According to Business Wire, a new study published in the Journal of Clinical Pharmacology has found that since proton pump inhibitors (PPIs) such as Prevacid and Prilosec became available over-the-counter (OTC) in 2004, gastroesophageal reflux disease (GERD) related visits to emergency rooms, hospital clinics and office-based clinics, which had been rising in the prior decade, were significantly reduced and have remained stable in the years following.
“The availability of effective OTC medications for common conditions may be advantageous for the U.S. health care system by reducing the number of nonessential physician visits, while creating a more rational allocation of health care resources to manage more serious conditions and other health care priorities,” said study author Dong Chang, MD, of the Division of Respiratory and Critical Care Physiology and Medicine from the Los Angeles Biomed Research Institute, University of California at Los Angeles Medical Center according to Business Wire.
This “Good for Patients, but Also Good for Doctors, Emergency Rooms, and Health Systems,” take is dependent on the assumption of the safety of the drugs in question. The Business Wire article goes on to explain that: “For a medicine to be granted OTC status, it must have a wide safety margin and be effective, and must bear understandable labeling to ensure proper use.”
However, not all experts agree about the safety of PPIs and research has shown that they are often not used appropriately even by physicians who should be up to date about the risks of prolonged exposure to PPIs that are being published in academic journals around the world. In 2013, an estimated 15 million Americans were prescribed PPIs, according to Nephrology News, and those were the ones who were still getting prescriptions. According to this new study, many who used to seek attention from medical professionals are now self diagnosing and treating with OTC PPIs.
WebMD says: “The drugs already carry warnings for several known risks, including C. difficile infections, which can cause chronic diarrhea; pneumonia; low magnesium levels, which can cause muscle spasms; heart palpitations and convulsions; and fractures of the hip, wrist, or spine.” The drugs have also been linked to increased risk of dementia, heart attack, cancers of the esophagus and stomach, and increased risk of chronic kidney disease and kidney failure.
Researcher John Cooke, MD, PhD, Chair of Cardiovascular Disease Research at Houston Methodist Hospital, told WebMD, “They should be pulled off the shelves. They should be by prescription and they should be medically monitored because of the risks.”
Many of those risks increase with prolonged use of the drugs. “Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” said Joyce Korvick, M.D., deputy director for safety in FDA’s Division of Gastroenterology Products in a press announcement in 2010. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
However, the use of the drugs is often not limited to less than a year. In a study just published this month by German researchers that found many GERD patients were still suffering from symptoms and unhappy with their PPI treatment, of the 323 patients questioned, the average amount of time on PPIs was 6.26 years. All patients in the study had been on PPIs for more than a year.
These are patients who have been prescribed PPIs. Those who are self-diagnosing and treating are perhaps even more likely to find themselves taking the drugs longer than recommended, as researchers have found that it can be very difficult for users to quit the therapy. When PPI users try to stop the treatment they may have rebound stomach acid production called “rebound acid hypersecretion.” This is one of many problems mentioned in an article published by the National Center for Biotechnology Information (NCBI) in 2014 titled “Overutilization of proton-pump inhibitors: what the clinician needs to know.”
OTC PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to three times per year, whereas prescription PPIs are often taken for much longer periods of time under a doctor’s supervision. It is not improbable to imagine that patients switching from prescription to OTC are liable to disregard the label’s safety recommendations and continue using it the way they were accustomed to when under a doctor’s care, being unaware of all the risks that come with prolonged use.
This new information about people taking a burden off the health care system by treating themselves with OTC PPIs might be less obviously positive than it at first seems.
U.S. Food and Drug Administration
National Center for Biotechnology Information
US National Library of Medicine National Institutes of Health