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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. (more…)

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. (more…)

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.

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. (more…)

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. (more…)

Study Confirms Actos, Other Thiazolidinediones Increase Bladder Cancer Risk

A new study confirms that Actos and other thiazolidinediones drugs do, in fact, increase the risk for developing bladder cancer. The study appears online this month in the Journal of the National Cancer Institute.

Researchers from the Perelman School of Medicine at the University of Pennsylvania discovered that patients taking Actos and other thiazolidinedione (TZDs) drugs suffer a two-to-three-fold increased likelihood of developing bladder cancer when compared to people who took a sulfonylurea drug, said Science Daily. TZDs comprise some 20 percent of medications prescribed to diabetics in the United States; sulfonylurias are another popular diabetes drug class that include Glucotrol (glipizide). (more…)

Benefits of Epogen, Procrit and Aranesp Overstated, Patients Paid the Price

Patients may have paid with their lives over three anemia drugs—Epogen, Procrit, and Aranesp—whose benefits have been overstated. In fact, financial benefits appear to have been the motivation in ensuring these drugs were broadly delivered; aggressive lobbying further ensured those benefits.

The drugs are Erythropoiesis-Stimulating Agents (ESAs). Epoetin alfa is marketed as Procrit and Epogen, and Darbepoetin alfa is marketed as Aranesp. As NewsInferno explained, ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the body’s bone marrow to make more red blood cells. Epogen is prescribed to treat anemia in chronic kidney disease patients; Procrit is approved to also treat anemia in cancer patients receiving chemotherapy. (more…)

New Propecia Study Finds Side Effects Are Long Lasting

Some users of popular hair loss treatment, Propecia (finasteride), have long argued that the drug has left them with enduring, sometimes permanent, sexual side effects. Now, a new Propecia study reveals that the drug’s side effects are, indeed, long lasting. For instance, reports ABC News, Kevin Malley, who was nearly 30 when began to lose his hair, visited his doctor for hair loss treatment and was prescribed Propecia. “I looked young for my age, so I wanted to hold off my hair loss for a little bit,” Malley told ABC News. “I didn’t plan on taking Propecia for more than a year,” he added. Malley began taking Propecia in May 2011; by that October, he was fully impotent, lost his sex drive, his genitals shrank, and he lost his concentration, said ABC News. Malley’s physician advised him that the side effects would disappear if he stopped taking Propecia; however, the symptoms remained. “I kept expecting the side effects to go away, but they did not, they only got worse,” he said. The study, just published in the Journal of Sexual Medicine, states that, in some men, Propecia’s sexual side effects may last months, even years, after patients stop taking the drug, said ABC News. George Washington University interviewed 54 men who were under the age 40 and who reported suffering side effects for three months or more after taking Propecia; none reported experiencing sexual, medical, or psychiatric issues prior to taking Propecia, said ABC News. All of the participants reported side effects that included erectile dysfunction; reduced sexual drive; orgasm issues; shrinking and painful genitals; and neurological problems that included depression, anxiety, and mental “fogginess,” said ABC News. In most of the men—an overwhelming 96 percent—they experienced sexual problems for more than one year after they stopped Propecia. “Our findings make me suspicious that this drug may have done permanent damage to these men,” Dr. Michael Irwig, study author, told ABC News. And, most shockingly, Dr. Irwig pointed out, “The chances that they will improve? I think it’s lower and

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lower the longer they have these side effects.” Despite more than 400 reports over 13 years reported to the U.S. Food & Drug Administration (FDA)—which approved the drug in 1997—Merck, the maker of Propecia, continues to maintain that its drug is safe,

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said ABC News. Regardless, in 2011, the FDA required that the Propecia and Proscar labels be changed to warn that some patients reported erectile dysfunction that lasted in some patients even after they stopped taking the drug; this April the FDA updated the label to also include reports of libido and ejaculation and orgasm disorders. “Merck believes that Propecia (finasteride) has demonstrated safety and efficacy profiles and that the product labeling appropriately describes the benefits and risks of the drug to help inform prescribing,” the company wrote in the statement, said ABC News. The researchers point out that the doctors prescribing Propecia probably don’t know that its side effects may last for months and years, even permanently. “These things just get handed out left and right for any urinary symptoms,” Dr. Ryan Terlecki told ABC News. He is an assistant professor of urology at Wake Forest School of Medicine, who has prescribed Proscar for some patients with enlarged prostates. NewsInferno explained that Propecia is part of the drug class 5-alpha reductase inhibitors (5-ARIs), as are Merck’s Proscar and GlaxoSmithKline’s Avodart and Jalyn. The FDA indicates that nearly 5 million men were prescribed one of these drugs during 2002-2009. All of the drugs work by preventing the androgen testosterone conversion to DHT, a hormone critical to male sexual performance.

Oregon Woman Sues Over Injuries Allegedly Caused by Biomet Metal-On-Metal Hip Implant

An Oregon woman is suing over injuries she alleges were caused by a Biomet metal-on-metal hip implant. The lawsuit was filed on her behalf by the national law firm, Parker Waichman LLP and names Biomet Orthopedics, LLC, Biomet, Inc., and Biomet, LLC as defendants. The woman alleges that she suffered pain and had to undergo revision surgery to remove and replace her defective Biomet M2a Magnum hip implant.

The lawsuit—filed on July 2 in the U.S. District Court for the Northern District of California (Case No. 3:12-cv-3476)—alleges that the Biomet M2a Magnum Hip Implant System is defective and causes the implant to shed excessive amounts of cobalt and chromium, which may cause device rejection. (more…)

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