Consumers who have been injured by Children’s Motrin have commenced lawsuits against the drug maker, McNeil Laboratories, and McNeil’s parent company, Johnson & Johnson. These actions allege that these companies were aware of the link between Children’s Motrin and other Ibuprofen medicines and failed to adequately warn consumers and physicians of this risk.
Critics of these companies have urged the U.S. Food and Drug Administration (FDA) to mandate labels for Children’s Motrin that warn of the risk of SJS from use of Children’s Motrin and the potentially fatal consequences of using this medicine.
The labeling issue is complicated by the FDA’s mandated warnings (beginning in 1974) about SJS and the related condition, TEN (toxic epidermal necrolysis), for prescription forms of this medication. When Children’s Motrin became available without a prescription (over the counter) in 1995, the warning labels were no longer included.
In one Children’s Motrin / SJS case, the court noted that the maker of Children’s Motrin received at least 117 reports (beginning in June 2005) of SJS and TEN related to use of Children’s Motrin and other Ibuprofen drugs. McNeil received 87 of these reports before June 2009, when there was no mention of the risk of SJS or TEN on the non-prescription Children’s Motrin label.