Public Citizen asks FDA for black box on PPIs

Public Citizen is petitioning the FDA for a "black box" warning on common stomach acid drugs such as AstraZeneca's ($AZN) Nexium and Prilosec and Pfizer's ($PFE) Protonix. The consumer watchdog group says these drugs--known as proton-pump inhibitors, or PPIs--can be habit-forming. Plus, they come with some serious long-term side effects, the group says.

According to Public Citizen, PPI therapy for a month or more can cause patients to produce even more stomach acid when they stop taking the drug. It's called "rebound acid hypersecretion," and it can make acid reflux symptoms worse than they were before therapy began. So, patients start taking the drugs again, "creating long-term dependence" on them.

The drugs were prescribed 119 million times in 2009 and accounted for $13.6 billion in U.S. sales, the group said. In fact, some 5% of people in the developed world take one PPI or another, including branded and generic versions. Public Citizen says that studies show up to two-thirds of people using these drugs don't have a condition they're designed to treat. In addition, people often take them for longer than recommended.

"These drugs are being prescribed far too commonly to people who shouldn't be taking them," Public Citizen's Health Research Director Sidney Wolfe said in a statement. "As a result, millions of people are needlessly setting themselves up to become dependent on PPIs while exposing themselves to the serious risks associated with long-term therapy."

The drugs do have some serious potential side effects, including an increase in fracture risk and an increase in the risk of certain infections. The risks are disclosed on the drugs' labels, but not as prominently as Public Citizen would like.

The Mayo Clinic's Kenneth DeVault, however, told Medscape Medical News that warnings aren't necessary, but better education is. Patients should be given the "lowest effective dose," for one thing, and should rely on diet and exercise to treat their acid reflux, too. "Honestly," DeVault said, "the risks of these medications, even when over the counter, are less than some other common drugs, such as nonsteroidal anti-inflammatories and even aspirin."

- see the statement from Public Citizen
- read the Medscape story