U.K. health regulators have issued two new warnings to the public stating that the use of proton pump inhibitor (PPI) heartburn drugs may cause bone fractures, and have the potential to lead to dangerously low levels of magnesium in the body. According to the warnings, these risks are increased if high doses of PPIs are taken over long periods of time, and appear to primarily affect the elderly. Heartburn drugs belonging to the PPI class include Nexium, Prilosec, Protonix, Prevacid, Aciphex, Dexilant, Vimovo and Zegerid.
What’s the problem?
April 25, 2012 – During the month of April, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued two separate warnings regarding proton pump inhibitor heartburn medications. The first warning stated that new evidence indicates an increased risk of hip, spine and wrist fractures associated with PPI use. The MHRA advised patients taking the medications to be sure they are getting enough calcium and vitamin D in their diets to reduce the bone fracture risk.
The other warning involved severe cases of magnesium deficiency (also known as hypomagnesaemia) which have been increasingly linked to PPIs. According to the statement, magnesium deficiency is associated with long-term use of the drugs at high doses. This evidence came from a review of adverse event reports sent to health authorities across Europe. In severe cases, hypomagnesaemia can cause fatigue, delirium, convulsion, dizziness, and other serious side effects.
Proton pump inhibitors are designed to reduce the amount of acid in the stomach, and are generally prescribed to treat the following conditions:
- gastroesophageal reflux disease (GERD)
- ulcers in the stomach and small intestines
- inflammation of the esophagus
In May 2010, the U.S. Food & Drug Administration (FDA) issued a warning stating that there may be an increased risk of bone fractures from PPI heartburn medications. The warning was updated a year later with an indication that this risk was linked to high doses of the drugs taken over prolonged periods of time. According to the FDA, this risk does not apply to over-the-counter PPIs.
The consumer watchdog group Public Citizen has petitioned the FDA to require black box warnings to be added to PPI labels, alerting users that the drugs have been linked to bone fractures and can cause dependency in a relatively short period of time.
Over the past several years, a growing number of PPI bone fracture lawsuits have been filed in courthouses around the country. The claims allege that drugmakers failed to adequately research their drugs and neglected to warn the public about the risk of bone fractures.