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Heartburn drug risks

| Nov 25, 2020 | Mass Tort Litigation |

Doctors in West Virginia and elsewhere prescribe around 15 million patients the heartburn medication Zantac, and some people buy it without a prescription. Zantac contains a chemical called ranitidine, and it has been tied to cancer risks. Ranitidine has also been found in generic versions of Zantac, based on FDA research.

Stability of ranitidine

Valisure, an online pharmacy, discovered cancer-causing agents called carcinogens in hypertension medication. It found high levels of a carcinogen called NDMA. The FDA sets the daily intake of NDMA at 96 nanograms, but Valisure found more than 2 million nanograms in every pill using an established testing method.

After making adjustments to mimic the conditions of the human abdomen, Valisure discovered that the pills contained 300,000 nanograms. The amount still exceeded the FDA limit by 3,000 times. The pharmacy sent a petition to the FDA, asking for the products with ranitidine to be removed.

Generic brand issues

NDMA may have an adverse effect on the medication in other ways even without ranitidine. In 2018, generic medication made up 90% of medication sold, and 80% of them came from overseas. Sometimes, insurance only covers the lowest-cost version of a brand. However, reduced costs could also mean less quality control.

Experts say there should be no cancer risk when medicine gets manufactured correctly. The FDA conducts overseas inspections but claims it doesn’t have enough resources for independent studies. The FDA usually requires drug manufacturers to get permission to use substitutes, but it takes time to get approvals. This means some foreign manufacturers just add the substance without permission.

Besides the cancer risk, NDMA has the potential to cause liver damage. Mass torts may be able to help patients who suspect Zantac caused their issues get compensation.