Australia TGA calls on drug company to improve warnings over children's asthma drug after suicides

03:29  13 july  2018
03:29  13 july  2018 Source:   9news.com.au

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A NSW doctor whose eight-year-old daughter became suicidal after taking a popular asthma Singulair is one of the most popular asthma drugs and is commonly prescribed to children in While the drug did appear to help with the conditions, the anaesthetist said over the next few weeks his

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a woman talking on a cell phone: Sara Hozen© Provided by Nine Digital Pty Ltd Sara Hozen The Therapeutic Goods Administration (TGA) has called on 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.

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Serious asthma -related events – hospitalizations, intubations, death [see WARNINGS AND 3 Number of patients with event that occurred within 6 months after the first use of study drug or 7 In a study of asthmatic children 5 to 12 years of age, those treated with budesonide DPI 200 mcg twice

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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 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.

a close up of a sign: Health Minister Greg Hunt ordered the TGA conduct an urgent review of the warnings given to patients surrounding Singulair's side effects.© Provided by Nine Digital Pty Ltd Health Minister Greg Hunt ordered the TGA conduct an urgent review of the warnings given to patients surrounding Singulair's side effects.

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

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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.

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30 “Suicidality with SSRIs: adults and children ,” The Australian Therapeutic Goods Administration ( TGA Adverse Drug Reactions Bulletin, Col 24, No. 4, Aug. Documents Similar To INTERNATIONAL WARNINGS ON PSYCHIATRIC DRUGS : Suicide Homicide.

Another popular drug , venlafaxine, was shown increase the risk users engaging in suicidal thoughts and attempts at suicide . Mr Branson’s company sued the NHS last year after it lost out on an £82m contract to provide children ’ s health services across Surrey, citing concerns over “serious flaws” in

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 Skerrittand 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.

a group of people posing for the camera: All of these children have had serious psychological breakdowns while taking Singulair, including Sara Hozen (top middle) who took her own life, and Harrison Sellick (bottom middle) who became suicidal at the age of four.© Provided by Nine Digital Pty Ltd All of these children have had serious psychological breakdowns while taking Singulair, including Sara Hozen (top middle) who took her own life, and Harrison Sellick (bottom middle) who became suicidal at the age of four.

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.

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In fact, the FDA has heightened the warnings on the labels several times and convened several hearings about the drugs ' safety and some doctors have called for He also blew the whistle on the widespread pharma myth that a decline in U. S . asthma deaths over the last decade is due to LABAs.

Its findings are particularly worrying because of the increasing numbers of people, including children , who are being given the drugs by their GP for mild depression, and who are not seriously clinically ill. Prozac, the wonder pill of the 1980 s and 1990 s , became the biggest drug company blockbuster of all

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.

a person with collar shirt: Nine.com.au readers have shared their experiences with asthma medication Singulair after an 18-year-old took her own life while taking the drug.© Provided by Nine Digital Pty Ltd Nine.com.au readers have shared their experiences with asthma medication Singulair after an 18-year-old took her own life while taking the drug. 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.”

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