Several drugmakers have recalled over-the-counter cough and cold products for infants over concerns about fatal overdoses, Reuters reports. Johnson & Johnson Wyeth and Novartis are among those recalling medicines; CVS said it will remove the products and generic equivalents. One professor took the criticism one step further: “There are really no good studies demonstrating that these medications work.”
The trade association representing the companies stressed the drugs are safe when used as directed; Food and Drug Administration reviewers have called for warnings saying the medicines are unsafe for very young children. Fifty-four deaths with decongestants and 69 with antihistamines were reported in 1969-2006. The FDA will meet with outside advisers before making firm decisions on new instructions.