FDA Is Petitioned To Add Black Boxes For PPIs

FDA Is Petitioned To Add Black Boxes For PPIs

August 25th, 2011 // 2:05 pm @ jmpickett

The widely used class of drug known as proton pump inhibitors that are used to treat acid reflux can cause dependency and, therefore, are likely to increase various serious risks, some of which are not specified in product labeling, according to Public Citizen. And so the consumer watchdog is petitioning the FDA to upgrade labeling for these meds with Black Box warnings.

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In making its case, Public Citizen notes that patients who use PPIs for at least a month, but then stop taking the med can have even more stomach acid, which is called rebound acid secretion. As a result, patients may return to the meds, creating what the watchdog group calls a “long-term dependence.” Yet some patients may not need the meds in the first place, Public Citizen argues.

“PPIs are often prescribed outside of their approved uses, for purposes such as stress ulcer prophylaxis in noncritical hospitalized patients and long-term treatment of conditions such as GERD past the approved time frame. It has been estimated that up to two-thirds of all people on PPIs do not have a verified indication for the drug. In addition, even in many people with presumed GERD on PPI therapy, less intense acid-suppressive therapies are effective in relieving symptoms, and in other cases, the medical problem does not even involve acid reflux,” the group writes in its petition.

“Compounding the problem of massive inappropriate use, recent evidence has documented several serious new safety problems with long-term PPI use. For some of these risks, current FDA-approved PPI labels do not mention the adverse effect at all, including the potential for developing dependence on the drugs, which results in rebound hypersecretion of stomach acid and recurrence of symptoms after stopping PPI use. For other risks, even if mentioned, the label does not adequately explain or emphasize them. There are currently no black box warnings in the label of any PPI” (you can read the petition here).

To bolster its cause, Public Citizen enlisted Helge Waldum, who heads of the Department of Digestive and Liver Diseases at Trondheim University Hospital in Norway and has authored dozens of medical journal articles on PPIs, including what is said to be the first trial to show patients could become dependent on the meds through the so-called rebound effect. He signed on as a co-petitioner (and you can read his statement here).

In response, a spokeswoman for AstraZeneca, which sells Nexium, Prilosec and Vimovo, wrote us this: “We work with the FDA to ensure the benefit/risk profile of our products are reflected appropriately in the prescribing information so that health care professionals can weigh the risk and benefit of medicines when making treatment decisions. PPIs have been available in the US for over 20 years and are among the most widely-studied class of medicines.

“The data referred to by Public Citizen is in the public domain and available to regulators and physicians across the world. Ultimately, it’s up to doctors to prescribe these medicines based on individual patient need. We encourage ongoing communication between physicians and patients concerning individual medical needs. AstraZeneca is confident in the positive benefit-riskand safety profiles of NEXIUM, PRILOSEC and VIMOVO.”

Source: Pharmalot