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Pharmaceutical 5861 articles

Beasley Allen has one of the largest and most technologically advanced Mass Torts practices in the country. The Mass Torts division represents numerous people in claims against companies that manufacture and/or market defective pharmaceuticals and/or medical devices. The resources devoted to this division allow the firm to competently and conscientiously handle any group of cases, no matter how large, along with particular catastrophic injury cases.

Our firm was recently involved in one of the greatest victories in Mass Torts history, against drug manufacturer Merck regarding the drug Vioxx. After more than five years of hard-fought and difficult litigation, Merck agreed to pay $4.85 billion, the largest pharmaceutical settlement in U.S. history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack, including sudden cardiac death, or a stroke.

FDA warning letter: Pfizer’s generic of top-selling MS drug Copaxone likely to be delayed

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Food and Drug Administration (FDA) clearance of Pfizer Inc.’s generic version of the top-selling multiple sclerosis (MS) drug Copaxone is expected the first quarter of 2017, but an agency warning letter disclosed last week regarding a May 2016 inspection could delay that approval. Copaxone is manufactured by Teva Pharmaceutical Industries Ltd., and is one of the world’s best-selling drugs, generating sales of $3.5 billion last year in the U.S. alone. Pfizer’s generic, called Glatopa, is manufactured partnership with Sandoz Inc. and Momenta Pharmaceuticals Inc. Glatopa has been available in a 20-milligram version since 2015, but the 40-milligram version makes up about 84 percent ... Read More

Study: Testosterone treatment has no effect on memory, mental function in older men

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Testosterone replacement therapy is approved for the treatment of hypogonadism, a condition in which men do not produce enough of the male hormone due to disease, injury or defect. But manufacturers of testosterone treatments have heavily promoted the product to treat symptoms of so-called “Low T,” such as low libido, memory loss, weight gain, muscle loss and mood swings. The marketing strategy worked surprisingly well, resulting in skyrocketing sales of testosterone replacement therapies that eventually raised concerns that the drugs were being prescribed to men who actually didn’t need it, such as older men who naturally see a dip in ... Read More

Synergy Rx Pharmacy expands recall to include weight loss treatments, acne creams, chemical peels

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Synergy Rx Pharmacy has expanded a recall issued earlier this month on all lots of injectable Human Chorionic Gonadotropin (HCG), to include the following non-sterile products – Sublingual Tablets, HCG and HCG with resveratrol Human Chorionic Gonadoptropin), Non Sterile Dermatology creams all strengths (retinoic acid creams, hydroquinine creams, bleaching creams), Numbing Creams, acne creams, hair growth serums with minoxidil, betamethasone creams and Chemical Peels (salicylic acid peels, trichoracetic acid peels, glycolic acid peels, Jessners Peels, custom peels solutions). The recall was initiated due to lack of quality assurance. Administration of a drug product which does not meet the quality assurance ... Read More

Sexual enhancement dietary supplement recalled

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Organic Herbal Supply Inc., has issued a nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules after a Food and Drug Administration (FDA) analysis found that the dietary supplements contained a hidden drug ingredient, Tadalafil, the active ingredient in the prescription erectile dysfunction drug Cialis. This drug poses serious health risks to men who take nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The recall comes about two weeks after the FDA warned consumers not ... Read More

Plaintiffs Push to Consolidate Smith & Nephew Metal-on-Metal Hip claims in MDL

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On Feb. 1, plaintiffs filed a petition asking the Judicial Panel on Multidistrict Litigation (JPML) to consider consolidating complaints against Smith & Nephew over its Birmingham Hip Resurfacing (BHR) and R3 Acetabular System devices. As many as 31 cases are still pending in 22 federal district courts, according to the petition, and dozens more are expected to flood in. Pretrial coordination before a single judge in Maryland would facilitate resolution of the claims, the plaintiffs say. In June of 2012, Smith & Nephew recalled its R3 Acetabular System, an optional metal liner component used in hip implant devices. This includes about 7,700 metal liners that ... Read More

Psoriasis drug Humira linked to lupus erythematosus

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The plaque psoriasis drug Humira has been linked to drug-induced lupus erythematosus (DILE) in a case study published in the Journal of Clinical Pharmacy and Therapeutics. Humira, known chemically as adalimumab, is an immunosuppressant drug that is approved by the Food and Drug Administration (FDA) to treat arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. The case study, detailed by Iva Lomicová, M.D., from Charles University in Pilsen, Czech Republic, and colleagues, involves a patient with severe psoriasis who was treated with adalimumab, but discontinued the medication two weeks prior to having a hysterectomy. A month later, she ... Read More

Six things to know about dietary supplements

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Dietary supplements often promise to contain all-natural ingredients and to deliver too-good-to-be-true effects when it comes to weight loss, athletic performance, sexual enhancement, disease treatment and prevention, and more. But buyer beware, says Paul Doering, a professor of Pharmacy at the University of Florida’s College of Medicine. Nutritional supplements may not be all they’re cracked up to be and, in some cases, they may be dangerous. Doering offers six tips to consider before buying these over-the-counter and mail-order remedies. 1. Be suspicious when you see a “kitchen sink” worth of ingredients. Supplement companies will often add chemicals with lengthy names ... Read More

Clinical study supports effectiveness of non-drug treatment for infant acid reflux, Safe alternative to PPIs

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A new clinical study looks at the effectiveness of the Bare Air-Free feeding system as a non-drug treatment for infant acid reflux by tracking the changes in acid reflux (or GER) symptoms in 122 infants over a two-week period. The infants were divided into a control group with typical GI functioning and a GER group that had clinically significant ratings of GER symptoms based on the Infant- GER Questionnaire (I-GERQ). The researchers found that not only did the Bare Air-Free reduce clinical symptoms in the GER group, 75 percent of the babies in that group no longer met the clinical ... Read More

Dietary supplement maker sentenced, fined for selling illegal steroids

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Matthew Greaten, 50, former president and owner of Virginia-based Nature’s Chemistry LLC, was sentenced and fined by a federal judge in Virginia for selling dietary supplements that contained a dangerous and illegal hidden drug ingredient. Greacen and Nature’s Chemistry vice president James W. Mills were accused of manufacturing nearly 45,000 bottles of capsules containing methasterone, known by the name Superdrol, an anabolic steroid that was never marketed through legitimate channels for medicinal purposes. The U.S. Attorney’s office calls Superdrol a dangerous “designer steroid.” Anabolic steroids are used – and often misused and abused – by athletes and bodybuilders to build ... Read More

Scalp cooling devices good news for Taxotere users worried about risk of permanent hair loss?

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In an editorial accompanying two separate studies on scalp cooling devices, both published online Feb. 14 in JAMA Oncology, Dawn L. Hershman, MD, from the Herbert Irving Comprehensive Cancer Center at NewYork–Presbyterian/Columbia University Medical Center, New York City speaks about quality of life for individuals with cancer. The scalp cooling devices are designed to help to prevent chemotherapy-induced alopecia (hair loss) by reducing blood flow to the scalp and thus the amount of chemotherapy delivered to the hair follicles. She said that “[o]ne of the strongest deterrents for a woman who is deciding whether to undergo chemotherapy is concern about alopecia.” ... Read More