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

  • Written by: Russell Maas
  • 1 Comment

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.

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1 comment

  1. Vanessa Reply

    The FDA have stated that they reopened their safety review into Montelukast due to public feedback. In 2017, the Montelukast (Singulair) Side Effects Support and Discussion Group (that now has over 7100 members), in collaboration with Parents United for Pharmaceutical Safety and Accountability, sent a letter to the FDA asking for a black box warning, acknowledgment of long-term side effects and protracted withdrawal, the addition of some side effects, for an acknowledgment that the side effects are common in children as per current research and not rare as currently listed and for further research into the mechanisms that cause the neuropsychiatric side effects (amongst other things). Additionally, our group provided an in-depth survey of affected individuals.
    In 2018, one of our members made a presentation to the FDA, outlining the severe impact these side effects had on her child and family.
    In our group we sadly have six families that have lost their loved ones to suicide. All these families believe that Montelukast caused the suicides except one family where they believe the cocktail of Tamiflu and Montelukast caused the death by suicide.
    The severely negative impact this medication is having across the globe is horrific. Little is understood about why some suffer so significantly and others do not. No child should suffer the suicidal ideation that many of our children suffer. No parent should have to hear their young child beg them to die.
    We need increased safeguards around this medication. For our children, the benefits did NOT outweigh the risks.

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