TGA calls on drug company to add warnings over children's asthma drug

The Therapeutic Goods Administration (TGA) has ordered manufacturers of the asthma medication Singulair to add warnings inside the drug’s packaging about its potential side effects, including suicidal thoughts.

The directive comes after an urgent safety review of the medication ordered by Health Minister Greg Hunt in February in response to a nine.com.au investigation.

However, families who have been campaigning for better warnings about the side effects of the drug - which is commonly prescribed to children aged two and over - say the TGA’s recommendations do not go far enough.

Melbourne mother Vanessa Sellick has been campaigning for better awareness about Singulair’s side effects since 2013, and helps run a Facebook group of more than 5000 members who claim to have been adversely affected by the drug.

Both of Ms Sellick’s sons were prescribed Singulair from the age of two, but it was her eldest, Harrison, who reacted the most severely to the drug.

Harrison, now 12, began having severe tantrums that would last for hours and, at just four years old, he began having suicidal thoughts.

Ms Sellick said her son was in the bath one day when he began begging her to kill him in graphic detail.

While the TGA’s actions were a step in the right direction, Ms Sellick said mandating warning labels on the outside of the packaging would have been a more appropriate response.

“This medication has been linked to death by suicide in Australia and overseas,” she said.

“A visible warning label on the outside of the packaging is vital in ensuring patients or their carers are reminded to constantly monitor for changes in mood and behaviour.

“Due to the nature of the side effects that can present at any time during use. Without these labels we fear that many families will not make the link between the side effects and montelukast.”

Nine.com.au’s investigation told the stories of Australian parents left devastated after their children suffered serious psychotic breakdowns while taking the drug, including children as young as four becoming suicidal.

All of the families said they had not been warned by doctors or pharmacists about the medicine’s potential side effects, which can include increased aggression, nightmares, depression and suicidal thoughts.

Australian mother Mary Hozen told how her teenage daughter Sara took her own life in the US three months after she started taking Singulair.

The drug - which is also known by its generic name montelukast - has already been linked to one death by suicide in Australia this year, according to a report received by the TGA.

The findings of the TGA’s safety review, which was overseen by a panel including the head of the TGA John Skerritt and the TGA’s chief medical advisor Tim Greenaway, were released this morning.

The TGA said it had written to the all the manufacturers of montelukast, requesting that consumer medicine information (CMI) leaflets be included inside the drug’s packaging.

Currently, the only way patients and their families can read about the drug’s side effects is by looking online or requesting a print out from their pharmacist.

The TGA said it also written to all state and territory health departments to make sure advice about montelukast and neuropsychiatric events was included in guidelines for doctors.

According to the TGA, more than 200,000 prescriptions for Singulair were issued in 2016-2017.

In the past five years, the TGA received 179 reports of adverse events from Australian patients being treated with the drug, including 38 reports of a patient becoming suicidal.

National Asthma Council director Bastian Seidel said Singulair was often used as a last resort option for patients whose asthma could not be controlled by other medications and could be life-saving for severe asthma sufferers.

“It is a drug that works well for quite a few patients who have tried everything else. For them it’s literally a lifesaver. No doubt about it, from some patients it’s a complete game changer,” Dr Seidel said.

“But for some there are adverse reactions and we should take them very seriously and really discuss with parents what are the benefits and potential negative reactions to the drug.”