On Tuesday, the United States Food and Drug Administration (“FDA”) suggested a connection between the long-term use of widely available heartburn medications and increased risk of bone fractures, particularly in the hip, wrist, and spine. The heartburn drugs under examination are called proton pump inhibitors (“PPI”) and include best-selling medications like Nexium, Prevacid, Aciphex, Protonix, Vimovo, Zegerid, and Prilosec. Even lower dosage, over-the-counter strength medications in this class of drugs that are used to control the amount of acid in the stomach can result in an increased risk of fractures. The FDA has issued the warning after reviewing six studies conducted by American and Canadian researchers that linked the use of PPIs with fracture risk in middle-aged adults. These studies found a possible increased risk of bone fractures with the use of proton pump inhibitors used for one year or longer or at high doses.
Proton Pump Inhibitors are the most powerful class of antacid drugs and the third highest-selling class of drugs in the United States. Doctors write 113.4 million prescriptions for these drugs annually, though three of the drugs, Prevacid, Prilosec, and Zegerid, are available without a prescription. These drugs have been very effective in reducing stomach acid, more so than simple antacids (e.g., Maalox, Mylanta, Rolaids, and Tums) and also H2RA drugs (e.g., Axid, Pepcid, Tagamet, and Zantac). Because these drugs are so powerful and effective, many patients have requested them even when their symptoms are relatively mild or moderate. While PPIs were intended to treat serious conditions, those suffering from simple heartburn frequently take the drugs without considering the risks.
In light of this news, Joyce Korvick, deputy director for safety in the FDA’s Division of Gastroenterology Products, has stated that healthcare providers should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition. Doctors may also choose to prescribe alternative medications that do not pose the same risk of fractures, depending on the proposed use and duration of the treatment. In regards to PPIs, the FDA has issued the following advice:
· If your doctor recommended that you take a PPI, don’t stop taking the medication until you discuss it further with him or her.
· The greatest risk from PPIs is among people who take high doses or remain on the drugs for a year or more.
· Over-the-counter PPIs should be taken for only 14 days for treatment of frequent heartburn. No more than three 14-day courses should be taken in a single year.
· Discuss any concerns you may have about taking PPIs with your doctor.
Drugs manufacturers will change insert labels to disclose the possible increased risk of bone fractures. To report any side effects or product problems from medications, please contact the FDA’s MedWatch Adverse Event Reporting Program online or by phone at (800) 332-1088. While these drugs may provide relief for heartburn, be sure to weigh the benefits against the risks before starting a course of treatment with PPIs.