Since first approved by the U.S. Food and Drug Administration (FDA) in 1989 to treat heartburn, Prilosec has been linked to numerous side effects. Some of these side effects have triggered lawsuits against the manufacturer.
Prilosec is a proton pump inhibitor. Proton pump inhibitors are a type of medication that decreases the amount of stomach acid to prevent Gastroesophageal Reflux Disease (GERD) or acid reflux. They act by blocking the production of acid.
The primary symptoms of GERD are heartburn, an acid taste in the mouth, and regurgitation. Prilosec is also prescribed to treat certain stomach/intestinal ulcers and Zollinger-Ellison syndrome.
Common side effects of Prilosec include:
- fever or cold symptoms
- sore throat
Some newly discovered side effects may include:
- Kidney failure
- Chronic kidney disease
- bone fractures
- low magnesium levels
- Tetany (muscle spasm)
- Arrhythmia (irregular heartbeat)
In 2016, JAMA International Medicine published a study linking proton pump inhibitors with a 20-50% increased risk of Chronic Kidney Disease. The conclusions were based on more than 13 years of data on 10,500 patients who used proton pump inhibitors or non-proton pump inhibitors heartburn drugs.
In May 2010, the FDA warned doctors and consumers that proton pump inhibitors could lead to the increased risk of hip, wrist and spine fractures. The FDA warned that patients who had received high doses of Prilosec and other proton pump inhibitor medications for longer than one year or more were most at risk.
In March 2011, The FDA issued a safety alert that Prilosec usage may lead to a rare condition called hypomagnesemia, which is characterized by low serum magnesium levels in the body. Patients who developed hypomagnesium had taken Prilosec or other proton pump inhibitors for an extended period, usually longer than one year, although there were cases in patients who had only taken the drug for three months. Low magnesium levels are dangerous because they may lead to seizures, muscle spasm or an irregular heartbeat.
Prilosec is not the only proton pump inhibitor currently facing lawsuits. The makers of Nexium, AstraZeneca, are also facing lawsuits.