When a muscle in the esophagus fails to close properly, it could cause stomach acid to come back up into the esophagus. If the condition lasts for a long period of time, it is known as gastroesophageal reflux disease (GERD).
GERD affects roughly one in four people in the United States1, resulting in discomfort and even damage to the esophagus. Fortunately, for sufferers of GERD and other esophageal problems, pharmaceutical companies have come up with a solution in medications known as proton pump inhibitors (PPIs).
One of the first and most influential PPIs was Prilosec, which became the top-selling drug in the world for a time. Countless people have taken Prilosec to treat symptoms of GERD and other stomach conditions.
What many users of the drug didn’t know is that Prilosec may carry increased risks of severe complications, including kidney damage, stroke, dementia, and more.
Omeprazole, which is sold under the brand name Prilosec, was first approved for treatment of GERD by the U.S. Food and Drug Administration (FDA) in 1989 when it was marketed by Astra AB — now known as AstraZeneca. It was initially sold under the name Losec but was changed to Prilosec in 1990 to avoid confusion with another drug.
Prilosec was the first in a class of drugs known as proton pump inhibitors (PPIs). These types of drugs work by blocking pumps in the stomach that make acid. This ultimately prevents a buildup of stomach acid that causes heartburn.
Within a decade, Prilosec became one of the top-selling drugs in the world. In 2003, Prilosec OTC became the first PPI available for sale over the counter. By the following year, the over-the-counter version became the top-selling medicine used to treat frequent heartburn.
At the time, Prilosec OTC was hailed as a safe and effective self-treatment option for people with heartburn2.
“As has been the case for many other over-the-counter switches, the availability of Prilosec OTC will help reduce costs and expand the availability of treatment options for millions of Americans,” said Mark B. McClellan, Commissioner of Food and Drugs.
The patent for Prilosec expired in 2001, but AstraZeneca was able to extend the patent period and keep generics from hitting the market while it attempted to move prescribers over to its newer heartburn drug called Nexium.
Since then, millions of people have taken prescription and over-the-counter versions of Prilosec. However, sales have declined over the years.
Uses for Prilosec
Since it was first introduced, Prilosec has been approved for several uses.
- GERD: The FDA has approved Prilosec for the treatment of GERD, sometimes known as acid reflux disease. Adults and children 1 year or older are able to take Prilosec for GERD.
- Erosive Esophagitis: When heartburn happens frequently, the acid can do damage to the esophagus. Prilosec is approved in the treatment and healing of erosive esophagitis.
- Ulcers: Prilosec is also indicated for the short-term treatment of gastric ulcers and duodenal ulcers in adults.
- Pathological Hypersecretory: Prilosec has been approved to treat conditions like Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis.
Common Side Effects
According to RxList3, common side effects of Prilosec include:
- Stomach pain
- Stuffy nose
- Sore throat
Dangers of Long-Term Use of Prilosec
PPIs like Prilosec are not designed for long-term use. Most of the indications for Prilosec are for four to eight weeks. When Prilosec is taken for longer, it could pose serious risks to users. Here are just a few of the dangers of long-term use.
The link between kidney injuries and Prilosec date back to 1992 when a study The American Journal of Medicine concluded that there was an association between omeprazole and acute interstitial nephritis, a condition that can cause kidney failure4.
More recent studies have also linked PPIs to chronic kidney disease. In 2016, a study published in JAMA Internal Medicine looked at thousands of patients5. Researchers concluded that PPIs are associated with a higher risk of chronic kidney disease.
“We note that our study is observational and does not provide evidence of causality,” the study says. “However, a causal relationship between PPI use and CKD could have a considerable public health effect given the widespread extent of use.”
Other studies have found that people may not even be aware of the kidney damage occurring while taking the drugs. A 2017 study found that more than half of the people who developed kidney damage did not have any problems beforehand.
“Our results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure,” the study’s senior author Ziyad Al-Aly said in a news release6. “Patients should be cautioned to tell their doctors if they’re taking PPIs and only use the drugs when necessary.”
Bone fractures have also been linked to long-term use of the drug. The FDA even issued an update to the labels of all PPIs in 2010 warning of a fracture risk in those who take PPIs for a year or longer7.
“The new safety information is based on FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use,” the FDA reported at the time.
The labels for Prilosec now reflect the increased risks.
Along with decreased calcium absorption that could cause bone fractures, using Prilosec for too long could also decrease magnesium absorption. As a result, a patient may experience hypomagnesemia. Symptoms include seizures, low blood pressure, and arrhythmias.
In 2011, the FDA issued a warning for all PPIs that long-term use could result in low levels of magnesium8.
Patients who take Prilosec are also susceptible to infections. In cases of the bacterium C difficile, one study9 found that “patients had a 2.9-fold increase in the risk of acquiring C difficile than patients who were not on a PPI.” Users were also more likely to suffer from recurring infections after ending treatment.
AstraZeneca has been at the center of several lawsuits over the years related to its heartburn drugs, including Prilosec and Nexium. Some of the first lawsuits against Nexium and Prilosec dealt with allegations that the PPIs led to bone fractures.
However, more recent lawsuits have focused entirely on allegations that Prilosec and other heartburn medications have caused kidney damage. Plaintiffs in lawsuits claim that AstraZeneca was aware of the kidney-related risks as early as 2004. But, in order to maintain profits, plaintiffs say the company withheld information from the public.
More than 4,000 lawsuits against the makers of PPIs, such as AstraZeneca, have been consolidated in the U.S. District Court of New Jersey after the U.S. Judicial Panel on Multidistrict Litigation agreed that all the cases dealt with similar questions of fact. The lawsuits are currently progressing through the system but lawyers expect more cases to be filed in the coming months.
Those who have suffered from kidney damage or any other unexpected side effects should contact an attorney to learn more about how a lawsuit could help them get the justice they deserve.