Acid Reflux Drugs: Public Citizen Petitions FDA for Stricter Warnings

Aug. 23, 2011— -- The watchdog group Public Citizen is calling for stricter warnings on popular acid reflux drugs called proton pump inhibitors.

In a petition filed today, Public Citizen urged the U.S. Food and Drug Administration to require a black box warning -- the strongest warning possible -- on the drugs' packaging detailing their side effects and potential to cause dependence among users.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said he hopes stricter warnings will curb unnecessary use of the drugs.

"These drugs have a use, but they're grossly overused," Wolfe said. "We hope use will go down when doctors and patients know the risks."

Some such risks, including bone fractures, infections and heart rhythm abnormalities, are listed in fine print on the drugs' packaging. But the potential for the drugs to exacerbate acid reflux when patients discontinue use -- a relatively recent observation -- is not.

"There's absolutely no warning that these drugs can cause dependence," Wolfe said, adding that he hopes a black box warning will prompt doctors and patients to consider other, safer options first.

Proton pump inhibitors, such as Nexium, Protonix and a slew of generic versions, are approved to treat heartburn, gastroesophageal reflux disease and gastric ulcers. But up to two-thirds of people using the drugs fail to meet those diagnostic criteria, according to a 2009 study published in the journal Alimentary Pharmacology & Therapeutics. And often less intensive treatments, such as antacids, can soothe symptoms sufficiently.

"It's absolutely true that too many people are on these medications," said Dr. Jacqueline Wolf, a gastroenterologist and associate professor of medicine at Harvard Medical School. "I think lifestyle changes can make a big difference in patients' symptoms."

Quitting smoking, losing weight, and avoiding certain foods, such as garlic, onions, coffee and carbonated beverages, can help minimize symptoms, Wolf said.

"I think physicians need to be aware of the medications' risks and get patients to try to change lifestyle changes and antacids first," Wolf said. "I absolutely agree we need to taper off these drugs."