August 13, 2015 — The FDA has issued “guidance to industry” recommending flow-restrictors on over-the-counter liquid medications for kids that contain acetaminophen to reduce the risk of accidental overdoses, severe liver damage, and death.
Flow-restrictors fit onto the top of a bottle and help prevent children accidentally squeezing out too much liquid medicine. Studies show that about 10,000 children visit the emergency room every year after overdosing on liquid medicine.
According to ProPublica, FDA experts have been recommending flow-restrictors to prevent accidental acetaminophen overdoses since at least 2001.
In 2013, Consumer Reports also advocated industry-wide adoption of flow-restrictors on liquid medications for adults and children, including cough and cold medication.
The FDA does not require flow-restrictors, but many drug-makers voluntarily use them on pain or fever medicines for infants and children. The problem is that flow-restrictors remain uncommon on other liquid medicines for children.
McNeil Consumer Healthcare, a unit of Johnson & Johnson that sells Infants’ and Children’s Tylenol, voluntarily installed flow-restrictors on medicines in 2011. The company told ProPublica they are considering using them on other pediatric medicines, such as Benadryl, Sudafed PE, and Motrin.
McNeil is now facing over 200 lawsuits from people who accidentally overdosed on Tylenol after using it as directed. The lawsuits have been centralized in a Multi-District Litigation (MDL No. 2436) in the U.S. District Court for the Eastern District of Pennsylvania.