A new black box warning will be added to an asthma drug linked to three reported suicides in Australia in the past year.
The decision comes after more than a decade of lobbying by families about the potentially dangerous side effects of the drug montelukast, sold as Singulair.
This medication is sold in chewable tablets and is commonly prescribed to children, but adults can also use it.
Some parents said their children suffered serious side effects while taking the drug, including nightmares, behavioral changes and, in rare cases, suicidal thoughts.
The decision follows similar moves overseas, where the United States, Canada and Europe added black box warnings to products containing montelukast.
The ACM said in a conference statement that the evidence of a potential link between montelukast and neuropsychiatric risks remains uncertain, but that a black box warning would prompt “Australia to engage with international regulators” and “consume “We recognize the concerns of those concerned.”
Since then, the U.S. Food and Drug Administration has released initial results from an internal study it conducted on the effectiveness of montelukast.
The results, presented last month at the American Society of Toxicology, showed that montelukast binds to multiple brain receptors important for mental function, although it has not yet been peer-reviewed.
Anyone can report adverse events, including patients, doctors, and family members. These reports have not been confirmed by the TGA and do not prove a causal relationship between the drug and side effects.
In all three cases of people who took their own lives, the only drug known to have been taken by them was montelukast.
Back in 2018, the TGA investigated the possible neuropsychiatric side effects of montelukast following a series of articles by 9news.com.au about children and adults suffering from nightmares and suicidal thoughts while taking the drug. They announced that they would be adding information about sex to their articles. Product information inside the box.
Vanessa Sellick is a Melbourne mother who has been campaigning for warning labels on medicine packaging for 11 and a half years.
Selick said that while the new black box warning is another step in the right direction, the announcement caused “mixed emotions.”
“While we are excited about this progress, we also know that there have been three additional montelukast-induced suicides this year in Australia, which is unacceptable,” she said. spoke.
“We’ve been advocating for 11 and a half years, and people are still dying from this drug.”
Sellick’s son Harrison, now 19, started taking Singulair when he was 2 years old.
She said she had severe tantrums that could last for hours, and that she started having suicidal thoughts when she was 4 years old.
Sellick described in graphic detail that one day while her son was taking a bath, he began begging her to “kill him.” At the age of five, he made an attempt on his own life.
Sellick said Harrison was still suffering from the effects of drugs at a young age.
“One of the recognized side effects of (montelukast) is obsessive-compulsive disorder, and that’s probably what will cause Harrison the most trouble,” Selick said.
“His obsessive-compulsive disorder makes it difficult for him to carry out daily activities. He still suffers from anxiety and suffers from bouts of depression.”
Sellick, who along with another parent, Jocelyn Suter, runs a patient advocacy group for people affected by montelukast, said more could be done to stop the suffering of others. He said it was necessary.
“What we want now is actually a fluorescent sticker on the outside of the package, called a caution label,” Selick said.
In Australia, some drugs have warning labels on the outside of their packaging, such as those that should not be taken while operating heavy machinery, but there are currently no warning labels on drugs associated with neuropsychiatric side effects. It is not posted, Selick said.
Mr Sellick and Mr Suter’s group are working with the Pharmaceutical Society of Australia and the TGA and have begun a consultation process on the warning label for montelukast.
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