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

The safety labels on Long-Acting Beta Agonists (LABAs) used for the treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD) now carry a black box warning about LABAs increasing the risk of asthma-related death, according to the Food and Drug Administration (FDA). A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events. The new recommendations in the updated labels also state that use of LABAs alone without the use of a long-term asthma control medication, such as an inhaled corticosteroid, is “absolutely advised against” in the treatment of asthma.

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The Food and Drug Administration (FDA) has placed a new black box warning on Arava (leflunomide), a drug used to treat rheumatoid arthritis, because it can increase the risk of severe liver injury. The drug’s current Boxed Warning states that lefluonmide is contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception, because the drug could harm the fetus.

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The safety label of the antidepressant Wellbutrin XL and Wellbutrin SR (bupropion HCL) has been updated to include a notice to consumers not to chew, divide or crush tablets as doing so may lead to an increased risk of adverse effects, including seizures, according to a Food and Drug Administration (FDA) safety labeling update.

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A drug used to treat hyperthyroidism, including Graves’ disease, has been linked to cases of severe and sometimes fatal liver injury and acute liver failure in both adult and pediatric patients, according to the Food and Drug Administration (FDA). The agency this week alerted consumers and health care professionals that propylthiouracil now carries new black box warning about the increased risk of serious liver injury including liver failure and death in patients who take the drug.

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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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