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FDA Medwatch Alert: Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs

Posted 8 Feb 2012 by Drugs.com

AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium) Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole) and OTC Protonix (pantoprazole sodium) Vimovo (esomeprazole magnesium and naproxen) Zegerid (omeprazole and Sodium bicarbonate) and OTC [Posted 02/08/2012] ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels. FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 rece ... Read more

Heartburn Drugs May Raise Fracture Risk in Older Women

Posted 31 Jan 2012 by Drugs.com

TUESDAY, Jan. 31 – Older women who take popular medications to control indigestion and heartburn may put themselves at higher risk for hip fractures, researchers report. Long-term use of these drugs, called proton pump inhibitors (PPIs), may increase that risk by 35 percent to 50 percent for current or former smokers, the researchers added. Prilosec, Nexium and Prevacid are some examples of these medications. "Although PPI use might be strongly indicated in some patients, at least for short-term use, we believe that clinicians should continue to carefully monitor the need for long-term use of these medications, specifically among postmenopausal women with a history of smoking," said lead researcher Dr. Hamed Khalili, a clinical and research fellow in gastroenterology at Massachusetts General Hospital in Boston. "Our data supports the recent decision by the U.S. Food and Drug ... Read more

Heartburn Meds Won't Help, May Harm Kids With Asthma

Posted 24 Jan 2012 by Drugs.com

TUESDAY, Jan. 24 – Children with asthma who don't have heartburn and other signs of gastroesophageal reflux don't get additional asthma control from acid-reducing medications, according to new research. And, taking these medications when there are no digestive issues increases a child's risk of developing a respiratory infection, reports the study. "There's a strong epidemiological link between acid reflux and asthma," explained study co-author Janet Holbrook, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. As a result, current asthma guidelines call for evaluating people with asthma for acid reflux, Holbrook said. Because definitive tests for excess acid production can cause children discomfort, some doctors may choose to do a trial of acid-suppressing medications called proton pump inhibitors (PPIs). Some common brand names ... Read more

Have Heartburn? Get Help

Posted 5 Jan 2012 by Drugs.com

THURSDAY, Jan. 5 – Susan Schneck began suffering from frequent, painful heartburn in 1998. "In the evening and especially after lying down to go to sleep, I would invariably experience heartburn," Schneck said. "It was a burning. Not exactly nausea, but that same type of upward sensation, only with that burning. Like you'd had a hot drink or really, really spicy food. And once it started, it wouldn't go away." It never occurred to Schneck, now 37 and living in Madison, Wis., to go to a doctor for treatment. "I kind of knew, 'Oh, it's heartburn.' It never occurred to me it could be something worse," she said. "It also never occurred to me it could be something I could fix." Instead, she dealt with the problem by chewing antacid tablets. "I'd never done anything but take Tums," she said. "I took two Tums a day, at least. Pretty much every day I experienced symptoms, and every day I had ... Read more

Related support groups: GERD, Nexium, Esomeprazole, Nexium IV

No One Treatment for Acid Reflux Clearly Better Than Another: Study

Posted 29 Sep 2011 by Drugs.com

THURSDAY, Sept. 29 – Medications are effective for most patients with acid reflux disease, but some surgical options may be just as effective, according to a review of studies on current treatments for this common condition. Acid reflux disease, also known as gastroesophageal reflux disease or GERD, occurs when the contents of the stomach – including burning acid – chronically spill up into the esophagus, causing heartburn and other symptoms such as a persistent cough, laryngitis and asthma. Acid reflux disease may afflict as many as 4 percent of Americans, resulting not only in a sometimes significant financial drain but also more serious long-term consequences such as esophageal cancer, according to background information in the report released Sept. 23 by the U.S. Agency for Healthcare Research & Quality (AHRQ), part of the U.S. Department of Health & Human Services. Obesity, ... Read more

Popular Heartburn Meds May Boost Fracture Risk

Posted 9 May 2011 by Drugs.com

MONDAY, May 9 – Reinforcing U.S. health officials' concerns, new Korean research suggests that long-term use of popular heartburn drugs such as Prilosec, Prevacid and Nexium is linked to an increased risk of fractures. Scientists conducting a meta-analysis of 11 studies published between 1997 and 2011 found that proton pump inhibitors (PPIs), which reduce stomach acid production, were associated with a 29 percent increased risk of fracture. This included a 31 percent higher risk of hip fractures and a 54 percent heightened risk of vertebral fractures. Another class of heartburn drugs known as H2-receptor antagonists or H2 blockers – which include brand names such as Zantac and Pepcid – were not significantly linked to fracture risk, according to the study authors. H2 blockers, however, are less powerful than PPIs at suppressing acid production, blocking only about 70 percent rather ... Read more

FDA Drug Safety Communication: Low Magnesium Levels Can be Associated with Long-term Use of Proton Pump Inhibitor Drugs (PPIs)

Posted 3 Mar 2011 by Drugs.com

Silver Spring, Md., March 2, 2011--The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued. PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. In 2009, approximately 21 million patients filled PPI prescriptions at outpatient retail pharmacies in the United States.2 Patients who take prescription PPIs usually stay on therapy for an average of about 180 days (6 months).3 Prescription ... Read more

Heartburn Drugs May Raise Pneumonia Risk

Posted 21 Dec 2010 by Drugs.com

MONDAY, Dec. 20 – Popular heartburn drugs, including proton pump inhibitors and histamine-2 receptor antagonists, may raise the risk of pneumonia, new research finds. Researchers in Korea analyzed the results of 31 studies on heartburn drugs published between 1985 and 2009. "Our results suggest that the use of acid suppressive drugs is associated with an increased risk of pneumonia," said Dr. Sang Min Park of the department of family medicine at Seoul National University Hospital in Korea. "Patients should be cautious at overuse of acid-suppressive drugs, both high-dose and long duration," he added. Sales of these enormously popular drugs – the second best-selling category of medications worldwide – reached nearly $27 billion in the United States in 2005, according to background information in the study, published Dec. 20 in CMAJ (Canadian Medical Association Journal). Proton pump ... Read more

No Link Between Heartburn Drugs and Birth Defects: Study

Posted 24 Nov 2010 by Drugs.com

WEDNESDAY, Nov. 24 – Babies born to women who took a popular class of heartburn drugs while they were pregnant did not appear to have any heightened risk of birth defects, a large Danish study finds. This class of drugs, known as proton-pump inhibitors (PPIs), include blockbusters such as Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). All were available by prescription-only during most of the study period (1996-2008), but Prilosec and Prevacid are now sold over-the-counter. While the authors and an editorialist, publishing in the Nov. 25 issue of the New England Journal of Medicine, called the results "reassuring," experts still recommend using drugs as little as possible during pregnancy. "In general, these are probably safe but it takes a lot of time and a lot of exposures before you see some of the abnormalities that might exist," explained Dr. Eva ... Read more

Heartburn Drugs, Plavix Seem Safe to Take Together

Posted 6 Oct 2010 by Drugs.com

WEDNESDAY, Oct. 6 – Heartburn drugs known as proton-pump inhibitors can safely be taken with the blood thinner Plavix, a new study indicates. There has been concern that these medications, called PPIs, might interfere with the ability of Plavix (clopidogrel) to do its job. "This is reassuring data that there is not any clinically significant interaction between clopidogrel and PPIs," said lead researcher Dr. Deepak L. Bhatt, chief of cardiology at the Veterans Affairs Boston Healthcare System. "This is contrary to prior observational, non-randomized studies that showed that if you took clopidogrel and a PPI, it blunted the ability of clopidogrel to protect from things like heart attack," he noted. In addition, this is the first randomized clinical trial to show that prophylactic use of PPIs for patients taking Plavix reduces gastrointestinal bleeding, he said. Doctors often prescribe ... Read more

Plavix, Heartburn Drug Safe to Take Together: Study

Posted 21 Sep 2010 by Drugs.com

TUESDAY, Sept. 21 – A new study finds it's safe to take the blood thinner Plavix with proton-pump inhibitors like Nexium, contrary to recent research that said the combination compromised Plavix's effectiveness. "We looked into this highly debated area of clopidogrel [Plavix] and proton-pump inhibitors," said lead researcher Dr. Mette Charlot from the department of cardiology at Copenhagen University Hospital Gentofte in Hellerup, Denmark. "We did not find any evidence of drug interaction." Proton-pump inhibitors are heartburn drugs. Doctors often prescribe the two drugs in combination to prevent clotting and reduce the risk of stomach bleeding, which can be a serious complication for patients taking Plavix, the researchers said. This study is larger than studies that found an interaction between the drugs, and this data included patients who were taking PPIs but not Plavix, Charlot ... Read more

FDA Warns of Fracture Risk With Popular Heartburn Drugs

Posted 26 May 2010 by Drugs.com

TUESDAY, May 25 – Blockbuster heartburn medications such as Prevacid, Prilosec and Nexium will now carry a warning on their labels linking the drugs to a heightened risk for fractures, the U.S. Food and Drug Administration announced late Tuesday. The label will advise consumers to use this class of medicines, called proton pump inhibitors (PPIs), carefully, because high doses have been associated with an increased risk of fractures of the hip, wrist and spine, the agency said. PPIs, which include prescription and over-the-counter drugs, work by blocking stomach acid from being produced. However, as with any drug, this benefit comes with some risk, the FDA said. "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," Dr. Joyce Korvick, deputy director for safety in FDA's Division of ... Read more

Stomach Acid Drugs Come with Dangers, Studies Show

Posted 10 May 2010 by Drugs.com

MONDAY, May 10 – Proton pump inhibitors such as Prilosec and Nexium are among the most commonly prescribed drugs in the United States, but several new studies warn that the popular stomach acid reducers are showing the potential for serious side effects. Five studies and an editorial in the May issue of the Archives of Internal Medicine explore the side effects associated with proton pump inhibitors, including bone fractures among older women and Clostridium difficile infections that can cause life-threatening diarrhea and gastrointestinal upset in older people. Overall, proton pump inhibitors are safe, experts stressed. Even so, evidence suggests the drugs are being prescribed unnecessarily and that potential side effects are not being taken seriously enough. "Generally speaking, proton pump inhibitors are safe medications. Proton pump inhibitors are commonly used and generally very ... Read more

Reflux Drugs OK With Blood Thinners

Posted 12 Jan 2010 by Drugs.com

TUESDAY, Sept. 1 – Antacids don't interfere with anti-clotting drugs such as Plavix and Effient in patients who have suffered a heart attack or unstable angina, a new study finds. The results counter other studies that concluded that a class of antacids known as proton pump inhibitors (PPIs) could block the effect of anti-clotting drugs. Doctors often prescribe PPIs along with anti-clotting drugs to reduce the risk of gastrointestinal bleeding. "The current findings provide some reassurance to clinicians that PPIs and clopidogrel [Plavix] can be safely combined in patients in whom there is a strong indication to use both drugs," said lead researcher Dr. Michelle O'Donoghue, an investigator in the TIMI Study Group at Brigham and Women's Hospital in Boston. As to why the findings differ from earlier results, O'Donoghue said the answer may lie in the patients themselves and in the type of ... Read more

Right Match of Drug, Doctor Can Boost Reflux Outcomes

Posted 12 Jan 2010 by Drugs.com

FRIDAY, Aug. 21 – Chronic heartburn caused by acid reflux is one of the most common complaints among Americans, and a new study outlines which approaches appear to work best to ease patients' suffering. The Danish study found that people with the condition – formally called gastroesophageal reflux disease (GERD) – typically feel best when placed on medications called proton pump inhibitors (PPIs) by a doctor with whom they have a good rapport. "The treatment we have isn't always perfect," conceded Dr. Maria T. Abreu, professor of medicine and chief of the division of gastroenterology at the University of Miami Miller School of Medicine, who was not involved in the study. She agreed that communicating well with patients can go a long way toward increasing their satisfaction, because reflux treatments don't always relieve all symptoms. If doctors said that up front, patients "might be ... Read more

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GERD, Barrett's Esophagus, Erosive Esophagitis, Helicobacter Pylori Infection, NSAID-Induced Gastric Ulcer, Duodenal Ulcer Prophylaxis, Zollinger-Ellison Syndrome, Pathological Hypersecretory Conditions