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

The Food and Drug Administration (FDA) is warning health care professionals, hospital personnel and patients that counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States and labeled with the C.R. Bard/Davol brand name. Four products have been identified to date as not being Bard-manufactured products. These products are used to reinforce soft tissue where weakness exists in the repair of hernias and chest wall defects.

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Several food products on store shelves have misleading labels that violate federal law, and the Food and Drug Administration (FDA) is warning companies to change those labels within 15 days or the agency will pull those products from grocery store shelves. The FDA sent warning letters to 17 different food makers last week demanding swift compliance.

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The Food and Drug Administration (FDA) has issued a Class 1 recall on a machine used in research laboratories because it may break, causing the potential for serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms. A Class 1 recall is the most serious type of recall the FDA can issue and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

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The Food and Drug Administration (FDA) is warning health care professionals and patients about a potentially serious side effect on the heart from use of two antiviral medications when given together to treat HIV infection. The warning is based on preliminary data from a clinical trial that suggests that Invirase (saquinavir) in combination with Norvir (ritonavir) may cause prolongation of the QT and PR intervals on an electrocardiogram. This prolongation may lead to abnormal heart rhythms such as torsades de pointes and heart block. These conditions may cause lightheadedness, fainting, or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heat beat known as ventricular fibrillation.

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Exjade (deferasirox), a treatment for chronic iron overload due to blood transfusions for adults and children age 2 years and older, now has an Food and Drug Administration (FDA) black box warning alerting health care professionals and consumers of a risk of serious complications that may lead to death. A black box warning is the strongest form of warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. As a result of the FDA warning, new language was added to the drug’s Contraindications, Warnings and Precautions, and Drug Interactions sections of its packaging. The labeling states that the product may cause renal impairment, including failure; hepatic impairment, including failure; and gastrointestinal hemorrhage. The warning affects Exjade Tablets for Oral Suspension.

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A class of asthma drugs known as Long-Acting Beta Agonists (LABAs) should never be used alone, warns the Food and Drug Administration (FDA), and manufacturers of these drugs will now be required to include this warning in the labels of their drugs as well as steps on how to reduce overall use of the products. The warning is based on FDA analysis of clinical trials of LABAs that show the drugs are associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults, and death in some patients with asthma.

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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 is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri.

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Toyota has found itself in a rather sticky situation. With more than eight million cars and trucks worldwide falling under a massive recall due to sudden unintended acceleration, the Japanese carmaker is looking for some sort of solution to pacify a growing anxious consumer base. Last fall, it blamed floor mats for the problem. Last month, Toyota announced the problem also fell on the vehicles’ gas pedals.

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