Consumer watchdog group Public Citizen, founded by Ralph Nader, is calling for stricter warnings on popular acid reflux drugs called proton pump inhibitors (“PPI”). Brand name PPIs include: Prilosec, Prevacid, and Nexium. Public Citizen is petitioning the FDA to add a warning regarding the potential for the drugs to make acid reflux worse when patients stop using the drug.
The petition filed on August 23, 2011 urges the U.S. Food and Drug Administration to require a black box warning on the drugs’ packaging detailing their side effects and potential to cause dependence among users.
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.
The petition requests the FDA to require the inclusion of black box warnings identifying the following risks for all prescription PPIs (and equivalent, prominent warnings for over-the-counter [OTC] PPIs): rebound acid hypersecretion risk, Fracture risk, Infection risk, and Magnesium deficiency risk.
In addition to the black box warnings, they’d like the FDA to require the following label changes for all PPIs: Drug-drug interactions, Vitamin B12 deficiency, Acute interstitial nephritis, and GERD-treatment length consistency:
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.” “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.
The petition states, “For the past 20 years, PPIs have become increasingly popular, partly because of their ability to relieve acid-related symptoms, and are now one of the most widely used classes of drugs in the U.S., with 119 million prescriptions dispensed in 2009.”
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.
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 over prescribe 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.
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 has successfully lobbied for black box warnings in the past.