FDA Issues Warning About PPIs

The US Food and Drug Administration has issued a statement warning physicians and patients of an elevated risk in fractures of  the the hip, spine and wrist after taking a popular class of drug prescribed to reduce acid reflux and symptoms of GERD (Reuters).  These medications are also used to treat peptic ulcers, and even H. pylori.

The class of drugs, which are called proton pump inhibitors, have been known to increase fracture risk in higher doses for over a year.  While the agency has not issued a recall, they have stated that packaging of the drug will include a warning about fractures from now on.

The drugs included in the proton pump inhibitor class are: AstraZeneca’s Nexium and Prilosec; Johnson & Johnson’s Aciphex and Novartis AG’s Prevacid.  Some of these medications are prescribed while others are over-the-counter.

The FDA is urging doctors and patients to weigh the benefits against increased fracture risk on a case by case basis.  Another alternative is to reduce the amount of time the patient undergoes therapy with a proton pump inhibitor.  Typically, they are taken once a day, or in some severe cases, they may be taken twice.

Proton Pump Inhbitors raise fracture risk by reducing the amount of calcium within the bones (WebMD). 

Despite the risk, PPIs are extremely effective; they reduce stomach acid by up to 90%.  After 4 weeks of treatment, ulcers are usually healed, especially if a PPI is prescribed with an antibiotic.   Other antacids take longer to heal ulcers.

Other side effects of the drug are headache and diarrhea.  They can also interfere with the drugs Coumadin and Dilantin, and may increase the chance of developing certain infections.

The FDA is urging consumers to contact the agency if they experience problems with a PPI.  The agency can be reached through its MedWatchAdverse Event Reporting program at (www.fda.gov/MedWatch), or by calling 800-332-1088 (Reuters).