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

Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit.

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Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008.

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The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff.

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The U.S. Food and Drug Administration is cracking down on manufacturers of alcoholic energy drinks, giving them 30 days to provide scientific evidence that their caffeinated crossover beverages are safe. FDA letters went out to nearly 30 manufacturers recently, representing the earliest stages in the government’s efforts to curb what researchers consider a dangerous trend: the mixing of alcohol and caffeine.

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“We are now in a position never before experienced in the history of influenza,” said Dr. Margaret Hamburg, Commissioner of Food and Drugs, in a letter to health care providers about the safety and availability of the 2009 H1N1 influenza vaccine. Just as a new and serious virus is spreading widely around the country, causing hospitalizations and deaths, a vaccine is becoming available to help prevent infection and protect the public.”

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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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