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

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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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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Thirty-eight drugs have new labeling approved by the Food and Drug Administration (FDA) outlining new BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS and/or ADVERSE REACTIONS, according to the FDA’s MedWatch July 2009 Drug Safety Labeling Changes posting.

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