Yourlawyer.com (Prilosec News)

FDA Warns PPIs May Cause Severe Diarrheal Infection

Thu, 09 Feb 2012 00:00:00 -0500

Patients who take proton pump inhibitors (PPIs) may be at a higher risk of developing a serious condition called Clostridium difficile–associated diarrhea (CDAD). The danger prompted the U.S. Food & Drug Administration (FDA) to issue a Drug Safety Communication yesterday, and announce that it was working with the makers of PPIs to add information about their association with CDAD to the drug's labels.

CDAD is a type of diarrhea that does not improved. It is caused by Clostridium difficile (C. diff), a bacteria often spread in hospitals, which can be passed from person-to-¬person on contaminated equipment and on the hands of doctors, nurses, other healthcare providers and visitors. The condition can be treated with antibiotics, but often the most severe cases of C. diff infection require surgery.

In its Drug Safety Communication, the FDA advised healthcare providers to

Consider a CDAD diagnosis for PPI users with diarrhea that does not improve.
Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Report adverse events involving PPIs to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

Patients should seek care immediately if they develop diarrhea that does not improve.

PPIs are sold as both prescription and over-the-counter (OTC) medications. Prescription PPIs (Dexilant, Nexium, Prevacid, Prilosec, Protonix, Vimovo and Zegerid) are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs (Prilosec OTC, Prevacid 24hr and Zegerid OTC) are used to treat frequent heartburn.

Older Women Face Hip Fracture Risk from PPIs

Wed, 01 Feb 2012 00:00:00 -0500

Post-menopausal women, especially if they smoke, might want to think twice about taking a proton pump inhibitor (PPI) to relieve heartburn. According to a new study in the British Medical Journal (BMJ), post-menopausal women who take PPIs like Nexium, Prilosec and Prevacid for two years or more increase their risk of sustaining a hip fracture by 35 percent.

The study also found that women who took the PPIs for six to eight years were 50 percent more likely to suffer a broken hip. Postmenopausal women with history of smoking who took PPIs for longer than two years had more than a 50 percent chance of sustaining a hip fracture. The researchers suggest that the inhibition of calcium absorption from smoking may act with PPIs to increase fracture risk.

The risk of hip fracture returned to normal two years after women stopped taking proton pump inhibitors, the researchers said.

The study, conducted by researchers from Massachusetts General Hospital, involved data on nearly 80,000 U.S. women enrolled in the Nurses Health Study between the ages of 33 and 55. A total of 893 hip fractures were recorded during the time period the women were followed. According to the research team conducting the study, the use of PPIs among the women followed increased nearly 3-fold from 2000 to 2008 among the women in the study, from 6.7% to 18.9%.

The BMJ study is just the latest to point to an association between PPIs and fractures. In May 2010, the U.S. Food & Drug Administration (FDA) announced new information on fractures was being added to the labels of prescription PPIs after a review of several epidemiological studies reported an increased risk of fractures of the hip, wrist, and spine with PPI use.

Plavix, Proton Pump Inhibitor Warnings Revised in Canada

Fri, 23 Sep 2011 00:00:00 -0400

Health Canada is revising the label for Plavix in that country to reflect new information about the concurrent use of the blood thinner and other drugs called proton pump inhibitors (PPIs).   Many Plavix users take PPIs to counteract the ulcers and heartburn that can accompany use of the blood thinner.

In 2009, Health Canada updated the labels for ALL PPIs to recommend they not be used with Plavix, after some research indicated that the drugs could reduce the efficacy of Plavix. But according to a statement issued yesterday, new studies indicate that not all PPIs impact Plavix in the same way. Health Canada is now recommending that:

•    PPIs known to strongly or moderately reduce Plavix effectiveness should be avoided. Omeprazole (sold as Losec in Canada, and as Prilosec in the U.S.) is one of these.
•    If a PPI must be used in a patient taking Plavix, consider a PPI that does not interact as strongly. Pantoprazole is one of these.

In addition to omeprazole, the new Health Canada recommendations apply to the following PPIs:

•    Dexilant (dexlansoprazole)
•    Nexium (esomeprazole)
•    Prevacid (lansoprazole)
•    Pantoloc and Panto IV (pantoprazole, sold as Protonix in the U.S.)
•    Tecta (pantoprazole/magnesium)
•    Pariet (rabeprazole, sold as Aciphex in the U.S.

PPIs are also available in combination with other drugs, for example Vimovo, which contains Nexium.

In 2009, the U.S. Food & Drug Administration (FDA) recommended that patients taking Plavix avoid Nexium and Prilosec because they could reduce the effectiveness of Plavix. At the time, the agency said it was not known how other PPIs would impact Plavix. The FDA also recommended that Plavix patients who needed relief from heartburn consider other drugs that don't interfere with its efficacy, including Maalox or Mylanta, Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine).

Hip Fracture Risk Higher in Older Women on Proton Pump Inhibitors

Wed, 08 Jun 2011 00:00:00 -0400

A study presented last month at the annual Digestive Disease Week in Chicago has confirmed that long-term use of proton pump inhibitors, such as Nexium, increases the risk of hip fractures in post-menopausal women. According to Internal Medicine News, the study also found that the hip fracture risk was higher among women who used the popular heart burn drugs, even when adjusting for other risk factors including vitamin D intake; history of osteoporosis; and use of hormone replacement therapy, bisphosphonates, and thiazides.

Previous smaller studies indicating that long-term use of proton pump inhibitors increased fracture risk in this patient population prompted the U.S. Food & Drug Administration to add warnings to their labels last year. But according to Internal Medicine News, other "analyses have mostly been based on retrospective studies of small populations that have not controlled for important dietary and lifestyle confounders." The authors of this new study, which involved 79,899 postmenopausal women enrolled in the Nurses’ Health Study, wanted to reach a more definitive conclusion by "prospectively examining the relationship between chronic PPI use and incident hip fracture."

The women in the study were first asked about fractures in 1982, and were followed up about new fractures on a biennial basis. According to the study authors, there were 893 incident hip fractures over 8 years. Proton pump inhibitor use was reported by 7% of participants in 2000 and by 19% of participants in 2008.

According to Internal Medicine News, the researchers found that:

In comparing the risk of hip fractures in women who took proton pump inhibitors versus those who did not, the risk for those taking the drugs rose to 6% after 2 years of use, 42% after 4 years and 54% when proton pump inhibitors were used for 6 years or longer.
Regular use of drugs posed fracture risks of 35%-45% when adjusted for age, calcium intake, and body mass index.
Discontinuing use of the drugs reduced fracture risk. Two or more years after discontinuation, the risk of hip fracture was just 9%-10%.
Of the other risk factors taken into account, only smoking had any impact. Current or past smokers and who regularly took a proton pump inhibitors had a 51% increased risk for fracture, compared to 6% in nonsmokers.

According to Internal Medicine News, the study was received well at the Digestive Disease Week conference, with attendees calling it "truly excellent work" and "impressive."

Heartburn Drugs May Up Risk of C. Difficile by 80 Percent

Mon, 08 Nov 2010 00:00:00 -0500

A new study suggests that taking proton pump inhibitors could increase the risk of contracting Clostridium difficile–associated diarrhea (CDAD) by as much as 80 percent. C. difficile represents an escalating threat to public health, and CDAD cost the US an estimated $3 billion in 2005.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach, and are approved to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. OTC brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR. Since their introduction in the 90s, proton pumps have ranked among the top selling drugs, with doctors writing 119 million prescriptions for them last year alone.

For this new study, researchers looked at data from 21 peer-reviewed published studies. The 7 cohort studies and 14 case-control studies included 133,054 individuals. Overall, there was a significant increase in the risk of CDAD in patients taking proton pump inhibitors (risk estimate, 1.80). The risk estimate in the case-control studies was 1.55 and in the cohort studies 2.07. The CDAD risk was significantly higher for patients taking proton pump inhibitors whether the types of studies were considered separately or as a whole.

According to one of the study’s authors, Dr. Sailajah Janarthanan of Wayne State University in Detroit, proton pump inhibitors have faced scrutiny for a possible association with CDAD, but results from previous studies have yielded mixed results. She noted that even a slight increase in the risk of CDAD conferred by these drugs will have major public health implications, considering how many people use proton pump inhibitors.

“Indiscriminate use of PPIs (proton pump inhibitors) without proper indication should be discouraged,” she wrote. “There is a real-time need for guidelines on the use of PPIs, especially in hospitals.”

Dr. Janarthanan and her colleagues did note that the studies they reviewed were limited by the lack of randomized, controlled trials, and that the impact of proton pump inhibitors on CDAD remains controversial.

Another Plavix - Prilosec Warning Coming from FDA

Wed, 20 Oct 2010 00:00:00 -0400

Plavix (clopidogrel) users will again be cautioned not to take the proton pump inhibitor Prilosec by the US Food & Drug Administration (FDA), according to a report in The Wall Street Journal. The agency still has concerns that Prilosec can inhibit the ability of Plavix to prevent blood clots.

Proton pump inhibitors like Prilosec are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. Last November, the FDA first warned that people taking Plavix should avoid Prilosec because of data indicating the heartburn drugs could interfere with the effectiveness of Plavix. In March, a black-box warning – the FDA’s strongest safety warning – was added to Plavix’s label warning of “diminished effectiveness” in patients who metabolize the drug poorly, including those who take Prilosec.

According to The Wall Street Journal, a study published this month in The New England Journal of Medicine suggested patients taking both drugs were at no greater risk of serious cardiovascular events than those taking Plavix alone.

After the study was published, Mary Ross Southworth, an FDA official overseeing the safety of cardiovascular products, told the Journal that some doctors may have misinterpreted that study. She and Ellis Unger, a colleague at the FDA, maintained that the study was too small to be meaningful and used a delayed-release version of Prilosec that is not available to patients.

Now, according to the Journal, Southworth and Unger said the FDA is concerned that the study published this month will lead doctors and patients to make what they described as the wrong decision. As such, the agency plans to issue a reminder to doctors and other health-care providers about the possible risks of taking Prilosec along with Plavix.

The Wall Street Journal also points out some interesting facts about the recent study – called Cogent- that is causing the FDA so much concern:

“The original sponsor of the Cogent study, Cogentus Pharmaceuticals Inc., went bankrupt in early 2009. Cogentus’s major product in development was a drug that essentially combines Plavix and a form of Prilosec.

According to The Wall Street Journal, Cogent was finished partly through voluntary work by researchers who didn’t want their early efforts wasted.

Plavix Users Warned Not to Take Prilosec, Nexium

Wed, 18 Nov 2009 00:00:00 -0500

Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA). As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. New studies compared the amount of Plavix's active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.

Prilosec is one of a class of drugs known as Proton Pump Inhibitors (PPIs). PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of inhibition among other PPIs varies, so it is unknown to what extent other PPIs may interfere with Plavix. However, Nexium, a PPI that is a component of Prilosec, also inhibits CYP2C19 and should also be avoided in combination with Plavix.

The FDA also advised that other drugs that are potent inhibitors of the CYP 2C19 enzyme would be expected to have a similar effect and should be avoided in combination with Plavix. These include: Tagamet, Diflucan, ketoconazole (sold as Nizoral, Extina, Xolegel, Kuric), VFend, etravirine (known as Intelence or TMC125), Felbatol, Prozac, Luvox, and Ticlid.

The manufacturers of Plavix have agreed to look at other possible drug interactions with Plavix. In the meantime, the Plavix label will be updated with new warnings on Prilosec and other drugs that could interact with Plavix in the same way. When more information becomes available, the FDA will communicate any additional recommendations or conclusions on the use of Plavix.

Finally, the FDA advised patients taking Plavix to consult their healthcare provider if they are currently taking or considering taking Prilosec, Prilosec OTC or Nexium. It is also very important that patients talk with their healthcare professional about any over-the-counter drugs they are taking before starting or while using Plavix. Patients should always consult with their healthcare professional before starting or stopping any medication.

Long-Term Use of PPIs May Lead to Dependency

Tue, 07 Jul 2009 00:00:00 -0400

Prilosec, Prevacid, Nexium, Protonix and other stomach acid reducers that belong to a class of drugs known as Proton Pump Inhibitors (PPIs) could lead to dependency if taken at prescription strength over an extended period of time, new research suggests. According to a report on Medicinenet.com, researchers at Copenhagen University have found that healthy adults without symptoms of acid reflux who took PPIs developed symptoms of the disorder when they stopped taking them after 8 weeks.

The study, which was published in the journal Gastroenterology, involved 120 healthy adults. According to Medicinenet.com, half of the subjects took 40 milligram doses of Nexium for 8 weeks, and a placebo for the final four weeks of the trial. The other half took a placebo for the entire 12 weeks.

At the beginning of the trial, participants in both groups reported similar gastrointestinal symptoms. But in weeks 9 through 12, 44% of those who had been taking Nexium reported increased symptoms, while in the placebo-only group, only 15% reported increased symptoms. By the end of the 12 week trial, despite being off Nexium for four weeks, 22% of those in that group still reported symptoms, while less than 2% in the placebo only group were reporting similar symptoms.

According to the researchers, all study participants did report that symptoms had stopped three months after Nexium treatment had ended.

According to Medicinenet.com, the researchers theorized that this "rebound" effect was likely a response to the acid suppression caused by Nexium that resulted in an overproduction of the stomach acid-stimulating hormone gastrin. The effect likely lasts between four weeks and three months, they said.

Despite this effect, the researchers said that the benefits of PPIs outweigh the risks for those who need them. However, according to Medicinenet.com, they expressed concern that the drugs are being overprescribed, and said doctors need to be more selective about how PPIs are prescribed.

PPIs are taken by millions of people - according to Medicinenet.com, it is estimated that 5% of adults in developed countries take the acid-reducing drugs. But PPIs have been the subject of safety concerns. As we've reported previously, a recent Canadian study of PPIs and osteoporosis-related fractures revealed a link between long-term PPI use and increased risk for hip, wrist, or spine fractures. We also reported in May that Plavix users were warned by the Society for Cardiovascular Angiography and Interventions (SCAI) to avoid PPIs following stent implantation because the combination increases the risks for heart attack (by 70 percent), stroke (48 percent), and other cardiovascular problems (repeat heart procedures by 35 percent). And most recently, we reported on a Canadian study that found a connection between routine prescription of PPIs during hospitalizations and an increased risk—30 percent—of acquiring pneumonia.

Plavix Users Should Avoid Heartburn Drugs

Thu, 07 May 2009 00:00:00 -0400

Plavix (clopidogrel) users are being warned by a group of heart experts to avoid some common heartburn drugs. HealthDay News is saying that patients taking the clot-preventing Plavix following stent implantation should stay away from PPIs, or proton pump inhibitors. Stents are implanted in artery-opening cardiac surgeries and PPIs, said HealthDay News, include drugs such as Nexium, Prevacid, and Prilosec.

According to the experts at the Society for Cardiovascular Angiography and Interventions (SCAI), the PPI-Plavix combination increases a patient’s risk for heart attack, stroke, and other cardiovascular problems, reported HealthDay News. The SCAI cited one study in which the PPI-Plavix combination was linked to significant increases: 70 percent for heart attack, 48 percent for stroke, and 35 percent for repeat heart procedures, said HealthDay News.

The SCAI said in a statement released at its annual meeting, "given the thousands of patients who receive stents each year, coupled with significant risks demonstrated in this study, SCAI recommends the use of alternative medications for gastrointestinal symptoms in patients with stents when appropriate," quoted HealthDay News. The group noted that additional research is called for and also pointed out that this recommendation refers to the older PPIs—Protonix, Nexium, Prilosec, and Prevacid—not the newer PPIs—Aciphex and Kapidex, said HealthDay News.

Data on nearly 17,000 Plavix users—who took the drug for over one year following stent implantation—were analyzed, said HealthDay News, citing Eric J. Stanek, senior director of research at drug distributor Medco Health Solutions. The team found that the incidence of cardiovascular events was 51 percent greater in patients taking the Plavix-PPI combination over those on Plavix alone, said Stanek, according to HealthDay News. "Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment," Stanek said.

PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. Since Plavix and PPIs are metabolized by the same liver enzyme, a PPI can reduce Plavix’s benefits, explained HealthDay News. Also, early studies linked the PPI-Plavix combination to increased cardiac risk and the U.S. Food and Drug Administration (FDA) issued an alert on this recently, said HealthDay News.

In past reports, we have discussed PPIs such as Prilosec and Nexium and that the FDA had investigated a suspected link between cardiac trouble and PPIs. Also, because such drugs may be overly effective at stopping stomach acid production, they have also been know to raise pneumonia, bone loss, and fracture risk; this, by over 40 percent in patients on long-term use.

A Canadian study of PPIs such as Aciphex, Nexium, Prevacid, Prilosec, and Protonix and osteoporosis-related fractures revealed a link between long-term PPI use and the increased risk for such fractures of the hip, wrist, or spine. It remains unclear how PPIs might increase fracture risk, but some experts believe it may be related to the medications’ stomach acid inhibiting qualities.

Plavix, Heart Burn Drug Combo Risky for Stent Patients, Study Says

Wed, 12 Nov 2008 00:00:00 -0500

Taking Plavix along with certain heartburn medications could be dangerous to stent patients. According to a recent analysis of a database kept by pharmacy benefits manager Medco Health Solutions Inc, the combination of Plavix and proton pump inhibitors, such as Nexium, places these patients at a greater risk of heart attack, stroke and other dangerous health problems than those who took Plavix alone.

Plavix is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. The medication keeps the platelets in the blood from coagulating to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Proton pump inhibitors are used to treat chronic heartburn. In addition to Nexium, other prescription proton pump inhibitors include Protonix and Prevacid.

The Medco study followed more than 16,000 patients in the database from 2005 to 2006. Of the patients inthe study, 9,862 patients were taking Plavix alone;and 6,828 patients were taking Plavix and a proton pump inhibitor.

All patients in the study had been implanted with a wire-mesh tube - a stent - to prop open arteries after they have been cleared of plaque. The study tracked whether they had been hospitalized for heart and circulatory problems within a year of the stent being implanted.

Of those who had not had a previous heart attack, only 21.2 percent of patients experienced a serious event within a year of their stent surgery. That number rose to 32.5 percent among those who took Plavix and a proton pump inhibitor.

Of those who did have a previous heart attack, 39.2 percent were hospitalized for a serious heart or circulatory event. For those taking only Plavix, only 26.2 percent did.

The database did not include patients who took over-the-counter proton pump inhibitors. Medco's chief medical officer and lead researcher on the study, Robert Epstein, told the Associated Press that the percentage of those who experienced a serious event would likely be even higher if such drugs were included in the study.

"Considering the widespread use of these two medications, this important research adds to a growing body of evidence raising questions about their concurrent use and suggests further research is needed," Epstein said in press release announcing the study's findings.

According to The Wall Street Journal, a study published in the journal Circulation in 2003 showed that nearly 30 percent of Plavix patients don't process the drug effectively. The Medco study could be an important clue as to why. People on Plavix are often prescribed proton pump inhibitors because Plavix has been linked to a higher risk of ulcers.

For Plavix to work, it must first be converted to its active form by a liver enzyme. The Medco researchers said proton pump inhibitors According to the Medco researchers, these drugs interfere with the liver enzyme, thereby reducing the amount of Plavix that is converted to an active form.

Acid Reflux Drugs Linked to Increased Fracture Risk

Tue, 12 Aug 2008 00:00:00 -0400

We have been reporting on drugs such as Prilosec and Nexium—part of a class of drugs called Proton Pump Inhibitors, or PPIs—that the US Food and Drug Administration (FDA) investigated for a suspected link between cardiac trouble and PPIs. Also, because such drugs may be overly effective at stopping stomach acid production, they have been know to raise pneumonia, bone loss, and fracture risk; this, by over 40 percent in patients on long-term use.

Now, a new Canadian study of PPIs such as Aciphex, Nexium, Prevacid, Prilosec, and Protonix and osteoporosis-related fractures has revealed a link between long-term use of PPis and increased risk for such fractures of the hip, wrist, or spine. The link appeared in patients taking PPIs after about seven years. PPI drug makers claim they haven't seen increased osteoporosis-related fracture risk in people using their products.

The study included about 63,000 adults aged 50 and older in Manitoba, Canada, and also included about 15,300 patients who sustained an osteoporosis-related fracture of the hip, spine, or wrist from 1996 to 2004. The researchers, including University of Manitoba's Laura Targownik, MD, MSHS, also reviewed participants' prescription records and found that those who received an osteoporosis-related fracture were nearly twice as likely to have taken a PPI for at least seven years; those on PPIs for six or less were not linked to fracture risk. Those with hip fractures were 62% more likely to have used a PPI for at least five years.

It remains unclear how PPIs might increase fracture risk, but some experts believe it may be related to their stomach acid inhibiting qualities. Targownik's team speculates that PPIs speed up bone mineral loss; however, the study doesn't prove this. Also, the researchers considered a variety of other factors, including participants' other prescriptions, medical history, and income.

Meanwhile, long-term PPI use and fracture risk have been linked in previous research and that association "is certainly a strong basis for encouraging further investigation," write the editorialists, who included J. Brent Richards, MD, of Canada's McGill University. "Certainly, at one extreme, such as in patients with bleeding ulcers, the beneficial effects may far outweigh the risks associated with fractures," the editorial states. "At the other extreme, liberal prescription of proton pump inhibitors for nebulous disorders for extended periods of time is likely worth revisiting."

Targownik's study doesn't specify which PPIs the patients took. AstraZeneca, maker of Nexium responded, "AstraZeneca does not agree with the conclusion of the CMAJ study," said spokeswoman Corey Windett Judee Shuler, senior director of corporate communications for Eisai Inc., maker of Aciphex, said the results "warrant further study, as these fractures are important medical issues that can occur for a variety of reasons.

According to an editorial published along with the study and that appeared in the Canadian Medical Association's journal, CMAJ , additional research is needed. Until then, they suggest patients and their doctors reevaluate the risks and benefits of long-term PPI use.

Prilosec, Nexium, Other Heartburn Drugs to Undergo Safety Review Following Hip Fracture Reports

Tue, 11 Dec 2007 00:00:00 -0500

Prilosec, Nexium and other proton pump inhibitors could increase the risk of patients’ suffering hip fractures, prompting the Food & Drug Administration (FDA) to initiate a safety review of the popular heartburn medications. At the same time, the FDA said that a just concluded review of Prilosec and Nexium did not find that the drugs put people at a higher risk of heart problems.

Prilosec and Nexium belong to a class of drugs called proton pump inhibitors. These medications provide a pronounced and long-lasting reduction of gastric acid production that relieves symptoms of severe heartburn, GERD, ulcers and other stomach ailments. In addition to AstraZeneca’s Nexium and Prilosec, other proton pump inhibitors include Wyeth's Protonix and Eisai Inc's Aciphex. Nexium, with sales of more than $5 billion last year, is AstraZeneca’s best selling medication, and was the world’s second best selling drug in 2006. Prilosec and Nexium are sold as prescription medications by AstraZeneca, while an over-the-counter version of Prilosec is sold by Proctor & Gamble.

In 2006, a British study found that taking Nexium, Prilosec and other proton pump inhibitors for a year or more raised the risk of a broken hip significantly in people over 50. The study, published in the December 2006 “Journal of the American Medical Association”, looked at medical records of more than 145,000 patients in England, where the average age of the patients was 77. The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk. The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.

At a briefing of reporters yesterday, the FDA said that it would begin a safety review of proton pump inhibitors to assess the hip fracture risk associated with these drugs. "Internally we've looked at the issue and we've asked the sponsors to send additional information and analysis," Joyce Orrick, deputy director in the gastroenterology unit at the FDA said during the briefing.

At the same briefing, the FDA said that a separate safety review of Nexium and Prilosec had not found that the medications increased patients’ risk of heart problems. The heart issue had been raised earlier this year after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from a common surgery to remedy severe reflux disease. After reviewing that research, the FDA discovered more patients getting the drugs already had a history of heart attacks, skewing the results of both studies. The FDA also said that it looked at 14 studies of Prilosec, the older of the two drugs, and was not able to conclude that there was an increased heart attack risk with the drug.

Heartburn Drugs = Broken Bones?

Fri, 29 Dec 2006 00:00:00 -0500

A new study reports elderly people taking prescription antacids could be at a greater risk of breaking a hip in a fall.
Tess Calbach goes to the Eau Claire Senior Citizen Center everyday and says she’s glad to have a place to “hang out.”
Several years back she had work done on her left hip.

She says her hip is doing fine now but she's taking medications for her stomach--Prilosec to be specific--a prescribed antacid.

She's been taking a pill a day with dinner for the past six years.

We asked her if she thought her bone replacements were because of the Prilosec. She says she doesn’t believe it had anything to do with it.

A study of nearly 14,000 hip fracture cases in Britain reports elderly people like Tess who take drugs like Prilosec, Prevacid, or Nexium may make it difficult for the body to absorb calcium.

That could lead to greater risks of getting broken hips.

“The longer you are taking this medication they found out that they risk of fractures actually goes up almost exponentially,” said Gastroenterology Dr. Olufemi Abiodun at Marshfield Clinic.

To be precise, the researchers report a 44 percent increased risk of breaking a hip during a fall.

But Dr. James O'Conner at Luther Midelfort doesn't agree it's that high.

“I think the direction is real there's probably a higher risk in that subgroup because the medications they reduce acidity.
Not all antacids are bad, O'Conner recommends Tums.

Tums have a calcium source so he even recommends taking five a day because people don't get enough of it in their diet.
Others like Zantac and Malox though are something different.

“The other drugs reduce the acidity in
the stomach and by reducing that, it reduces the ability for your body to metabolize and absorb calcium,” said O’Connor.
Doctors say more evidence is needed to prove the connections.

In the mean time, Tess says she's going to keep taking her meds.

“As long as I'm taking my vitamins and eat regularly I think my stomach can take care of it.

Antacids Like Prevacid, Nexium, and Protonix May Lead to Hip Fractures in Seniors

Wed, 27 Dec 2006 00:00:00 -0500

In light of a new study published this week, older people may be more willing to live with a little bit of heartburn. Today’s issue of the Journal of the American Medical Assoctiation (JAMA) reports that seniors who chronically take antacids may be more susceptible to potentially dangerous hip fractures. The key finding: Anti-heartburn medication, known as proton pump inhibitors (PPIs), may work to reduce the body’s absorption of calcium, which in turn can lead to a loss of bone density. Popular PPIs include Prevacid, Nexium, Aciphex, and Protonix.

In the JAMA report, researchers led by the University of Pennsylvania’s Dr. Yu-Xiao Yang noted, “We found a significantly increased risk of hip fracture associated with long-term PPI therapy, particularly among long-term users of high-dose PPI…. Calcium malabsorption secondary to acid suppressive therapy may potentially explain the positive association. Calcium solubility has been believed to be important for its absorption. An acidic environment in the gastrointestinal tract facilitates the release of ionized calcium from insoluble calcium salts.” The team also said that “the increase in fracture risk surged from a modest level with regular-dose PPI therapy to a much higher magnitude with high-dose PPI therapy.”

The study used the United Kingdom’s General Practice Research Database (1987-2003) to examine the medical records of nearly 150,000 British patients and included 13,556 hip fracture cases and 135,386 controls. The study cohort consisted of users of PPI therapy and nonusers of acid suppression drugs who were older than 50 years. The risk of hip fracture associated with more than one year of PPI therapy was 44 percent higher. However, among those patients prescribed long-term high-dose PPIs, the risk of hip fracture was significantly more than double. The longer the duration of PPI therapy, the stronger the association between PPIs and hip fractures.

A hip fracture in seniors can have potentially devastating consequences. The mortality rate during the first year after a hip fracture is approximately 20 percent. Another 20 percent will require nursing home care. Therefore, any reduction in the incidence of hip fractures would have far-ranging financial and medical implications. The authors are urging medical professionals to be more diligent when recommending PPI therapy, even with over-the-counter medications, and to make sure they’ve explained the potential risks to patients.

Study links heartburn drugs, broken hip

Wed, 27 Dec 2006 00:00:00 -0500

Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.

The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.

The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.

Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

"The general perception is they are relatively harmless," Yang said. "They often are used without a clear or justified indication for the treatment."

Some people find relief from heartburn with over-the-counter antacids such as Tums, Rolaids and Maalox. But for others, those medicines do not work well. Moreover, heartburn can be more than a source of discomfort. People with chronic heartburn can develop painful ulcers in the esophagus, and in rare cases, some can end up with damage that can lead to esophageal cancer.

Dr. Sandra Dial of McGill University in Montreal, who was not involved in the study but has done similar research, said patients should discuss the risks and benefits with their doctors and taper off their use of these medicines if they can.

Nexium, Prevacid and Prilosec are members of a class of drugs known as proton pump inhibitors. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid.

The study, published in Wednesday's Journal of the American Medical Association, looked at medical records of more than 145,000 patients in England, where a large electronic database of records is available for research. The average age of the patients was 77.

The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk.

The biggest risk was seen in people who took high doses of the drugs for more than a year. That group had a 2 1/2 times greater risk of hip fractures than nonusers.

Yang said that for every 1,262 elderly patients treated with the drugs for more than a year, there would be one additional hip fracture a year attributable to the drugs. For every 336 elderly patients treated for more than a year with high doses, there would be one extra hip fracture a year attributable to the drugs.

Dr. Doug Levine of AstraZeneca PLC, which makes Nexium and Prilosec, said the study does not prove that proton pump inhibitors cause hip fractures. It merely suggests a potential association, he said. Doctors need to monitor their patients for proper dosage and watch how long they take the drugs, Levine said.

Julia Ellwanger, a spokeswoman for TAP Pharmaceutical Products Inc., which markets Prevacid, said proton pump inhibitors' safety has been well-established by rigorous studies, and the new study does not prove or disprove a connection to hip fractures.

Dr. Alan Buchman of Northwestern University, who was not involved in the research, said the study should not change medical practice, since doctors already should be monitoring the bone density of elderly people taking the drugs and recommending calcium-rich diets to all patients.

"Most people are not taking enough calcium to start with," he said. He also wondered if a similar result would have been found in a sunny climate, because vitamin D from sunshine helps with calcium absorption.

Also, Buchman said it not known whether the acid-fighting drugs prevent esophageal cancer. He said the risk of esophageal cancer has been exaggerated in the marketing of these drugs.

"I think the risk has been overplayed and scared the community," Buchman said.

Heartburn medicines are heavily are advertised in "Ask your doctor about" commercials in this country, particularly during the evening news.

Nexium is the third biggest selling drug in the world, behind the cholesterol medicine Lipitor and blood thinner Plavix, with global sales totaling $5.7 billion last year, according to IMS Health, which tracks drug sales.

Yang and his co-authors disclosed in the paper that they have worked as consultants and received speaking fees from companies making acid-fighting drugs. The study was funded by the National Institutes of Health and the American Gastroenterological Association/GlaxoSmithKline Glaxo Institute for Digestive Health.

Men in the study had a higher drug-associated risk of hip fracture than women, possibly because women may be more aware of osteoporosis and may get more calcium in their diets, Yang said. He plans more research on whether calcium-rich diets or calcium supplements can prevent the problem.

Popular Heartburn Drugs May Lead to a Broken Hip

Wed, 27 Dec 2006 00:00:00 -0500

Heartburn relief may come with a hitch. Proton pump inhibitors, the class of drugs that includes Nexium, Prilosec, Protonix, Aciphex, and Prevacid, may increase the risk of a hip fracture for those over 50.

Research published in the new issue of the Journal of the American Medical Association found that people who took such prescription antacids for more than one year were 44 percent more likely to have a hip fracture than those who didn't take them.

"We think that calcium may be the major underlying mechanism here," says Yu-Xiao Yang, lead researcher and assistant professor of medicine and epidemiology at the University of Pennsylvania. PPIs reduce acid production in the stomach, and because acid helps absorb calcium, Yang speculates that the drugs may hinder the body's ability to absorb the bone-strengthening element.

Hip fractures are particularly devastating in older people, with an estimated mortality rate of 20 percent in the first year after a hip fracture. For those who survive, 1 in 5 needs nursing-home care, the researchers report.

Yang and colleagues analyzed people 50 and older in the General Practice Research Database from 1987 to 2003, a comprehensive pool of health data from patients in the United Kingdom. They assessed information on 13,556 hip fracture patients and 135,386 healthy patients, and they found that prescription PPI use was associated with greater odds of a hip fracture.

Longer-term use at higher doses made the problem worse. "There is a surge of risk when you go from a regular dose to a high dose," says Yang. The study found that people who used PPIs for more than a year at doses above the recommended prescription strength were nearly three times as likely to have a hip fracture as nonusers.

The research also found that male long-term users of the drug were slightly more prone to fracture their hips than female long-term users. Though use of calcium supplements wasn't measured, Yang suggests they might contribute to the gender disparity, since women over 50 commonly take calcium tablets. Yang says he has been recommending that patients on PPIs protect bone mass by boosting their calcium intake. "If you're taking PPIs, you don't want to be one of those people not getting enough calcium."

Michael Schaefer, chair of the department of orthopedic surgery at Northwestern University Feinberg School of Medicine, says the study sheds new light on the complex problem of osteoporosis, the reduction of bone mass that can lead to hip fractures. "Osteoporotic hip fractures are multifactorial," he says. While he's not convinced this new research solves the problem, he adds that "as an orthopedist, here is something I need to be aware of."

Schaefer tells his patients to quit smoking and increase physical activity–especially weight-bearing exercises–to combat and prevent osteoporosis. But he says he'll now urge patients on PPIs to take extra calcium. "I'm a big believer in calcium supplementation."

Prilosec Side Effects Lawsuits | Side Effects: Proton Pump Inhibitor Fractures, Bone Fractures, Bone Breaks, Hip Fractures, Wrist Fractures, Spine Fractures

Wed, 27 Dec 2006 00:00:00 -0500

Prilosec Side Effects Hip, Wrist or Spine Fractures Lawsuits

Prilosec | Lawsuits, Lawyers | Side Effects: Fractures, Bone Fractures, Bone Breaks, Hip Fractures, Wrist Fractures, Spine Fractures

Our proton pump inhibitor lawyers are investigating injuries linked to these heartburn treatments. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. Over-the-counter brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR. Proton pump inhibitors are extremely popular, with doctors writing roughly 113.4 million prescriptions for the drugs every year.

Prescription proton pump inhibitors like Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC and Prevacid 24HR are approved for the treatment of frequent heartburn.

In recent years, proton pump inhibitors have been linked to a number of serious side effects, including:

Increased risk of a hip, wrist or spine fractures
Interference with the blood-clotting properties of Plavix
Increased risk of serious cardiac event following a heart attack

If you or a loved one suffered one of these proton pump inhibitor side effects, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. Our proton pump inhibitor lawyers are currently offering free case evaluations to victims of these injuries. We urge you to contact us today to protect your legal rights.

Proton Pump Inhibitors and Fractures

Proton pump inhibitors work by reducing acid in the stomach. Over time, this may inhibit the body's ability to absorb calcium, which can lead to osteoporosis. In May 2010, the US Food & Drug Administration (FDA) announced that the safety labeling for both prescription and over-the-counter proton pump inhibitors would be updated to include information on an increased risk of certain fractures associated with their use.

The label change was based on the agency's review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group.

The FDA advised that healthcare professionals and users of proton pump inhibitors be aware of the possible increased risk of fractures of the hip, wrist, and spine, and weigh the known benefits against the potential risks when deciding to use these drugs.

Proton Pump Inhibitors and Plavix

In November 2009, the FDA issued a public health alert to warn Plavix users that Nexium and Prilosec could reduce that drug's anti-clotting effects. Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. As a result, patients taking both drugs could face a higher risk of heart attack or stroke.

The FDA issued the health alert after studies compared the amount of Plavix's active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.

Nexium also inhibits CYP2C19 and should also be avoided in combination with Plavix. The FDA advised people taking Plavix to consult their healthcare provider if they were currently taking or were considering taking Prilosec, Prilosec OTC or Nexium.

Proton pump inhibitors are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of CYP2C19 inhibition among other proton pump inhibitors varies, so it is unknown to what extent other proton pump inhibitors may interfere with Plavix.

Proton Pump Inhibitors After a Heart Attack

In September 2010, a study published of over 56,000 Danish patients discharged after a heart attack found that those who had at least one prescription for a proton pump inhibitor had a 29 percent increased risk of cardiovascular death or re-hospitalization for a heart attack or stroke in the 30 days after discharge compared with those who did not receive such a drug. The study was published in the Annals of Internal Medicine.

The study also cast doubt on concerns that proton pump inhibitors inhibit the effectiveness of Plavix. Among the patients in this study, the risk for additional cardiac events was exactly the same for those prescribed a proton pump inhibitor and Plavix, compared to those not prescribed a proton pump inhibitor. The researchers concluded that the increased risk of a heart attack, stroke or death is associated with proton pump inhibitors, and not the combination of Plavix and a proton pump inhibitor.

Legal Help for Victims of Proton Pump Inhibitor Side Effects

If you or a loved one were treated with proton pump inhibitors and suffered any of the above injuries, you may have valuable legal rights. Please fill out our online form, or call 1 800 LAW INFO (1-800-529-4636) to discuss your case with one of our proton pump inhibitor lawyers today.

Prilosec Linked to Hip Fractures

Prilosec (generic: omeprazole) is just one of a few antacid medications that are called proton pump inhibitors. Other common proton pump inhibitor drugs include Aciphex, Nexium, Prevacid and Protonix. Prilosec gained FDA approval in 2003 and is manufactured by Astra Zeneca.
Proton Pump Inhibitors Linked to Hip Fractures

On December 26, 2006, a report was released that showed the correlation between people taking powerful antacid drugs called proton pump inhibitors and the increased risk of hip fractures. The report was based on a University of Pennsylvania study that showed a class of antacid drugs called proton pump inhibitors could increase the risk of hip fractures as much as 260 percent. Proton pump inhibitors are usually prescribed for gastroesophageal reflux disease (GERD), and are.among the most widely used drugs in the United States. Popular drugs in the class include: Aciphex, Nexium, Prevacid, Prilosec and Protonix. which are often prescribed for stomach conditions such as

The University of Pennslyvania report can be found in the Dec. 27, 2006 issue of the Journal of the American Medical Association (JAMA).

"If you take acid-suppression medications on a chronic basis and you are 50 or older, your hip fracture risk is even higher than usual," said study author Dr.Yu-Xiao Yang, an assistant professor of medicine and epidemiology. "In addition, if you are one of the few patients who requires high doses, then your risk is even higher," Yang added.

Study Results

In the study, a team lead by study author Dr.Yu-Xiao Yang collected statistics on 13,556 people with hip fractures and 135,386 healthy people, all aged 50 or older. The researchers discovered that taking a proton pump inhibitor for more than one year increased the threat of hip fracture by 44%, compared with people not taking these medications. Additionally, the risk was 2.6 times higher among people who took high doses over a long period. The risk of hip fracture increased with both the dosage and the duration of proton pump inhibitor therapy, Yang's team found.

Yang said he feels these drugs are prescribed too often. "Not everybody is on this medicine for good reasons," he said. "Proton pump inhibitors have been on the market for 15 years, and the general feeling is that they are safe to be taken on a chronic basis. So, they are given often without having a clear indication or without making sure the patient is benefiting from the medication." Moreover, Yang thinks that both men and women taking prescription proton pump inhibitors should also take a calcium supplement to insure that they maintain their bone mass and lower their risk of hip fracture.

Dr. Lawrence Brandt, chief of the Division of Gastroenterology at Montefiore Medical Center, in New York City, said "Proton pump inhibitors are probably one of the most abused classes of drugs in the world. So, there are a lot of people on this medication who shouldn't be on this medication." While Acphex, Nexium Prevacid and Protonix all require a prescription, Prilosec is now sold over the counter which increases the potential for overuse.

Proton Pump Inhibitors and Hypomagnesemia

The long-term use of proton pump inhibitors has been associated with hypomagnesemia, a condition caused by low levels of magnesium in the blood. In March 2011, the U.S. Food & Drug Administration (FDA) mandated that the makers of prescription proton pump inhibitors include information about the potential risk of low magnesium in the WARNINGS AND PRECAUTIONS sections of the labels for all prescription proton pump inhibitors. Proton pump inhibitors subjected to the new warnings included: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, AcipHex, and Vimovo.

Low serum magnesium levels can result in serious adverse events including:

Muscle spasm
Arrhythmias (irregular heartbeat)
Seizures

According to the FDA, hypomagnesemia has been reported in adult patients taking proton pump inhibitors for at least three months, but most cases occurred after a year of treatment. Approximately one-quarter of these cases required discontinuation of proton pump inhibitor treatment in addition to magnesium supplementation. It is not understood why long-term proton pump inhibitor treatment sometimes results in hypomagnesemia. The FDA has recommended that healthcare providers consider obtaining serum magnesium levels before their patients begin treatment with prescription proto pump inhibitors. The agency said they should also consider periodic testing if patients are also being treated with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. In digoxin patients especially, low magnesium can increase the likelihood of serious side effects.

Legal help for Proton Pump Inhibitor Victims

If you or a loved one suffered a fractured hip as a result of using Prilosec, contact Parker & Waichman, LLP for a free case evaluation. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form to the right of this page.