Diet Pill ‘Suicide Risk’
A WEIGHT loss pill used by thousands of dieters has been branded a suicide risk by drug safety officials.
Some 37,000 Britons are taking the prescription-only drug Acomplia, which can help users lose up to 10 per cent of their body weight.
Hailed as an important weapon in the war against obesity, it interferes with the part of the brain involved with cravings.
But yesterday a committee advising the U.S. Food and Drug Administration voted to ban the pill after concerns about its psychiatric side-effects.
The 14-member panel heard testimony that Acomplia increases the risk of suicidal thoughts even in patients without a history of depression.
Its maker, the French pharmaceutical company Sanofi-Aventis, had failed to demonstrate the drug was safe, the panel concluded.
The FDA is not bound to follow the committee’s advice, but the unanimous verdict makes it unlikely that the drug will be approved in the U.S.
Sanofi-Aventis had planned to launch Acomplia – chemically known as rimonabant – last year in America, the world’s biggest drug market.
It forecast annual world sales of more than [pounds sterling]1.5billion. But yesterday shares in the company nosedived, wiping around [pounds sterling]4billion off its market value at one stage.
The European Medicines Agency, which licensed the drug and has the power to order its withdrawal from European shelves, will review the pill’s safety at a meeting next week.
Acomplia was launched in Britain last June, at a cost of [pounds sterling]55 a month.
Since then, there have been 310 adverse reactions, including 152 psychiatric disorders.
UK doctors have previously ruled the drug is safe, even when used by obese patients with heart problems and other complications.
Professor Anthony Barnett, professor of medicine at Birmingham University, said warnings about possible psychiatric side-effects are already available on the drug’s packets.
He said it is ‘of concern’ that U.S.
authorities had rejected the drug, but added: ‘They are being supercautious.
I would expect the European agency to look at their decision.
‘The drug is recommended for obese patients at risk from cardiovascular conditions and diabetes and it helps them lose 5 to 10 per cent of their body weight. But this decision reinforces the fact that there Treat child is a risk-benefit ratio with the drug that means it should not be used in patients without other problems. It’s not something for patients who are a little bit overweight.’ Around 37,000 patients have been prescribed the drug by consultants or GPs since last June, the firm said last night.
The FDA panel reached its decision after examining 49 different Acomplia studies involving more than 13,000 volunteers in Canada, France and the U.S.
Those taking the drug were asked to describe their feelings and 1,200 reports then picked at random for analysis.
Of those taking the drug, two committed suicide, one said they were considering suicide and one was diagnosed as suffering from depression that could lead to suicide. Others users reported suffering from delusions. There were six reports of psychotic behaviour, including a man who tried to strangle his daughter.
In the placebo group – those taking a dummy pill – two people attempted suicide and five talked about it. A spokesman for the European Medicines Agency said the U.S.
decision will be discussed ata meeting next week.
She said warnings about possible psychiatric side-effects could be found on packets and the drug is not recommended for use in patients with depression.
Sanofi-Aventis said it would ‘continue to work closely with the FDA to address the committee’s recommendations’.
* Tamiflu, the drug being stockpiled in the fight against pandemic flu, could increase the risk of teenage suicide, it has been claimed.
Fifty deaths have been linked to the drug, including 14 in teenagers, since it was licensed in 1999.
In Japan, which consumes 60 per cent of the drug’s world supply, two 14-year-olds jumped to their deaths while on the medication. More than 42million people in over 80 countries have received the drug.
Tags: Acomplia, rimonabant, WEIGHT loss pill