USA- Health.harvard.edu writes that the recall of the commonly used heartburn medication, Zantac, has been expanded. The recall of Zantac, which is the brand name for ranitidine, was originally reported to the FDA by Valisure, an online pharmacy. Valisure had found that the medication had what they referred to as “extremely high levels” of NDMA, a […]
Zantac NDMA Contamination
USA- Health.harvard.edu writes that the recall of the commonly used heartburn medication, Zantac, has been expanded. The recall of Zantac, which is the brand name for ranitidine, was originally reported to the FDA by Valisure, an online pharmacy. Valisure had found that the medication had what they referred to as “extremely high levels” of NDMA, a substance that is widely regarded as cancer-causing.
The FDA conducted additional tests and found NDMA in low levels in the medication. According to an explanation from the FDA, the testing that indicated the higher levels of the chemical was done at higher temperatures than other tests. The human body would never produce the high levels of heat the drug was exposed to, meaning that the conditions under which such high levels were found were not similar to the conditions of storage of the medication or of what would happen to the medication when taken by a person.
As a precautionary measure, the FDA is asking companies that make ranitidine and other similar medications test the drugs at heat levels similar to the human body.
The FDA has not taken Zantac and other forms of ranitidine off the market in response to the findings. Some manufacturers issued recalls on their own, and certain pharmacies have recalled the medication as well.
NDMA was found in another type of drug, angiotensin receptor blockers, which are prescribed to patients with high blood pressure. It is unclear whether the NDMA found in ranitidine is similar to the amount found in the angiotensin receptor blockers. Patients taking Zantac are urged to speak with their doctors about whether they need the medication and about whether the risks outweigh the benefits.
