§ Mr. David NicholsonTo ask the Secretary of State for health if he will make a statement on the role of his Department in checking the drug Ativan for harmful side effects and addictiveness.
§ Mrs. Virginia BottomleyWhen the licensing of medicinal products was introduced in the United Kingdom the drug Ativan was already on the market and was therefore given a licence of right. The quality, safety and efficacy was subsequently examined in order that a reviewed product licence might be granted.
The Committee on Safety of Medicines (CSM) carefully monitors reports of adverse reactions to all licensed medicinal products and advises the Licensing Authority when action is required in relation to specific safety issues. The problem of addiction with benzodiazepines, the group of drugs with similar properties to Ativan, has been recognised for a number of years. This problem has been drawn to the attention of the medical profession on a number of occasions and the CSM has recommended restrictions in the use of these substances. The CSM continues to monitor this situation.
§ Mr. David NicholsonTo ask the Secretary of State for Health when his Department first received evidence of the harmful side effects, including addictiveness, from the drug Ativan; and what action was taken to end its availability on prescription.
§ Mrs. Virginia BottomleyThe Committee on Safety of Medicines (CSM) operates a yellow card scheme for physicians to report suspected adverse reactions to drugs. Under the scheme, the CSM received the first report of a suspected reaction to Ativan in November 1973. The first588W report for drug dependence was received in May 1977. It is important to recognise that the report of a suspected adverse reaction does not necessarily imply a causal relationship. Ativan remains available on prescription in the NHS under its non-proprietary name.