The antihistamine carbinoxamine maleate was first developed in the early 1950s and has been used for decades for the relief of allergy symptoms. The FDA, however, has not approved its use for cough and cold symptoms in children aged 2 and under. As a result of reports of 21 deaths since 1983 in children under 2 who took the medicine, the agency is taking steps to keep most products containing carbinoxamine from pharmacy shelves. These products use the drug without the FDA's approval, having been on the market since before the current FDA drug approval process came into effect.
Now these companies must seek FDA approval if they wish to continue making the drug. Those that do not seek approval must cease making the drug between now and September 8 (90 days from when the FDA took action on June 8) or be subject to additional FDA actions, including sanctions and fines. FDA regulators said that companies marketing the drug for children 2 and under as oral drops must comply within 30 days.
Some pharmacists, however, believe this means that all products containing carbinoxamine have been banned, and they are steering their patients away from the drug altogether. There are about 120 unapproved products containing carbinoxamine with which the FDA must deal. At a news briefing, FDA attorney Deborah Autor, the associate director of the Office of Compliance of the Center for Drug Evaluation and Research, announced that Mikart Inc (Atlanta, Ga) makes the only FDA-approved carbinoxamine products: a tablet marketed as Palgic (4 mg) and an oral solution sold as Palgic Oral Solution (4 mg/5 mL) and Carbinox Maleate Solution (4 mg/5 mL). These formulations are the only ones approved for the treatment of certain allergic conditions in adults and children over 2they are still contraindicated for children under 2, Autor said.
Whereas the FDA does not have a list on its Web site of all drugs with unapproved labeling that are sold in the United States, officials urged those concerned to check its Drugs@FDA Web site at www.accessdata.fda.gov/scripts/cder/drugsatfda/ for a list of drugs that do carry approved labeling. Pharmacists are especially encouraged to consult this site when deciding which products to purchase, Autor said. She said that this action does not affect compounding pharmacies; however, if such a pharmacy is found to be making products containing carbinoxamine, the FDA will take appropriate action.
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