In a surveillance study of Michigan Medicaid recipients conducted between 1985 and 1992 involving 229,101 completed pregnancies, 1090 newborns had been exposed to albuterol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 48 (%) major birth defects were observed (43 expected). Specific data were available for six defect categories, including (observed/expected) 9/11 cardiovascular defects, 2/2 oral clefts, 2/ spina bifida, 1/2 limb reduction defects, 0/3 hypospadias, and 6/3 polydactyly. Only with the latter defect is there a suggestion of a possible association, but other factors, including the mother's disease, concurrent drug use, and chance, may be involved (Class IV).
A woman experienced exacerbations of bronchial asthma after taking aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis. On oral challenges, she developed an urticarial reaction after tartrazine; urticarial and bronchospastic reactions after salicylsalicylic acid; and urticarial and bronchospastic reactions after choline magnesium trisalicylate. Non-acetylated salicylates have been recommended for use in aspirin- and/or tartrazine-sensitive patients. The results of sensitivity studies of our patient indicates that such patients may also be sensitive to non-acetylated salicylates.