Stomach Acid-Blocking Drugs to Carry Warning About Extended Use

Prescription drugs that treat stomach ulcers and other gastric conditions by reducing the production of stomach acid will carry a new warning that long-term use may cause low magnesium levels in the blood.

The move, announced by the Food and Drug Administration, applies to prescriptions for “proton pump inhibitors,” or PPIs, such as Nexium, Prevacid and Prilosec. In 2009, the FDA said, 21 million patients filled PPI prescriptions at U.S. retail pharmacies. The drugs are often prescribed for stomach ulcers and acid reflux, also known as gastroesophageal reflux disease.

In a news release, the FDA said the drugs may lead to low magnesium levels if taken “for prolonged periods” — generally meaning more than a year, although the problem has been reported among people taking the medication for only three months. Low magnesium can lead to complications such as muscle spasms, irregular heartbeat and seizures.

According to the FDA, patients who take prescription PPIs continue for an average of about 180 days. The new warning does not apply to over-the-counter versions, which the FDA said are marketed at low doses and are intended for only a 14-day course of treatment, up to three times per year.

Regulators decided to issue the warning after reviewing reports from the FDA’s Adverse Event Reporting System database and medical journals. The FDA speculated that the drugs might interfere with intestinal absorption of magnesium.

Separately, a new study published in the journal PloS ONE found that the use of proton pump inhibitors by HIV-positive men increased their risk of bone fractures.

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