Weight-loss drug Rimonabant has been approved for use on the NHS.
The National Institute for Health and Clinical Excellence (NICE) has announced the drug will be made available to overweight or obese people who have had no success with making life style changes or who cannot take the two other weight loss drugs Orlistat and Sibutramine.
In considering Rimonabant, concerns regarding the potential for adverse affect on mood and its safety profile were noted. As a result NICE recommends careful and comprehensive assessment for depressive disorders/mood alterations before Rimonabant is prescribed, and regular monitoring for signs of depression or other mood alterations.
It comes after concerns about Rimonabant's possible side-effects, including suicidal thoughts and depression. Last month the Medicines and Healthcare products Regulatory Agency (MHRA) said that it had received 720 reports of adverse drug reactions (totalling 2,123 individual reactions) in the UK since the drug launched in 2006.
Five resulted in death and 974 involved psychiatric disorders, of which 48 reports involved suicidal thoughts.
A total of 93 involved depression, 32 involved panic attacks while others related to, among other things, inability to sleep, mood swings and tearfulness.
The drug went on sale in the UK in June 2006 but approval from the National Institute for health and Clinical Excellence for use on the NHS has only just been issued.
“Diabetes UK advises that the first and best method of weight loss is eating a healthy diet and taking regular physical activity,” said Diabetes UK Care Advisor Jemma Edwards.
“The decision by NICE to make Rimonabant available as a treatment option to a limited number of appropriate people has provided healthcare professionals and people with diabetes another option to help initiate weight loss," she added.
“Anyone worried about taking Rimonabant should discuss this with their healthcare professional. It should be noted that people with severe depression, those that take anti-depressants and those with severe renal impairment are advised not to take this drug.”
“We know that people with diabetes have a higher risk of developing depression and this must be considered before the drug is prescribed. Diabetes UK recommends that a comprehensive assessment for depression/mood alteration is undertaken by a competent professional before Rimonabant is prescribed and that patients are monitored throughout the course of their treatment.”
People in the UK, Germany, and France are the highest users of Rimonabant worldwide. It has not yet been authorised in the US due to safety fears.