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Avoid Benzocaine for a Teething Baby, FDA Warns

Avoid benzocaine for teething babies, the U.S. Food & Drug Administration (FDA) warns. According to the agency, benzocaine products should only be used to relieve teething pain in babies under the advice and supervision of a physician.

A local anesthetic, benzocaine is a fairly ubiquitous ingredient found in a number of over-the-counter (OTC) products including, Anbesol, Orajel, Baby Orajel, Orabase, and Hurricane noted Medical Xpress. (more…)

CPSC Files Suit to Ban Buckyballs Magnetic Toys

A lawsuit has been filed by the U.S. Consumer Product Safety Commission (CPSC) to ban Buckyballs and Buckycube magnetic desk toys, the Commission announced. The CPSC filed an administrative

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complaint against Maxfield & Oberton Holdings LLC, of New York, New York, alleging that Buckyballs and Buckycubes contain a defect in design, packaging, warnings, and instructions, which pose a substantial risk of injury to the public. The Commission voted 3-1 to approve the filing, which seeks, in part, an order that the firm stop selling the toys, notify the public of the defect, and offer consumers a full refund. Manufactured by Maxfield & Oberton, the toys have been linked to significant and ongoing harm. (more…)

Wright Medical Tried to Block Approval of Rival’s Birmingham Metal-On-Metal Hip Implant

Device maker, Wright Medical, worked to block approval of its rival, Birmingham’s, metal-on-metal hip implant device from reaching United States implant patients, according to U.S. Food & Drug Administration (FDA) filings. At the same time that the agency was reviewing a pre-market approval (PMA) application for the Smith & Nephew’s device—the first metal-on-metal implant—Wright filed a citizen’s petition that claimed the study behind the PMA application was not sufficient to prove the device’s safety and efficacy, said MassDevice (more…)

Seizure Warning Issued for MS Drug

The U.S. Food & Drug Administration (FDA) just issued a seizure warning for multiple sclerosis (MS) drug, Ampyra (dalfampridine). Ampyra has been linked to increased seizure risks in MS patients.

Developed by Acorda Therapeutics, Ampyra is marketed by Biogen Idec Inc in Europe under the brand Fampyra, explained Reuters. The drug was created to improve walking ability in MS patients. Based on post-market adverse event reports it reviewed, said the agency, the seizure risk in MS patients—none of whom had a history of seizure—was evidenced within days and weeks after beginning treatment with the recommended dose, noted Reuters. (more…)

Rhode Island Woman Claims Fosamax Caused Painful Thigh Break

Merck is facing yet another Fosamax lawsuit. This time, the national law firm, Parker Waichman LLP, filed a lawsuit on behalf of a woman who took Fosamax (alendronate) and suffered a right femur fracture, allegedly due to the bone loss medication.

Prescribed to fight bone loss in patients with osteoporosis and other conditions, the bisphosphonate drug has been linked to increased risk of atypical femur fractures. The law suit names Merck Sharp & Dohme Corp. and Merck & Co. as defendants. (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…)

Indiana Woman Claims Fosamax Caused Two Femur Fractures

Yet another woman has come forward to say that Fosamax (alendronate) caused her two femur fractures. The national law firm, Parker Waichman LLP, just filed a lawsuit on behalf of an Indiana woman who suffered a left and right femur fracture after taking Fosamax.

Fosamax, an oral bisphosphonate, is in a class of drugs that the U.S. Food & Drug Administration (FDA) says may not provide any long-term benefits, while simultaneously increasing risks for atypical femur fractures. The lawsuit names Merck Sharp & Dohme Corp., Merck & Co., Inc, and other potential manufacturers as defendants and was filed on June 29th in the Superior Court of New Jersey, Atlantic County Law Division (Case No. L-4565-12). (more…)

Pradaxa Patients Await Word On MDL

Pradaxa patients, involved in about 12 dozen lawsuits in Illinois alone, are awaiting word on multidistrict litigation (MDL) concerning injuries they allege are linked to the controversial blood thinner.

The 12 Illinois lawsuits represent about half of what Boehringer Ingelheim Pharmaceuticals, Inc., and some other foreign corporations in the United States, face. Boehringer is the maker of Pradaxa. The cases have been filed since May of this year in the U.S. District Court for the Southern District of Illinois, said the Madison Record; plaintiffs are waiting to learn if an MDL will be created to handle the claims. Eight complaints were filed against Boehringer in May in the East St. Louis federal court; three were filed in June, and another was filed this month, the Madison Record explained. (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.

Stryker Hip Component Recall Undermines Defense in Metal-On-Metal Lawsuits

Stryker Corp.’s recent recall of hip device components is expected to undermine the device maker’s defense in metal-on-metal hip implant lawsuits. Stryker recently recalled its Rejuvenate Modular and ABG II modular-neck hip stems.

Some hip implant device makers can also expect to be hit hard by the news. At the center of a debacle involving the safety and longevity of metal-on-metal hip implant devices, many manufacturers maintain that their devices are safe, despite unprecedented early failure rates and patient surgeries to remove faulty devices. Sryker’s recall of two metal hip replacement components calls into question device makers’ arguments with similar injuries seen in these components and in implants involved in litigation. (more…)

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