On August 23, 2011, Public Citizen, a research-based advocacy group, called for stricter warnings on popular acid reflux drugs called proton pump inhibitors. In a petition filed, Public Citizen urged the U.S. Food and Drug Administration to require black box warnings, the strongest warning possible, on acid reflux drug 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. Dr. Wolfe states, “These drugs have a use, but they’re grossly overused. We hope use will go down when doctors and patients know the risks.”
Dr. Wolfe adds, “There’s absolutely no warning that these drugs can cause dependence.” He hopes a black box warning will prompt doctors and patients to consider other, safer options first.
Why Proton Pump Inhibitors are prescribed
Proton pump inhibitors, such as Nexium, Protonix, Prilosec, Prevacid, Aciphex, Dexilant, and several generic versions, are approved to treat heartburn, gastro esophageal reflux disease, and gastric ulcers.
Some risks associated with proton pump inhibitors use include bone fractures, infections, and heart rhythm abnormalities. These risks are listed in fine print on the drugs’ packaging.
Some options to consider
Take less intensive treatments first, such as antacids, which can soothe symptoms sufficiently.
Making lifestyle changes can make a big difference in symptoms. Changes such as quitting smoking, losing weight, and avoiding certain foods, such as garlic, onions, hot and spicy, fried, tomato sauce, certain fruits, coffee, and carbonated beverages, can help minimize symptoms.
Physicians need to be aware of the medications’ risks and educate their patients to try to make lifestyle changes and to try antacids first.
Public Citizen Calls for Stricter Warnings on Acid Reflux Drugs
A 2009 study published in Gastroenterology found that proton pump inhibitors could provoke reflux disease when healthy people stopped taking them. This is a discovery that could tilt the risk-benefit balance for patients who don’t need the drugs.
Dr. Wolfe of Public Citizen states, “Since over half the people using these drugs don’t even have conditions that warrant their use, you’re essentially causing acid reflux disease. We want doctors to know that, for some patients, these drugs are possibly causing more harm than good.” He feels that doctors overprescribe proton pump inhibitors.
Dr. Jacqueline Wolf, a gastroenterologist and associate professor of medicine at Harvard Medical School, feels that it is really important that pharmacies and doctors’ offices are educated information regarding lifestyle changes, guiding patients on what they should start with, and when to see a physician.
Public Citizen petitions to the FDA that the black box warnings include:
- Rebound acid hyper secretion risk
- Fracture risk
- Infection risk
- Magnesium deficiency risk
Public Citizen petitions to the FDA that label changes include:
- Drug-drug interactions
- Vitamin B12 deficiency
- Acute interstitial nephritis
- GERD-treatment length consistency
Public Citizen urges the FDA to:
- Require the distribution of FDA-approved Medication Guides for patients, containing these adverse effect warnings and describing alternatives to proton pump inhibitors use for all patients, to be dispensed when prescriptions are filled.
- Ask the sponsors of all proton pump inhibitor medications to send a “Dear Doctor” letter alerting physicians to these adverse effects and to include information on appropriate prescribing of proton pump inhibitors in inpatient and outpatient settings.