The US Food and Drug Administration (FDA) has announced a meeting with the Pediatric Advisory Committee to evaluate the use of prescription medication containing opioids when treating coughs in children. A statement by FDA Commissioner Scott Gottlieb, MD, highlighted the potential risks of these medicines and the FDA's intention to further explore the issue.
In 2013, the FDA changed labeling regulation to ensure any prescription codeine labeling contained a Boxed Warning and Contraindication for children up to 18 years of age. This is because there is a danger of life-threatening respiratory depression following codeine use for pain management in children who have undergone a tonsillectomy or adenoidectomy.
This year, on April 20th, the FDA announced further changes to laws regarding the labeling of prescription codeine products in an effort to better protect children from the risks associated with opioid medication. These included adding a Contraindication to the labels, alerting parents that codeine should never be used to treat coughs in children under the age of twelve.
In his most recent statement, Gottlieb highlighted the importance of addressing the issue of opioid medication use when treating children, saying: "It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions."
The FDA will continue to evaluate this issue and is currently funding research to "develop comprehensive, consumer-centered approaches on best practices for the safe use of pediatric cough and cold medications generally," he added.
Furthermore, the agency has also released a guide for parents on when children need medicine to treat their coughs and colds and how to ensure it is administered safely. It warns against use of codeine products in children under 12 years of age. The guide also advises against using these medications in youths aged 12-18 who are obese, or who have breathing conditions, such as severe lung disease or obstructive sleep apnea.
In the guide, Amy M Taylor MD, MHS, observes that in many cases, over-the-counter medications may help to relieve symptoms, but will not change the "natural course of the cold or make it go away faster". The FDA pediatrician explained the suppression of a cough is not always desirable, as coughing helps clear mucus from the lungs, protecting the lungs.
Parents with a baby three months old or younger should call a pediatrician at the first sign of illness, but any parent worried about their children's symptoms should not hesitate to call their pediatrician for advice, Taylor added. The FDA also advised parents to call a healthcare professional if children display any of the following symptoms:
- A fever in an infant 2 months or younger.
- A fever of 102 degrees or higher at any age.
- Signs of labored breathing, including nostrils widening with each breath, wheezing, fast breathing, the ribs showing with each breath.
- Blue lips.
- Not eating or drinking, with signs of dehydration.
- Ear pain.
- Excessive crankiness or sleepiness.
- If a cough lasts for more than three weeks.
- If the child is getting worse.
The FDA suggested a number of alternatives to medication to help alleviate the uncomfortable symptoms of coughs and colds in children. These included installing a cool-mist vaporizer or humidifier to moisten the air and decrease the drying out of nasal passages and the throat. Saltwater drops or saline spray may also help to loosen mucus in children with a stuffy nose. Administering acetaminophen or ibuprofen, which are available over-the-counter, may help to alleviate fever, aches and pains. However, the FDA urged parents to ensure they use the correct dose.
Parents with questions about their child's medication or over-the-counter options were advised to speak to their pediatrician or ask a pharmacist for advice. Taylor noted that pharmacists can provide information on how much medication to give children and how to correctly administer the dose.