CPSC Requires Safety Closures For Ibuprofen Medicines

The U.S. Consumer Product Safety Commission (CPSC) voted unanimously to issue a mandatory requirement for child-resistant packaging for over-the-counter ibuprofen medicines. The Commission took this step because of the large number of poisonings, and the potential for serious side-effects to young children who accidentally swallow ibuprofen sold in non-child-resistant packaging.

Ibuprofen, a pain-killer and anti-inflammatory medicine, originally was available by prescription only and therefore was required to be dispensed in child-resistant packages, unless requested otherwise. Since 1984, however, ibuprofen has been available over-the-counter. When a prescription medicine is granted over-the-counter status by the Food and Drug Administration, the medicine is no longer subject to the child- resistant packaging requirements for oral prescription medicines. Aspirin and acetaminophen, two other pain-killers available over-the-counter, are already required to be available in child-resistant packaging.

Increased use since 1984 of ibuprofen without child-resistant packaging has resulted in an increase in the number of accidental ingestions by young children. Approximately 29,000 ingestions of over- the-counter ibuprofen by children under age five were reported to poison control centers during the five years following the medicine's over-the- counter availability. The CPSC knows of two deaths of young children who swallowed ibuprofen. Therefore, the CPSC voted to issue this regulation to require over-the- counter ibuprofen to be available in child-resistant packaging.

The CPSC is issuing this Poison Prevention Packaging Act regulation as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. Child-resistant packaging saves lives. For oral prescription medicines alone, CPSC estimates that more than 400 children's lives have been saved since 1974. The Commission's objective is to reduce the estimated 28.5 million injuries and 21,600 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction.