Tell a friend about this global alert

Tell a friend about this global alert

Ranitidine was recently recalled by the FDA over some potential cancer causing impurities.
Ranitidine is widely used to reduce the production of stomach acid in patients with conditions such as heart burns, stomach ulcers and gastroesophageal reflux disease. In some countries this is a prescription only drug, but in Lesotho it is accessed even over-the-counter.

The US Food and Drug Administration (FDA) has learnt of a potential safety issue in Ranitidine containing products. The presence of nitrosamine impurity called N-nitrosodimethylamine (NDMA) has been identified in the products at low levels.

NDMA is classified as a possible human carcinogen (a substance that could cause cancer) based on results from animal studies.
The FDA first warned about the potential impurity in Ranitidine on September 13, 2019. It said: “Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

In its update on October 2, 2019 the FDA said: “FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine . . . To date, the agency’s early limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.”

In the meantime, the FDA has told doctors to discuss other treatment options with patients who are concerned about ranitidine. Patients are advised to consult their health care providers before they stop taking Ranitidine or switch to other medicines that are approved and available in the market for similar indications as Ranitidine. Patients are further encouraged to report side-effects they experience while taking Ranitidine-containing products to their healthcare providers.

It is in situations like this where the existence of an active Drug Regulatory Authority in the country would protect the public through its pharmacovigilance department. It remains heart-breaking that we do not have such a body in Lesotho. All sorts of drugs are roaming the black market, anybody can sell drugs, and the public is at risk!
Let us be safe Basotho, tell a friend to tell a friend regarding this global alert on Ranitidine safety! There are so many brands in the market containing this product.

Retšelisitsoe Nkhahle is a Mosotho pharmacist based in Botswana. She is pursuing an Msc. in Pharmacy.

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