Paragraph 4 reads: "The evidence, according to them, is lying on the dining table in their lounge room the day the mother and I meet. It is an empty packet of the antidepressant Zoloft. Their daughter took half a 50mg tablet for three days, as instructed by her doctor, then on the fourth day emptied the rest of the packet down her throat in one long gulp."

http://www.theaustralian.news.com.au/story/0,25197,24371631-23289,00.html

Suicide attempt a depressing drug side effect

Julie-Anne Davies | September 20, 2008

THIS is a story that can be interpreted in more ways than one. It's about a 14-year-old Melbourne schoolgirl whom we'll call Sarah. When you're 14, you don't want the rest of the world knowing your business, especially not the bit about the time you overdosed and wound up in hospital.

She is aware her mother has contacted a newspaper to talk about that evening three months ago but she doesn't want any part of it herself. She's still shocked at what she did and is flat out trying to figure out why.

But her parents believe they have discovered the clue to what led to their middle child's uncharacteristic and desperate act.

The evidence, according to them, is lying on the dining table in their lounge room the day the mother and I meet. It is an empty packet of the antidepressant Zoloft. Their daughter took half a 50mg tablet for three days, as instructed by her doctor, then on the fourth day emptied the rest of the packet down her throat in one long gulp.

Sarah had been prescribed the drug to treat what her psychiatrist and her parents agreed were worrying episodes of depressive symptoms.

"She'd had a rough couple of years because she had injured her hip and had been in pain for a long time," her mother explains." She had two operations last year and another in May. It was before the last bout of surgery that she expressed the thought that she didn't want to wake up after the operation.

"It wasn't a threat, she didn't have a plan, but it was enough for us to get her to our doctor and then on to a psychiatrist pretty quickly."

And this is where they believe Sarah's problems suddenly got a whole lot worse.

They claim they were not warned by the psychiatrist who prescribed the antidepressant that it carried an increased risk -- between 2 per cent and 4 per cent -- of causing suicidal thoughts and self-harm in children and young people in the first weeks of use.

Crucially, they were not told their daughter would require close monitoring because of this risk. They were also not informed that the drug is not recommended for treatment of depression in children by either Australia's drug monitoring agency, the Therapeutic Goods Administration, or the drug company Pfizer, which markets Zoloft in Australia. And they were not given a copy of the consumer medicine information leaflet that is supposed to detail these issues when they bought the drug.

However, as they later learned, even if they had got a copy of the leaflet, it would not have told them much of this anyway.

"I am not from the dark ages where people just happily went along with what the doctor says," Sarah's mother says. "I quizzed the specialist about potential side effects because we were concerned about putting our 14-year-old child on antidepressants and we wanted to make an informed decision. It turns out despite our best efforts, we didn't."

The parents claim the first they learned of the increased suicide risk associated with this class of antidepressant was late in the evening after Sarah had been rushed to the emergency department of a Melbourne hospital after overdosing.

"The psychiatrist who treated her told us that suicide attempts were not uncommon in the early days of treatment on these drugs," her mother says. "He told us that kids are sometimes hospitalised when they first go on these drugs because of this risk.

"I believe there is a place for these drugs but you have to know what you're getting into, and we didn't."

It is hard to argue against a mother's plea for informed consent. Good doctors, says the Australian Medical Association's John Gullotto, consider all non-pharmaceutical possibilities before embarking on antidepressant treatment in children. "It's the last resort, not the first," Gullotto says.

If doctors do not outline the side effects of these drugs, then the next best source of information is the pharmacist. The federal Government pays pharmacists 10c a script to distribute consumer medicine information sheets supplied by drug companies which outline side effects and warnings about a medication. But there is no law in Australia that compels pharmacists to comply, so many don't do it.

Shane Jackson, vice-president of the Pharmaceutical Society of Australia, which represents pharmacists, agrees his industry is failing in its duty to properly inform patients. "We know we have to lift our game, no question," Jackson says. But he argues the present emphasis in many drug company information leaflets is weighted too heavily towards possible negative side effects rather than balancing this with the positive impact the drug will have.

Then there's the obvious rejoinder to Sarah's parents' understandable attempt to find an explanation for why their teenage daughter tried to kill herself. How do you unpick the cause of a suicide attempt in a person who is depressed?

The message from drug companies depends on who they are talking to.

Pfizer couches its suicide warning in its consumer medicine information in terms of the underlying depression, warning the symptoms may be worse for the first two months until the drug takes effect. Nowhere does it state that the drug can increase the suicide risk.

In its product information to doctors, it is a different story. In this document it describes the increased risk shown in clinical trials and warns that close monitoring of children is vital in the first two months of treatment.

The pharmacist who dispensed the medication to Sarah's parents has reported her overdose to the TGA's adverse drug reactions unit. He tells Inquirer it is the second such report in the past six months.

The TGA, through its advisory committee, has been telling healthcare professionals since 2004 to notify it of any suspicious reactions to antidepressants because of concerns about these drugs and their use in children.

"Even if Sarah's attempt had nothing to do with the drug, the case should have been reported," the pharmacist says.

The hospital has told the family it has made no report, as it does not believe the overdose is related to the medication. The psychiatrist has not reported the matter either, instead telling the family that one of the benefits of Zoloft is that it is a relatively safe drug to overdose on. The girl's family has made its own report to the TGA.