A drug recall removes an over-the-counter or prescription drug from the market. In this country, it is the job of the FDA to recall said drugs when certain criteria are met, although the drug company may recall the drug first.
Zantac, which has been a popular heartburn medication, was pulled from the shelves about 6 months ago by many retailers. As of April 1, 2020, the FDA is calling for a recall. Given the controversy swirling around this particular drug, many are wondering if a product liability lawsuit is appropriate.
What is Zantac?
Zantac (ranitidine) is a histamine-2 blocker, and reduces the production of acid in the stomach.
Zantac is prescribed to treat and prevent stomach and intestinal ulcers. It also treats Zollinger-Ellison syndrome and gastroesophageal reflux disease (GERD), a condition in which acid backs up from the stomach into the esophagus, causing heartburn.
Zantac is prescribed over 15 million times annually, and has been available for decades. In September, however, the FDA reported that testing showed versions of Zantac and its generic, ranitidine, contained a probable carcinogen. This caused the French manufacturer Sanofi, as well as generic drug makers, to voluntarily recall Zantac from retailers and drugstores.
The Zantac Problem
The FDA discovered unacceptable levels of the probable carcinogen nitrosodimethylamine (NDMA) in Zantac and generic medications. The agency has asked drug manufacturers to test and recall the drugs if NDMA levels exceed its standards. The voluntary recall also included a similar drug, nizatidine, sold under the brand name Axid.
The FDA is advising consumers taking over-the-counter Zantac (ranitidine) to stop taking the medication immediately. They recommend utilizing other approved OTC alternatives. Patients taking prescription ranitidine should consult their physician regarding other possible treatment options before stopping the medicine.
Which drugs are alternatives? The FDA’s testing protocol has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Recall Classifications
Drug recalls have three different classifications.
- Class I: The most serious classification indicates that consumption of (or exposure to) the named drug will lead to severe health effects or even death.
- Class II: This classification refers to drugs that cause adverse effects, but they are temporary or medically reversible.
- Class III: The most mild classification indicates some problem with the drug, but adverse health effects are not likely due to its use.
I’m a Zantac User – Can I Sue?
The FDA has found that some Zantac products have NDMA in amounts 26,000 times greater than what is considered “safe.” Some Zantac users have been diagnosed with such serious conditions as stomach cancer, bladder cancer, kidney failure and liver damage. Other lesser reactions include nausea, vomiting, and dizziness, severe abdominal pain and headaches, and irregularities in the blood which may cause immune system weakness.
Those patients which took Zantac for over 6 months and are experiencing any of the above conditions may be wondering if it is possible to sue for medical bills, pain and suffering, and future medical issues. If you have experienced problems with Zantac or any other drug, you may have a lawsuit if it caused adverse issues. Be sure to have your medical history documented.
These types of lawsuits fall under product liability laws. If you are interested in investigating your legal rights after taking Zantac or any other recalled drug, call a local product liability attorney to discuss th e merits of your case.
Probinsky & Cole are experts in personal injury, product liability and immigration cases in the Sarasota and Tampa area. We are happy to help answer any questions you may have.
