Eric Palmer, FiercePharma
Novartis has gotten out in front of an FDA, and its competitors, by halting worldwide distribution of its generic Zantac. It took the step as regulators globally have instituted different approaches after discovering that a suspected cancer-causing impurity has been detected in the popular over-the-counter antacid.
The FDA decided it was unnecessary to have drugmakers recall their generic Zantac antacids while it investigates, while Canada and some European regulators have taken a more aggressive approach, asking drugmakers to stop distribution. Unlike a recall, it means that stocks of the drugs already in stores can be sold.
Novartis on Wednesday said it was stopping worldwide distribution of its generic versions of the antacid while regulators investigate the fact that the impurity N-nitrosodimethylamine (NDMA) has been detected these ranitidine-based drugs.
“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the U.S.,” Eric Althoff, head of global media relations, said today in an email. “Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant health authorities as required.”
Sanofi, which sells branded Zantac over the counter, is taking a less proactive approach. A spokesperson said today that there currently “are no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada.”
She said the French drugmaker is working closely with the FDA on the situation and pointed out the agency has said preliminary tests show the levels of NDMA in Zantac barely exceed amounts found in common foods.
The FDA last week alerted the public to the fact that NDMA has been found in ranitidine meds and is investigating to determine the source of the tainted ingredient and its risks at the levels in those drugs. So far, the FDA claims, the risk to consumers seems small.
The FDA was tipped off recently to the fact that NDMA was showing up in ranitidine drugs by Valisure, an online pharmacy that prides itself on thoroughly testing all batches of the drugs it buys before selling them. Valisure has filed a Citizen Petition urging the FDA to recall all of the ranitidine drugs and set standards like it has with the blood pressure meds.
NDMA is the same impurity that last year set off a global recall of blood pressure medicines including valsartan and losartan. The FDA determined that the NDMA and two other probable cancer-causing agents can be created during certain manufacturing steps involving the use of solvents. The FDA has now set acceptable limits for NDMA.
Sandoz says it is working to stay on top of the evolving situation evolving the impurities and halted distribution of affected antacids as soon as it learned elevated levels of NDMA had been detected.
“Scientific insights on the potential formation of NDMA are evolving constantly and we are adapting our assessments and tests accordingly on an ongoing basis,” Novartis said today. “We have and will continue to work hard to ensure the highest quality of all our products. We are committed to ensuring transparency and integrity.”