early, limited testing” has found unacceptable levels of NDMA in ranitidine samples.
Note that NDMA is one of three impurities the FDA discovered last year in sartan blood pressure meds that led to a global recall.
The FDA is recommending that drugmakers follow its lead and use a low-heat method of testing the antacids and not the high-temperature method used by a “third-party laboratory,” which it says actually generates NDMA and so displays much greater levels of the impurity. It also has asked drugmakers to send samples to the agency for testing.
Valisure, an online pharmacy firm, notified the FDA and the industry to the presence of NDMA in the heartburn medicines a few weeks back. The firm also filed a Citizen Petition with the FDA seeking to have the agency pull rantitidne drugs from the market and create viable tests for NDMA in them.
Although the FDA now has a test in place, it still has not publicly sought recalls. However, some drugmakers and three of the largest pharmacy retailers in the United States are taking this into their own hands. CVS, Walgreens and Rite Aid have suspended sales of Zantac and other ranitidine products. Walmart has joined this coalition as well.
GlaxoSmithKline, the original developer of Zantac, doesn’t sell ranitidine products in the United States but already has begun the process of pulling them in markets where it does. Sandoz, Dr. Reddy’s Laboratories and Apotex began retrieving their ranitidine drugs from the U.S. market and elsewhere. The Zantac brand is now owned by Sanofi, which has not recalled it in the United States, only Canada where regulators have asked for the drugs to be removed.
24/7 Wall St.Want to Retire Early? Start Here (Sponsor)
Want retirement to come a few years earlier than you’d planned? Or are you ready to retire now, but want an extra set of eyes on your finances?
Now you can speak with up to 3 financial experts in your area for FREE. By simply clicking here you can begin to match with financial professionals who can help you build your plan to retire early. And the best part? The first conversation with them is free.
Click here to match with up to 3 financial pros who would be excited to help you make financial decisions.
Have questions about retirement or personal finance? Email us at [email protected]!
By emailing your questions to 24/7 Wall St., you agree to have them published anonymously on a673b.bigscoots-temp.com.
By submitting your story, you understand and agree that we may use your story, or versions of it, in all media and platforms, including via third parties.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
