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Weight loss pill warning issued | Weight loss pill warning issued |
(about 22 hours later) | |
A weight-loss drug used by thousands is unsafe for those also taking antidepressants, health watchdogs warn. | A weight-loss drug used by thousands is unsafe for those also taking antidepressants, health watchdogs warn. |
The European Medicines Agency advises patients with ongoing major depression or those on antidepressants against taking rimonabant. | The European Medicines Agency advises patients with ongoing major depression or those on antidepressants against taking rimonabant. |
About 41,000 UK patients have been treated with rimonabant since it was launched in the UK in June 2006. | About 41,000 UK patients have been treated with rimonabant since it was launched in the UK in June 2006. |
Last month US safety officials voted to ban the pill amid concerns about increased suicide risk. | Last month US safety officials voted to ban the pill amid concerns about increased suicide risk. |
Rimonabant, brand name Acomplia, is currently recommended for obese patients with a risk of developing diabetes or cardiovascular disease. | Rimonabant, brand name Acomplia, is currently recommended for obese patients with a risk of developing diabetes or cardiovascular disease. |
It works by blocking receptors in the part of the brain that regulates food intake and the body's ability to break down sugars and fats in the blood. | It works by blocking receptors in the part of the brain that regulates food intake and the body's ability to break down sugars and fats in the blood. |
If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor The Medicines and Healthcare products Regulatory Agency | If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor The Medicines and Healthcare products Regulatory Agency |
The UK's National Institute of Clinical and Health Excellence is currently appraising the drug for use on the NHS. | The UK's National Institute of Clinical and Health Excellence is currently appraising the drug for use on the NHS. |
The EMEA said doctors in the EU had been warned "of the risk of psychiatric side effects" since June 2006 but it was now upgrading this warning. | The EMEA said doctors in the EU had been warned "of the risk of psychiatric side effects" since June 2006 but it was now upgrading this warning. |
But the agency concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants. | |
Evidence suggests that one in 10 people who take rimonabant may develop psychiatric side effects. | Evidence suggests that one in 10 people who take rimonabant may develop psychiatric side effects. |
The commonest psychiatric side effects are low mood and depression. Anxiety, irritability, nervousness and sleep disorders may also occur. | The commonest psychiatric side effects are low mood and depression. Anxiety, irritability, nervousness and sleep disorders may also occur. |
Approximately one patient in every 100 may experience suicidal thoughts. | Approximately one patient in every 100 may experience suicidal thoughts. |
Up to the end of June 2007, the UK's drug safety regulator, the Medicines and Healthcare products Regulatory Agency, had received a total of 318 cases, from UK sources, of adverse drug reactions which were suspected to have been caused by rimonabant. | Up to the end of June 2007, the UK's drug safety regulator, the Medicines and Healthcare products Regulatory Agency, had received a total of 318 cases, from UK sources, of adverse drug reactions which were suspected to have been caused by rimonabant. |
This included 364 psychiatric reactions. Amongst these, there were 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury. | This included 364 psychiatric reactions. Amongst these, there were 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury. |
The MHRA advised: "If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor. | The MHRA advised: "If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor. |
"If you have had depression in the past but feel well on Acomplia, you should continue treatment with Acomplia and discuss your treatment with your doctor at your next routine appointment." | "If you have had depression in the past but feel well on Acomplia, you should continue treatment with Acomplia and discuss your treatment with your doctor at your next routine appointment." |
Sanofi-aventis, the drug company that makes Acomplia, said the product's labelling had been updated accordingly. | Sanofi-aventis, the drug company that makes Acomplia, said the product's labelling had been updated accordingly. |
"Acomplia is now contraindicated in patients with ongoing major depressive illness and/or ongoing anti-depressive treatment. | "Acomplia is now contraindicated in patients with ongoing major depressive illness and/or ongoing anti-depressive treatment. |
"'Special Warnings and Precautions' of the Summary of Product Characteristics (SmPC) have been updated as well to include information on depressive disorders," a statement from the company said. |
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