Wake Smith & Tofields is expecting an increase in the number of cases related to the slimming pill Acomplia following news this week that doctors have been told to stop prescribing the anti-obesity drug because it poses a risk of psychiatric disorders and suicide.
The European Medicines Evaluation Agency recommended suspension of the drug yesterday amid concerns that it may increase depression, sleep depression, sleep disorders, anxiety and aggression in some overweight or obese patients.
An estimated 97,000 patients in the UK have been prescribed Accomplia and 20,000 are currently taking it. John Vallance, Partner in the Medical Negligence Department at Wake Smith & Tofields, discusses the issues:
"Wake Smith & Tofields is providing professional advice in relation to this drug. In one case a client has developed psychiatric side effects believed to have been triggered by the drug which have continued despite them discontinuing their use of Acomplia. In this case the drug was prescribed in 2007, when it was licensed for use in Europe, but before the recent approval by NICE. It was not however until July 2007 that the manufacturers started to carry warnings in relation to possible adverse psychiatric reactions.
"The slimming drug shot to fame in the UK in June 2008 amidst a torrent of tabloid headlines claiming that the drug had startling side effects and was linked to suicide. The drug has indeed been banned in the US due to concerns that it increases the risk of suicide. The Food and Drug Administration, the body which approves drugs in the US, suggests that 10% of those using the drug may develop mental side effects including depression.
"Patients who are prescribed drugs via the NHS or their GP are entitled to assume that the medication is reasonably safe. It is imperative that they are warned of all possible side effects of any drug they are going to take prior to beginning the course of medication. We have been asked to investigate whether Acomplia may have been prescribed in inappropriate circumstances when either its use was contradicted or patients were not adequately warned of the very serious side effects. We would advise patients who are concerned about the possible effects following recent announcements not to take any steps with their medication without consulting their GP".
Acomplia (known as Rimonabant in the US) was launched in the UK in June 2006 following approval from Government drugs watchdog, the National Institute for Health and Clinical Excellence (NICE). The weight loss drug is for the use of obese and overweight patients with type 2 diabetes or dyslipidaemia (a disruption in the amount of lipids in the blood) and is recommended to treat patients in conjunction with a healthy diet and regular exercise programme.
Vallance continues: "We all want the best treatment available; however, sometimes when new drugs are introduced into the market, prescribers may act too hastily in passing on treatment to their patients. In some cases we are seeing a failure to monitor patients sufficiently closely. We also think that more attention should be paid to ensuring that medication is withdrawn or changed when side effects, that cause concern, develop."
The Medicines and Healthcare products Regulatory Agency (MHRA) which is responsible for drug safety in Britain, said doctors should not issue any new prescriptions for Acomplia. The EMEA has advised patients concerned to consult their GP but said there is no need to stop taking the drug immediately.
If you have experienced problems related to taking to a licensed drug and would like to discuss your legal options, please contact the medical negligence team at Wake Smith & Tofields on 0114 266 6660 or email [email protected].
