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New black box warning for popular children’s asthma medication linked to reports of suicide

Asthma Drug Linked to Suicides To Carry Strong Warning Label in Australia

A commonly prescribed asthma medication, montelukast (sold under brand names like Singulair), will now carry a prominent black box warning in Australia after reports of suicides linked to its use. This decision follows a decade of advocacy from families who believe the drug caused severe neuropsychiatric side effects in their loved ones.

The new warning, approved by Australia’s Therapeutic Goods Administration Advisory Committee (ACM) in August, aims to highlight the potential risk of suicidal thoughts and other mental health issues associated with montelukast. While the scientific evidence on this link remains uncertain, the ACM felt compelled to act after similar warnings were issued in the U.S., Canada, and Europe.

The move comes after a heart-wrenching series of tragedies in Australia. Three suicides have been reported in the past year, and the individuals were only taking montelukast. While these events haven’t been definitively linked to the drug, they highlight the urgency of the situation.

"Sara Hozen took her own life three months after starting on the medication," shared Mary Hozen, an Australian mother who lost her 18-year-old daughter. She told her story in an effort to raise awareness about the potential dangers of montelukast.

Family groups have tirelessly campaigned for better warning labels on the medication for over a decade. Vanessa Sellick, whose son Harrison began experiencing suicidal thoughts and severe tantrums after starting the drug at age two, has been a vocal advocate.

"It’s definitely progress, but there’s still horror and sadness that lives have been lost while we pleaded for action," Sellick said. Her son, now 19, continues to grapple with OCD and anxiety, conditions she attributes to the medication.

The addition of a black box warning is a significant step, but Sellick and other advocates are pushing for even more prominent cautionary labels on medication packaging. They believe a stark visual warning will catch the attention of doctors and patients, enabling them to make more informed decisions about the drug’s use.

The Australian Therapeutic Goods Administration is currently involved in discussions about implementing these additional warning labels, and the Pharmaceutical Society of Australia is also participating in the process.

This situation sheds light on the critical importance of ongoing research and transparent communication about potential drug side effects. While montelukast has proven effective for many patients, its potential risks underscore the need for careful monitoring and open dialogue between healthcare providers and patients.

If you or someone you know is struggling with suicidal thoughts, please reach out for help. You can contact the National Suicide Prevention Lifeline at 988 or the Crisis Text Line by texting HOME to 741741.

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