Safety Of Childhood Use Of Singulair And Opioids Subject Of FDA Advisory Committee Meeting

Federal health officials will be holding a meeting next month to discuss the safety of opioid prescription medications used to manage pain in children, and evaluate the results of a study about the risk of neuropsychiatric problems linked to Singulair, which has become a popularly prescribed pediatric asthma medication.

The U.S. Food and Drug Administration (FDA) announced that the agency will be holding a prescription drug review meeting with the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee on September 26 and 27, to discuss safety reviews of opioid and Singulair prescription treatments used for pediatric patients.

The two-day meeting comes amid growing concerns surrounding the nation’s opioid crisis and as new research suggests the prescription drug montelukast, more commonly known as Singluair, may cause a variety of harmful side effects in children.

On the first day of the meeting, the agency and committees will discuss the required pediatric-focused safety review for the prescription of OxyContin extended-release opioid tablets and review appropriate types of treatments and dosages for pediatric use.

While opioid analgesics serve an important medical purpose for treating conditions that cause chronic pain in pediatric patients with cancer, sickle cell disease, traumas, burns and various other ailments, officials warn these medications must be prescribed in a way that does not expose the nation’s youth to opioid addiction.

The opioid crisis has been largely driven by inappropriate doctor prescribing, especially without a documented pain diagnosis, experts say. Now, more people have easier access to prescription drugs and illicit drugs, including heroin or fentanyl.

Earlier this year, in a study published in the Journal of Studies on Alcohol and Drugs, researchers discovered the powerful pain medications account for nearly 70% of all drug overdose deaths. In addition, the rate of deaths from drug poisonings among teens and young adults increased from 8 per 100,000 people in 2006, to nearly 10 per 100,000 people by 2015, with the majority of overdose deaths caused by prescription painkillers and opioids.

The second day of the meeting will focus on hearing information about new neuropsychiatric events associated with the use of Singulair; an asthma medication developed by Merck & Co. and is part of a class of drugs known as leukotriene receptor blockers. It is the third-most prescribed brand name drug in the United States, estimated to be prescribed to over 2 million pediatric patients up to 16 years of age.

In 2009, the label for leukotriene modifiers was updated to include a warning for psychiatric events such as agitation, anxiety, depression and suicidal thoughts and actions. This prompted the FDA to launch a study in 2017 to focus on the potential neuropsychiatric events that may arise from the use of the medication.

The results of that study have now become available and will be discussed, focusing on the findings surrounding the drug’s potential association with depression, self-harm and suicidal events.

Earlier this year, Public Citizen urged the FDA to ban the over-the-counter sale of Singulair Allergy, a drug proposed by Merck in May. According research conducted by the group, Singulair Allergy had minimal benefits, but poses potentially serious health risks.

The conclusions of the FDA’s advisory committees are not binding, but often form the basis for critical FDA policy and procedure decisions.