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Antibiotic contaminated with potentially dangerous bacteria

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Four lots of VistaPharm Inc.’s Nystatin Oral Suspension, an antibiotic used to treat fungal infections of the mouth including oral thrush, were found to be contaminated with the Burkholderia cepacia, a bacteria that can cause life threatening bloodstream infections, particularly in patients with weakened immune systems. B. cepacia infections can range from mild with no symptoms to severe with serious respiratory symptoms. It is especially dangerous to patients with cystic fibrosis. VistaPharm identified the source of the bacterial contamination as likely being purified water that was used to manufacture the drug products. Affected products include prescription only Nystatin Oral Suspension, ... Read More

Changes in epilepsy treatment may affect patients’ wellbeing

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Adjusting anti-seizure treatment for patients with epilepsy can negatively impact the patient’s emotional wellbeing, according to a study published in the journal Epilepsy and Behavior. The study was designed to help physicians better understand how changes with anti-epileptic drugs (AEDs) affect patients’ emotions. For the study, researchers asked members of an online epilepsy community to participate in a survey consisting of 31 questions. The 345 participants, all of whom had a diagnosis of epilepsy or seizure disorder, were asked to rate their feelings on a recent AED change. Researchers also collected comments from epilepsy-related online forums and social media websites ... Read More

AndroGel makers try to shake testosterone side effects lawsuits

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AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes. Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials. The motions for summary judgment were filed just months before the companies ... Read More

FDA warns Fresenius subsidiary over omitting risk information on blood bank product

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Fresenius Kabi AG’s subsidiary Fenwal Inc., was slapped with a Food and Drug Administration (FDA) warning letter for repeatedly omitting all risk information from a blood bank product. “Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials,” the letter states. The issue involves Fenwal’s distributed promotional material for InterSol, an isotonic solution. The information cautions against intravenous infuse, reuse of the product and use of cloudy ... Read More

More Information revealed following Mahoney’s Auto Mall hazardous waste Indictments

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Recently, Mahoney’s Auto Mall and employee Andrew Fuller in Potsdam, New York, were indicted for burying 55-gallon drums full of used oil, containers of used oil filters and tires, totaling 140 gallons of hazardous substances. The hazardous waste was discovered buried on the auto dealership’s property, which led to 12 counts of felony third-degree endangering public health, safety or the environment, and eight counts of misdemeanor fourth-degree endangering public health, safety or the environment. “Failing to properly dispose of hazardous material jeopardizes the health of New Yorkers and the surrounding environment,” Attorney General Eric T. Schneiderman said in his press release. “We will continue to hold ... Read More

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

At Least Two Motorists Injured After Tractor Trailer Spills Steel Beams on NJ Highway

truck crash New Jersey steel beam - image by NBC 10 News

Two tractor trailers set off a harrowing highway accident in Paramus, New Jersey, Wednesday, Feb. 22, seriously injuring a New York man whose passenger vehicle was struck by a steel beam that flew off one of the commercial trucks. Crash reports indicate the accident may have started with a mechanical problem or malfunction in one of the commercial trucks. Police investigating the crash reported that the 63-year-old driver of one of the tractor trailers said the brakes of his truck locked as he slowed for traffic in the northbound lane of Route 17 in Paramus. The truck became disabled and ... Read More

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

Low T

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