The prominent watchdog group Consumer Reports is calling for safer liquid medication bottles for Infant Tylenol to reduce the risk of acetaminophen poisoning.
While the FDA has called on manufacturers of children’ drugs to use flow restrictors, Consumer reports indicates that different types of the safety device used by different manufacturers have vastly different rates of success at preventing children from consuming large quantities of the medication.
In an article published earlier this month, Consumer Reports indicates that Johnson & Johnson’s McNeil subsidiary continues to use a less-effective flow restrictor for Infant Tylenol liquid medication bottles, indicating that other designs may be much better.
In 2013, Consumer Reports tested a number of flow restrictors used on more than 30 different infant and children’s acetaminophen bottles. They found that of the two types, one design used in PediaCare products and by DG Health, worked better than the other commonly used type. Infant Tylenol did not use an effective flow restrictor, Consumer Reports found, and McNeil recently confirmed that it is still using the same flow restrictor that was used during the 2013 testing.
“We’d like to see all manufacturers using the more effective valve,” Dr. Doris Peter, director of the Consumer Reports’ Health Ratings Center, said in the report. “Well-designed flow restrictors should be used on all liquid medications for adults and children.”
Acetaminophen Health Risks
The active ingredient in Infant Tylenol, acetaminophen, can pose a serious and potentially life-threatening risk if excessive doses of the medication are taken by children. Given the desirable taste of the medication for many children, flow restrictor caps serve an important purpose of reducing the risk of accidental acetaminophen overdose.
In recent years, concerns have increased over the risk of liver damage from acetaminophen, which can result in liver failure and the need for a liver transplant. It has also been liked to dangerous skin reactions, like Stephens-Johnson Syndrome.
Tylenol and other acetaminophen products have been identified in recent years as a leading cause for liver injury in the United States. The FDA has indicated that more than 50,000 emergency room visits each year, including 25,000 hospitalizations and over 450 deaths annually, may be linked to acetaminophen.
Efforts have been made in recent years to increase awareness about the potential risks of acetaminophen overdoses, and to reduce the amount of liver injury cases linked to the popular analgesic. However, those efforts have not included requirements that a more effective flow restrictor be used on bottles of Infant Tylenol.
Johnson & Johnson currently faces a number of Tylenol lawsuits brought by individuals throughout the United States, alleging that the drug maker has withheld important safety information from the public for decades. Plaintiffs claim that a false impression has been built that Tylenol is safe, while failing to adequately warn about the risk of liver failure.