Washington, DC - January 21, 2014 - U.S. Senator Charles E. Schumer today announced a major push to mandate safety devices on children’s liquid medicine bottles, in order to avoid the estimated 10,000 overdoses that occur each year. Schumer said that these overdoses – scores of which are fatal – can be prevented by installing a device known as a “closed flow restrictor” on to the tops of the medicine bottles. Such devices, which cost less than 10 cents apiece, limit the amount of liquid that can come out of each bottle, making it virtually impossible for children to overdose. The Senator is calling on the Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC) to work together and begin the process of requiring that all liquid medicine bottles intended for children be equipped with these life-saving devices.
Schumer’s push comes after a ProPublica/Consumer Reports investigation outlined how affordable and effective these devices are; the increasing number of children that are ending up in the hospital due to overdoses of liquid medicine; and that the FDA and CPSC have both acknowledged the efficacy of these devices, but have been dragging their feet on implementing them as a requirement. According to a recent study on flow restrictors by the Centers for Disease Control and Prevention (CDC), 100% of young children were able to withdraw medicine from an open bottle of liquid medicine that did not contain a flow restrictor – many of whom were able to do it in under two minutes – but only 11% were able to extract any medicine from a bottle with a closed flow restrictor.
“Flow restrictors will save lives, save money from reduced emergency room visits, and cost almost nothing to implement, so the question is – why on earth wouldn’t we require they be used,” said Schumer. “This is not some fancy, untested technology, far from it – it’s a cheap piece of plastic and rubber that could be the difference between life and death. The FDA and CPSC should get together, figure out how to require flow restrictors and get the ball rolling before another life is lost.”
ProPublica recently teamed up with Consumer Reports and released an in-depth analysis on the issue of flow restrictors in children’s medicine. What they found was that approximately 10,000 children a year end up in the emergency room after overdosing on liquid medicine. They found that, though the number of overdoses had steadily dropped over the last three decades of the twentieth century (as child safety caps became more common), cases have risen about 32 percent since 2004 – a major uptick. Schumer said that these emergency room visits, and the estimated 20 deaths a year they result in, could be avoided if the FDA and CPSC were to require what’s known as a “closed” flow restrictor, but unfortunately very few liquid medicine bottles (5 out of 31 tested by ProPublica and Consumer Reports) have these restrictors.
These devices are covers with small holes that open when punctured by a plastic syringe then reseal when the syringe is removed. There is also what is known as “open” flow restrictors, which are analogous to the plastic tops on hot sauce bottles – they greatly reduce the speed that liquid leaves the bottles, thereby making an overdose less likely. The “open” restrictors cost between 3 and 5 cents, and the “closed” restrictors cost between 8 and 10 cents. Overdoses of liquid medicines usually do not result in death but do have potentially seriously consequences including liver damage, dehydration and vomiting. In addition, there are countless “near misses,” where toddlers get into liquid medicine bottles and parents are unsure whether their child actually ingested any of the medicine, leading to a potentially traumatic experience for both the parents and the child.
As part of their investigation, Consumer Reports found that, by far, the “closed” model works better in preventing the children from accessing liquid medicine. Schumer noted that several manufacturers have voluntary installed both open and closed restrictors, and that the FDA has advocated for voluntary measures for over a decade. He said that it was time to make the most effective version of these devices – the “closed” restrictor – mandatory in order to save lives and keep children safe.
“We believe the FDA and CPSC have the authority to get this done, and they need to get started right away,” said Schumer.
A copy of Schumer’s letter to FDA Commissioner Margaret Hamburg and CPSC Acting Chairman Robert Adler is below.
Dear Commissioner Hamburg and Acting Chairman Adler:
Thank you for your continued work to ensure that drugs sold in the United States are safe for public consumption. I write today urging you to prioritize efforts to reduce the possibility of pediatric medication overdoses. A recent investigation and report published by ProPublica and Consumer Reports highlighted the incidence of overdose in small children and found that the use of effective “flow restrictors” on medicine bottles could dramatically decrease these incidences. In their effort to regulate the safety of drugs in the U.S., the FDA should work to require that flow restrictors be used on all pediatric liquid medicine containers. The CPSC has the ability to set standards for the types of flow restrictors that are to be used such as the "closed" flow restrictors. Together, both agencies should work together to ensure that the safest drug containers are on the market.
As you know, an open flow restrictor is a cover on the neck of a medicine bottle that must be punctured in order to get the liquid medicine out but does not reseal once punctured. A closed flow restrictor works like a valve and requires a plastic syringe to remove any liquid. Consumer Reports found that closed flow restrictors greatly reduce or eliminate the amount of liquid a young child can obtain from a medicine bottle. They noted that while open flow restrictors also reduce the amount of liquid a child could obtain, they were not as effective as the bottles with closed flow restrictors.
A 2013 CDC study found that, in less than two minutes, a child can remove an excess of five doses of medicine from a bottle without a flow restrictor. In total, according to the study, 100% of young children were able to withdraw medicine from an open bottle of liquid medicine that did not contain a flow restrictor – many of whom were able to do it in under two minutes – but only 11% were able to extract any medicine from a bottle with a closed flow restrictor. The ProPublica and Consumer Reports investigation cites that each year over 150 Americans die by accidentally consuming too much acetaminophen, the active ingredient in Tylenol, and according to the Centers for Disease Control and Prevention (CDC), about 20 children die each year from such accidents. An average of 10,000 children will be taken to the emergency room each year after accidentally ingesting an inappropriate amount of medication. Of these visits relating to acetaminophen almost 40% involve ingesting liquid acetaminophen products, meaning thousands of children are at risk of liver failure or death due to an overdose of acetaminophen.
In May 2011 at the FDA’s Center for Drug Evaluation and Research Joint Meeting of the Nonprescription Drugs Advisory and the Pediatric Advisory Committees, the FDA and drug industry experts agreed that putting flow restrictors on medicine bottles would reduce accidental drug overdose by children by limiting the amount of liquid a child can access and consume from a medicine bottle. Some drug manufacturers have voluntarily placed a form of flow restrictor on infants’ and children’s acetaminophen. However, an investigation by Consumer Reports found that only five of 31 over-the-counter products tested have the most efficient flow restrictors.
I ask that your staff work with my office to determine what authority FDA and CPSC currently have to reduce the risk of pediatric overdoses. Specifically, please respond to the following questions so that we may begin to identify actionable steps towards this goal. Have the FDA and CPSC reviewed the current data on “flow restrictors”? Is there adequate data on the efficacy of closed flow restrictors versus open flow restrictors? If FDA determines that changes are needed for public health, what authority does FDA have to classify these restrictors as pediatric medical devices?
The health and well-being of our children should be a priority and we must do all we can in order to ensure that drugs are taken safely and effectively. It is time that the effectiveness of closed flow restrictors be evaluated so that we can move forward with preventing accidental pediatric overdose. Thank you for your attention to this pressing matter. Please do not hesitate to contact me or my staff should you have any questions or concerns.
U.S. Senator Charles E. Schumer