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

Cleocin HCL (clindamycin hydrochloride) capsules, an antibiotic used to treat serious infections caused by bacteria, has received a new black box warning about the risk of Clostridium difficile (C. difficile) associated diarrhea (CDAD) that may range in severity from mild diarrhea to fatal colitis, according to the Food and Drug Administration (FDA). CDAD has been reported with use of nearly all antibacterial agents, including Cleocin HCL. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Clostridium difficile.

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Tekturna (aliskiren) tablets, a prescription medication used to treat high blood pressure, has updated its safety label to include a new black box warning about the risk of injury and death to developing fetuses when taken by women who are pregnant or become pregnant, according to the Food and Drug Administration (FDA).

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The Food and Drug Administration (FDA) has placed a black box warning on two separate topical testosterone gels following reports of secondary exposure to children, which can cause serious symptoms in children such as enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior. The two drugs listed by the FDA include AndroGel 1 % for topical use and Testim 1 % topical gel.

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Reports of anaphylactic-type reactions, including fatalities, following the administration of Dexferrum (iron dextran injection, USP) used to treat anemia or “iron-poor” blood in people who are unable to take oral iron medication, has spurred American Regent, Inc., makers of the drug, to modify the medicine’s black box warning, and the Food and Drug Administration (FDA) to issue a warning to hematological health care professionals and hospital risk managers.

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An injectable form of a popular anti-nausea medication has received a black box warning by the Food and Drug Administration (FDA) because of a risk of severe tissue injury, including gangrene, requiring amputation. The drug, Promethazine Hydrochloride Injection, formerly known by the brand name Phenergan, is available by pill, suppository and injection. The recall covers only the injectable form.

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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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The Food and Drug Administration (FDA) is requiring a group of popular arthritis drugs to include stronger warning of the increased risk of lymphoma and other cancers in children and adolescents treated with the medication. The warning, which follows an analysis by the FDA of tumor necrosis factor (TNF) blockers, will now be added to the black box warning currently on the products.

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Manufacturers of licensed botulinum toxin (Botox) are now required by the Food and Drug Administration (FDA) to strengthen warnings on its product labeling and add a black box warning – the strongest warning the agency can require – of risk of adverse events when the effects of the toxin spread beyond the site where it was injected. Notice of the safety label update was issued this week by the FDA to cosmetic surgeons, neurologists and consumers.

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“Take comfort in your protection with PROMETRIUM,” reads the tag line on the Web site for a treatment to prevent endometrial hyperplasia in postmenopausal women who still have a uterus and are taking estrogen. But there’s little comfort in the new labeling of the drug, which includes a black box warning of cardiovascular disorders, breast cancer and “probable dementia.”

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