Acid Reflux Drugs: Public Citizen Petitions FDA for Stricter Warnings

Public Citizen petitioned the FDA for black box warnings, citing serious risks.

August 23, 2011, 3:18 PM

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."

Public Citizen Calls for Stricter Warnings on Acid Reflux Drugs

A 2009 study published in Gastroenterology found that proton pump inhibitors could actually provoke reflux disease when healthy people stopped taking them. a discovery that could tilt the risk-benefit balance for patients who don't need the drugs.

"Since over half the people using these drugs don't even have conditions that warrant their use, you're essentially causing acid reflux disease," Public Citizen's Wolfe said of doctors who overprescribe proton pump inhibitors. "We want doctors to know that, for some patients, these drugs are possibly causing more harm than good."

Proton pump inhibitors are the third highest-selling class of drugs in the United States. Nexium, made by AstraZeneca, has the second highest retail sales among all drugs -- $4.8 billion in 2008. Some brands, such as Prilosec and Zegerid, are available in over-the-counter form.

"I think it's really important that we have educational information in pharmacies and in doctor's offices that speaks to lifestyle changes and guide patients on what they should start with and when to see a doctor," said Harvard's Wolf.

The Public Citizen petition calls for black box warnings on prescription and over-the-counter proton pump inhibitors. A spokeswoman for the FDA declined to comment on the petition, saying only that the department would review it and respond to the organization that submitted it.

Public Citizen successfully lobbied the FDA in 2009 to add a black box warning to Botox, citing the potential for the product to spread from the point of injection and cause breathing and swallowing problems.

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