Parents demand for prominent warnings to powerful asthma drug

May 19 (Agencies) | Publish Date: 5/19/2019 12:39:24 PM IST

 Makers of a powerful asthma drug that can trigger hallucinations, night terrors and suicidal thoughts could be forced to put prominent warnings on its products.

The Mail on Sunday revealed last week how one in eight children prescribed montelukast end up coming off the drug after suffering mental health problems – even though its psychiatric side effects are officially described as ‘rare’.
Now campaigners have convinced the powerful Food and Drug Administration (FDA) in America to consider forcing manufacturers to include ‘black box’ warnings of potential dangers on information leaflets that come with the tablets. If the FDA agrees, European and UK regulators are likely to follow.
More families have came forward to describe their ordeal, including a mother whose daughter became ‘obsessed with death’, and a 35-year-old woman who endured gruesome hallucinations such as seeing a severed leg on her garden path.
Montelukast, also known by the brand name Singulair, is commonly used by asthmatics as an alternative to steroids taken through an inhaler. It was prescribed almost three million times in England last year and is effective at limiting potentially deadly asthma attacks.
However, there is growing concern at its impact on mental health, with worried parents setting up Facebook groups worldwide.
New York-based campaigner Laura Marotta, who began investigating the drug after her son Nicholas, 12, developed extreme anxiety and paranoia, said: ‘We are asking for a black box warning, the highest the FDA will ever issue. She has already met FDA officials and said a committee will meet in September to examine options.
Dr Andy Whittamore, from the charity Asthma UK, said that ‘for most people, including children, montelukast is a safe and effective treatment’ and that parents should ‘speak to their GP or asthma nurse if they suspect their child is exhibiting unusual behaviours’ and demand a medication review. The UK’s Medicines and Healthcare Products Regulatory Agency said work was under way to add a warning of possible psychiatric side effects to montelukast’s product information. (Stephen Adams and laurence Laluyaux for The Mail on Sunday)

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