Prilosec (generic: omeprazole/omeprazole magnesium), most commonly used to treat common heartburn and other symptoms associated with Gastroesophageal Reflux Disease, has been linked to increased risks of bone deterioration and fractures of the wrist, hip and spine. In more rare cases, it has also been linked to low serum magnesium levels in the body, which could lead to muscle spasm, irregular heartbeat and seizures.
UPDATE: Heartburn Drugs Linked to Heart Attack Risk
June 11, 2015 — PLOS One has published a study of 2.9 million people that found a 16-21% increased risk of heart attack associated with the use of heartburn medications in the proton pump inhibitor (PPI) class, such as Prilosec and Prevacid. Click here to read more.
July 12, 2013 — Researchers have published a study linking all drugs in the PPI class, including Prilosec, to a potential risk of heart problems. Click here to read more.
January 31, 2012: A study published in the British Medical Journal has found that the use of Proton-Pump Inhibitors (heartburn medications that include Prilosec, Nexium, Prevacid, Aciphex, and more) increases the risk of hip fractures. The researchers found that women who regularly used these medications for at least two years were 35% more likely to suffer a hip fracture. The risk was greatest for post-menopausal women who smoked.
Prilosec: An Overview
FDA approved in 1989, the AstraZeneca manufactured drug called Prilosec belongs to a group of medications called proton pump inhibitors (PPIs). These medications are used to decrease the amount of stomach acid created by the body, in order to reverse the side effects of Gastroesophageal Reflux Disease (GERD or acid reflux disease). Common symptoms of GERD include common heartburn and possible damage to the esophagus (the tube between the throat and stomach). Additionally, Prilosec has been prescribed to treat other illnesses, including certain stomach and small intestine ulcers and Zollinger-Ellison syndrome.
However, several studies suggest Prilosec, Nexium and other PPI medications may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Those most at risk include patients over the age of 50 who received high-doses (defined as more than one dose per day) and used Prilosec long-term (longer than one year).
Recently, the FDA also warned of a more rare condition developed in some Prilosec users. The FDA announced Prilosec and other PPIs may cause low serum magnesium levels (hypomagnesemia) if taken long-term (usually longer than one year). Low magnesium levels can cause serious adverse effects including tetany (muscle spasms), arrhythmias (irregular heartbeat) and seizures.
Due to the severity of these symptoms, Prilosec patients may want to contact a Prilosec lawyer at The Schmidt Firm, PLLC for a free case evaluation to discuss the potential for a Prilosec lawsuit.
Prilosec Side Effects
- Wrist fracture
- Hip fracture
- Spine fracture
- Tetany (muscle spasm)
- Arrhythmia (irregular heartbeat)
Other less serious side effects include:
- Skin rash or itching
- Abdominal or stomach pain
- Increased or decreased appetite
- Joint or muscle pain
- Unusual bleeding or bruising
Prilosec and Bone Fractures
In May 2010, the Food and Drug Administration (FDA) warned doctors and consumers that PPI use could lead to the increased risk of hip, wrist and spine fractures. The statement by the FDA warned that patients who had received high doses of Prilosec and other PPI medications for longer than one year or more were most at risk.
The report cited a 2006 study published in the Journal of the American Medical Association. In the study 135,000 people at least 50 years or older were interviewed. The study found patients who took PPIs for longer than one year at a high dose (defined as more than one dose daily) were 2.65 times more likely to break a hip. The likelihood of fracture was also proven to increase with the length of time the PPI was taken.
Because of this study’s results, as well as the findings from several other similar studies, the FDA is requiring all PPIs to add a new warning label about the potential risk of bone fractures. This warning will not be included on over-the-counter (OTC) versions of these drugs because the FDA determined short-term use (14 days or less) at a low dose was not linked to bone fractures.
Fractures are caused by a low calcium levels in the body, caused by PPIs. When stomach acid is reduced, the body experiences a gradual decrease in health because essential nutrients are not being absorbed. For example, when low stomach acid levels limit the body’s ability to absorb calcium, it may lead to a softening of the bones.
Prilosec and Low Magnesium
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 PPIs 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.
Some patients with this condition required a magnesium supplement to normalize magnesium body levels. However, in a few cases, the supplement was not effective and the patient had to discontinue Prilosec use.
Due to the risk of hypomagnesemia, the FDA has required Prilosec and other PPIs to include additional information in the Warning and Precautions section of the medication label. Over-the-counter versions of the drugs have shown no relationship with lower magnesium levels and are not required to update their labels.
Prilosec and Pregnancy
The FDA has labeled Prilosec as a Category C drug, meaning the medicine has not been studied in pregnant humans, but does appear to cause harm to the fetus in animal studies. In a 1990 animal study of pregnant rabbits, rabbits receiving Prilosec treatment had a slightly increased danger of miscarriage.
Because of the findings in this animal study, it may be possible that Prilosec may cause similar effects in pregnant humans. For this reason, doctors usually do not recommend Prilosec during pregnancy. Also, doctors usually discourage patients from using Prilosec while breastfeeding.
Additionally, although studies suggest that Prilosec is unlikely to significantly increase the risk of birth defects, the FDA has received sporadic reports of birth defects following pregnancy exposure to omeprazole use, including four cases of anecephaly (absence of a large part of the brain or skull) and one case of hydraencephaly (damage to the nervous system).