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Research Suggests Proton Pump Inhibitors Overused

New research suggests that Proton Pump Inhibitors (PPIs) such as Aciphex, Dexilant, Nexium, Prevacid, Prilosec, and Protonix are being overused. The information comes from series of studies reported at the American College of Gastroenterology’s recent, annual meeting. According to the studies, said WebMD, doctors are over-prescribing PPIs both in and out of hospital settings. “I’m uncomfortable when people who have heartburn start the drugs on their own, or when a health care professional guesses and puts them on the drugs,” says Mayo Clinic gastroenterologist Yvonne Romero, MD, reported WebMD. Romero was not involved in the research, but reviewed the findings for WebMD. One study found that most patients studied—60 percent—were prescribed a PPI while hospitalized and, typically, because they were prescribed a PPI prior to admission; 26 percent were inappropriately prescribed a PPI, said WebMD. Research found that 44 percent were sent home with a PPI prescription and 9 percent of these people had no obvious reason for staying on the PPI after discharge, said WebMD. A Canadian study revealed that 70 percent of patients studied were prescribed PPIs or H2RA drugs for ulcer prevention during intensive care stays but, in 97 percent of the cases, drug use was inappropriate, said WebMD; about 40 percent were released with an unnecessary prescription for the drugs with PPIs less likely to be discontinued versus H2RA drugs. “Prescription of a proton pump inhibitor in the ICU was associated with the inappropriate prescription of the proton pump inhibitor upon hospital discharge,” said study leader Jasjeet Rai, MD, of McGill University in Montreal, WebMD reported. Other studies revealed PPIs being taken without medical supervision and that drugs were taken for longer than needed or when not needed. PPIs are considered the strongest class of antacid medications and are the third-greatest selling class of drugs in the United States, said WebMD. Doctors wrote 113.6 million PPI prescriptions; however, some are available without a prescription, such as Prevacid 24HR, Prilosec OTC, and the combination medication Zegerid OTC that contains a PPI and sodium bicarbonate, WebMD explained. Popular because they effectively reduce stomach acids in ways that other, simpler OTC medications—Tums, Rolaids, Maalox—can not, they are also more powerful

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that H2 receptor antagonist (H2RA) drugs such as Axid, Pepcid, Tagamet, and Zantac, said WebMD, pointing out that popping a PPI is a lot easier than giving up favorite foods. Romero explained that “If you take them indiscriminately, you reduce the benefit-to-risk ratio.” Studies have linked PPIs to increased risks for Clostridium difficile (C. diff), a serious, sometimes deadly, diarrheal disorder, noted WebMD. NewsInferno just wrote about PPIs’ increased risks for fractures of the hip, spine, and wrist; increased risks for serious infections such as pneumonia and C. diff; and severe magnesium deficiency, which can cause life-threatening cardiac arrhythmias. Although these, and other serious side effects, are indicated on the drug’s labels, none have received the prominent and significant black box warning, which could be contributing to the fact that many physicians are unaware of the serious risks associated with PPI therapy. Most recently, consumer watchdog, Public Citizen, petitioned the U.S. Food & Drug Administration (FDA) to mandate manufacturers list serious adverse reactions associated with PPIs in a black box warning, said NewsInferno. Public Citizen wrote that evidence indicates that after using PPIs for a month or more, patients who stop will make even more stomach acid than before PPI treatment, so-called rebound acid hypersecretion, in which acid reflux symptoms return even worse than before therapy, explained NewsInferno. Patients begin taking PPIs again, leading to long-term dependency.


Parker Waichman Files Lawsuit on Behalf of DePuy Pinnacle Hip Implant Recipient

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of a New York man who allegedly suffered severe injuries after being implanted with a metal-on-metal Pinnacle Hip Implant device. The Pinnacle device, implanted for total hip replacement, is manufactured by DePuy Orthopaedics, a unit of Johnson & Johnson.

Both DePuy Orthopaedics, Inc. and Johnson & Johnson are named as defendants in the action that was filed on April 12, 2012, in U.S. District Court for the Northern District of Texas. Hundreds of other, similar, lawsuits are currently consolidated in the DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, MDL No. 2244 (Case No. 3:11-md-02244) in Texas. Continue »


Propecia Interferes With Male Hormones, Causes Sexual Dysfunction In Men

Popular hair thinning medication, Propecia, interferes with male hormones and causes male sexual dysfunction, according to new research. Propecia (finasteride) is manufactured by Merck & Co.

Although seen by many as a solution to what can be the devastating loss of hair in many, especially young men, noted the Brisbane Times, research has found that Propecia interferes with male hormones, such as testosterone derivatives. This interference has led to a host of adverse side effects that are both worrisome and long-lasting, even permanent. Continue »


Smith & Nephew Issues Safety Alert for Birmingham Hip Implant Components

Medical device maker, Smith & Nephew, just issued a safety alert for its components in its Birmingham hip implant line, following emergent data on the their failure rate.

The safety alert, does not, pointed out Becker’s Spine Review, include a device recall; however, the device’s failure rate does exceed the U.K.’s National Institute for Health and Clinical Excellence’s benchmark of one percent. Smith & Nephew’s Birmingham Hip Modular Head implants are part of a collection of the manufacturer’s devices that led the way for the metal-on-metal hip implant field in 1997.

In its notice, Smith & Nephew updated indications for its Birmingham Hip Modular Head implants following data from U.K. and Australian registries which revealed a 1.29 percent (U.K.) and 1.12 (Australian Orthopaedic Association’s National Joint Replacement Registry) percent failure rate, said Becker’s Spine Review. The updated indications restrict the device to its Synergy stems and during revision surgeries, in which cases the failure rate drops to 1.07 percent, which is considered acceptable, according to a report issued by MassDevice.com, said Becker’s Spine Review.

Smith & Nephew spokesman, Joe Metzger, told Mass.Device.com, “…we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision. The potential risks that may result from use of the device have not changed.”

“They may include pain and limited mobility, potentially leading to revision surgery. Females of child=bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery,” Metzger also noted. “This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure,” Metzger told MassDevice.com.

The alert, which did not go as far as to recall the device, is still a blow to industry, which has been mired in controversy, lawsuits, recalls, and growing injury reports and involves a number of device makers, including Johnson & Johnson’s DePuy Orthopaedics’ unit, Biomet, Zimmer, and Wright Medical.

NewsInferno explained that introduction of the Birmingham hip replacement line prompted other device makers to bring metal-on-metal hip devices to market. This summer, MassDevice.com reported that Smith & Nephew rival, Wright Medical Inc., challenged the company’s 2006 application for U.S. Food & Drug Administration (FDA) approval of the Birmingham. The claims included that the study used in Smith & Nephew’s application was insufficient in the areas of safety and efficacy. The FDA did grant two pre-market approvals for the Birmingham in May and October 2006; the latter approval involved additional sizes.

Metal-on-Metal hip implant devices have been blamed for shedding dangerous amounts of metal debris in patients, leading to premature implant failure, adverse local tissue reactions, metallosis, pseudotumor formation, and a host of other long-term health problems.


Arguments Heard in Proposed Biomet Metal-On-Metal Hip Implant MDL

Arguments are being heard in a proposed Biomet metal-on-metal hip implant multidistrict litigation (MDL). NewsInferno recently wrote that a lawsuit filed in a Nevada federal courtroom claimed the Biomet M2a-Magnum metal-on-metal hip system is both defective and has a high early failure rate; these issues led to serious and debilitating injuries from, yet another, patient implanted with these devices.

The question remains: Will the Biomet M2a-Magnum hip implant device lawsuits will be consolidated in one court? An answer is expected this week following a hearing before the U.S. Judicial Panel on Multidistrict Litigation (JPML) on September 20, 2012, said The Legal Examiner. To date, some 40 Biomet lawsuits have been filed in federal courts nationwide, with plaintiffs alleging that the device leads to metal poisoning—metallosis—and early loosening, which, in turn, necessitate complex and painful revision surgeries. Continue »


Metal-On-Metal Hip Implant Warning Issued in Australia

A metal-on-metal hip implant warning was just issued in Australia, adding to the controversy surrounding the medical devices.

The Australian Government’s Department of Health and Ageing’ Therapeutic Goods Administration (TGA) recommends that patients implanted with a metal-on-metal hip replacement device speak to their surgeons on an ongoing basis and receive regular ultrasound, MRI, and blood testing, said Top News. “There’s a growing body of evidence that when the ball and socket components wear against each other they can release trace amounts of chromium and cobalt,” said the TGA. Continue »


FDA Says Mirapex May Pose Risk of Heart Failure

The U.S. Food & Drug Administration (FDA) just announced that Parkinson’s disease medication, Mirapex (pramipexole), may pose increased risks for heart failure. The agency notified health care professionals following release of recent study results.

A Parkinson’s disease drug, Mirapex is also approved to treat the symptoms of moderate to severe primary restless legs syndrome. Mirapex is in the class of drugs called dopamine agonists and works by acting in place of dopamine. Dopamine is produced by specific areas of the brain that control movement; Parkinson’s disease causes progressive loss of dopamine production in the brain. Continue »


Metal-On-Metal Hip Implants Not Linked to Early Cancer Risk, Study Says

Metal-on-metal hip implant makers received a bit of a reprieve in the ongoing controversy surrounding their devices. An emerging announcement states that the often-defective implants are not linked to an early cancer risk.

The researchers stressed, however, that the results were limited and more study and observation are needed, said Mass Device. A Reuters report noted that the researchers were unable to reach a conclusion about cancer risks linked to metal-on-metal hip replacement over the long-term, noted NewsInferno. Continue »


Skechers Shape-Ups Toning Shoes Claims Questioned

Claims made by Skechers over the company’s Shape Up toning shoes are being questioned. Using celebrity endorsers, such as Kim Kardashian, Brooke Burke, and Joe Montana, Skechers Shape-Ups were heavily touted as a way in which to promote weight loss and muscle tone.

The trademark rounded Skechers’ Shape-Up sole promotes an unstable gait that can lead to injuries, including falls and fall-related injuries, which can allegedly cause hip fractures; rolled and twisted ankles; broken bones, stress fractures, and joint dislocation; and back strain. Continue »


Seven Sue Stryker Over Recalled Rejuvenate Hip Implant

Seven are suing device maker, Stryker, over its recalled Rejuvenate hip implant. Stryker recalled the Rejuvenate and AGB modular-neck hip stems and ceased global distribution of the products this July.

An additional seven plaintiffs have filed lawsuits in Superior Court in Hackensack, New Jersey, alleging that Stryker was negligent in selling them a defective hip replacement device, said NorthJersey.com. The seven additional plaintiffs are from Arizona, Florida, and Minnesota. Continue »


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