FDA Adds Serious Warning To Heartburn Treatment Drug Reglan

Armen Hareyan's picture

The U.S. Food and Drug Administration's most serious warning will be added to the heartburn drug metoclopramide (brand name Reglan), which has been shown to cause muscle spasms and tics when used for long periods or at high doses, the FDA said.

These problems, including uncontrollable movement of the limbs, face and tongue, are usually irreversible even after patients stop taking the drug, according to the warning, cited by the Associated Press.

The drug is marketed by Schwarz Pharma (tablet form), Baxter International (injectable form) and by a number of generic drug makers. In addition to the black box warning, all manufacturers will be required to provide medication safety guides to users.

More than 2 million people in the United States use metoclopramide, which works by speeding up the muscles used in digestion and relieving painful stomach acid reflux, the AP reported.


"The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

Important things you need to know about heartburn

Three Over The Counter Heartburn Treatment Drugs Described By Mayo Clinic

Antacids. Antacids, such as Maalox, Mylanta, Gelusil, Rolaids and Tums, neutralize stomach acid and can provide quick relief. But antacids alone won't heal an inflamed esophagus damaged by stomach acid. Overuse of some antacids can cause side effects such as diarrhea or constipation.

H-2-receptor blockers. Over-the-counter H-2-receptor blockers, such as cimetidine (Tagamet HB), famotidine (Pepcid AC), nizatidine (Axid AR) or ranitidine (Zantac 75), are available at half the strength of their prescription versions. Instead of neutralizing the acid, these medications reduce the production of acid. They don't act as quickly as antacids, but they provide longer relief. Take these medications before a meal that you think may cause heartburn because it takes them about 30 minutes to work. They're also effective in reducing reflux at night if taken at bedtime. Some H-2-receptor blockers can cause infrequent side effects, including dizziness, diarrhea, headache, kidney problems and temporary breast enlargement in men. In rare instances they can also react dangerously with other medications.

Proton pump inhibitors. These medications block acid production and allow time for damaged esophageal tissue to heal. Omeprazole (Prilosec) was previously available only by prescription, but now is available in an over-the-counter form for the short-term treatment of heartburn.