Carbinoxamine Products Still Within Reach

The antihistamine carbinoxaminemaleate was first developed inthe early 1950s and has beenused for decades for the relief of allergysymptoms. The FDA, however, has notapproved its use for cough and coldsymptoms in children aged 2 and under.As a result of reports of 21 deaths since1983 in children under 2 who took themedicine, the agency is taking steps tokeep most products containing carbinoxaminefrom pharmacy shelves. Theseproducts use the drug without the FDA'sapproval, having been on the marketsince before the current FDA drugapproval process came into effect.

Now these companies must seek FDAapproval if they wish to continue makingthe drug. Those that do not seek approvalmust cease making the drug betweennow and September 8 (90 days fromwhen the FDA took action on June 8) orbe subject to additional FDA actions,including sanctions and fines. FDA regulatorssaid that companies marketingthe drug for children 2 and under asoral drops must comply within 30 days.

Some pharmacists, however, believethis means that all products containingcarbinoxamine have been banned, andthey are steering their patients awayfrom the drug altogether. There areabout 120 unapproved products containingcarbinoxamine with which theFDA must deal. At a news briefing, FDAattorney Deborah Autor, the associatedirector of the Office of Compliance ofthe Center for Drug Evaluation andResearch, announced that Mikart Inc(Atlanta, Ga) makes the only FDA-approvedcarbinoxamine products: atablet marketed as Palgic (4 mg) and anoral solution sold as Palgic OralSolution (4 mg/5 mL) and CarbinoxMaleate Solution (4 mg/5 mL). Theseformulations are the only onesapproved for the treatment of certainallergic conditions in adults and childrenover 2—they are still contraindicatedfor children under 2, Autor said.

Whereas the FDA does not have a liston its Web site of all drugs with unapprovedlabeling that are sold in the UnitedStates, officials urged those concerned tocheck its Drugs@FDA Web site atwww.accessdata.fda.gov/scripts/cder/drugsatfda/ for a list of drugs that do carryapproved labeling. Pharmacists areespecially encouraged to consult thissite when deciding which products topurchase, Autor said. She said that thisaction does not affect compoundingpharmacies; however, if such a pharmacyis found to be making products containingcarbinoxamine, the FDA will takeappropriate action.