Published: Apr 30, 2014
By Elbert Chu
The FDA failed to respond to a 2011 petition demanding strong warnings about proton pump inhibitors (PPIs), according to a Public Citizen’s lawsuit filed today.
Public Citizen’s lawsuit seeks a ruling from the U.S. District Court of the District of Columbia that the FDA unlawfully withheld action, and calls for an order for the FDA to act within 30 days.
“In general, it’s a slow moving bureaucracy,” said David Gortler, PharmD, former FDA senior medical officer and professor of pharmacology at Georgetown University School of Medicine. “For better or for worse, the FDA is very thorough, but slow in their safety analyses.”
Evidence has shown PPIs increase the risk of severe side-effects such as hip fractures, life-threatening cardiac arrhythmias, and C. difficile infections. The FDA revised labeling requirements in 2010 to include the fracture risk. But Public Citizen claims current warnings for all the risks are not displayed prominently.
In addition, a 2009 study in Gastroenterology found PPIs may have caused patients to have acid-reflux — the problem they were meant to treat. Called the rebound effect, the researchers said the increase in acid could trigger dependence for the drugs, but it’s not listed as a potential problem.
Although other research such as a meta-analysis in 2011 appeared to counter those findings, Gortler said the rebound effect with over-the-counter antacids is “indisputable and ubiquitous throughout the medical literature.”
The FDA said it does not comment on pending litigation. AstraZeneca, which markets PPI market-leader Nexium, did not respond to MedPage Today’s requests for comment.
The FDA approved the PPIs for patients diagnosed with gastroesophageal reflux disease (GERD), among other indications. These drugs were intended for, and work best for short term control — 1 or 2 days — of GERD, Gortler told MedPage Today. He added that in rare cases of ulcers or erosive disease they can actually be used for 1 month or more and in H. pylori infections, the regimen is 7 to 10 days, in combination with antibiotics.
PPIs include:
- Nexium/Nexium 24HR
- Dexilant
- Prilosec/Prilosec OTC
- Zegerid/Zegerid OTC
- Prevacid/Prevacid 24-Hr
- Protonix
- AcipHex
- Vimovo
- Numerous generic counterparts, such as omeprazole and pantoprazole
The problem is that the drug became widely taken by people chronically, and that has led potentially to lifetime dependence to PPIs, Gortler said.
“Millions of people are taking these drugs without adequate warnings,” said Sidney Wolfe, MD, founder and senior adviser to Public Citizen’s Health Research Group, in a press release.
However, Gortler said the blame is not solely the FDA’s. “There’s the failure of prescribers to note the intention for acute use, and drug manufacturers spent millions on advertising, not clearly specifying short-term usage.”
The original petition called for black box warnings, a “Dear Doctor” letter, and a requirement for “sufficiently informative Medication Guides” to accompany the PPI prescriptions dispensed, which totaled 131 million in 2013, according to consumer watchdog group, Public Citizen.
“At this point, there’s no urgency with the FDA responding, seeing as so many people out there take PPIs and now perhaps are already dependent,” Gortler said. “They should have done something a long time ago.” He added that the FDA’s surveillance data from many years ago would have noted patients were inappropriately taking PPIs on a long-term basis.