Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.

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Off-label marketing is an illegal yet commonly employed sales strategy that some big pharmaceutical companies practice to broaden the appeal of a drug and boost sales. One of the most blatant examples of off-label marketing involved Bayer Healthcare’s blockbuster birth control pill Yaz. Bayer promoted the drug as a treatment for premenstrual dysphoric disorder (PMDD) symptoms and to clear up moderate cases of acne when the FDA approved it as birth control only. Bayer stopped the deceptive marketing of Yaz when the FDA cited it for false and misleading advertising.

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The U.S. Food and Drug Administration warned consumers yesterday that the dietary supplement Stiff Nights contains sulfoaildenafil, a chemical compound similar to sildenafil, the active ingredient found in Viagra. When combined with prescription nitrates, including nitroglycerin, sildenafil can cause blood pressure to drop dangerously.

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Spurred by a request by the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral intravenous drug peramivir for use in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza (swine flu) who are admitted to the hospital.

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Despite the efforts of the federal government to keep America’s food supply clean, every year nearly 80 million people in the United States fall ill after eating food contaminated with dangerous bacteria such as salmonella, listeria, and E. coli. The Centers for Disease Control and Prevention estimates that approximately 5,000 Americans inflicted with food poisoning die every year.

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The U.S. Food and Drug Administration issued a public health alert Thursday after finding errors with the measurements on the dosing dispenser included in Tamiflu packaging. Tamiflu is the brand name of Oseltamivir, an antiviral prescription drug used to treat people infected with the influenza virus. Produced by Swiss global health care company F. Hoffman-La Roche Ltd., Tamiflu has been used extensively throughout the world during the last decade to help curb the spread of the flu virus within patients.

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The U.S. Food and Drug Administration announced another massive recall of fresh produce last week, this time for 1,715 cartons of bunched spinach that tested positive for salmonella bacteria in a random test conducted by the USDA. Alarmed by the frequency of foods recalled over bacterial contamination fears, many consumer advocacy groups and legislators have indicted the federal government’s food inspection system, calling for an overhaul of the FDA and USDA systems currently in place. But in an age of mass production and processing that makes cross contamination ever more likely, it’s wise for the consumer to take certain measures to mitigate the risk of becoming sick from tainted food.

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The Food and Drug Administration (FDA) has issued a Class 1 recall on a type of surgical drills, blades and bone and cutting devices because the tools can unintentionally self-activate and move in unintended directions. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that the use of the products will cause serious injury or death.

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The Food and Drug Administration (FDA) announced today that it has completed its analysis on a class of arthritis drugs known as tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with use of the drugs.

The analysis first came to light in early June through an early communication by the FDA, and early last month the FDA said it would require the drug makers to add a stronger warning to the black box warning currently on the products, which warns of an increased risk of malignancies but does not specifically mention leukemia. The new labeling will also add a warning of the occurrence of a new-onset psoriasis in patients treated with TNF blockers.

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With the nation’s healthcare system groaning under epic pressure, you would think that the pharmaceutical giants would be a little more judicious in the way they promote their drugs and sell them to federal, state, and municipal government programs. Perhaps they will be, now that the United States Department of Justice has slapped Pfizer with a record $2.3 billion fine for defrauding the Medicare and Medicaid programs.

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