§ Mr. WoolasTo ask the Secretary of State for Health how many new born babies in each of the last five years have been damaged by the prescribing of benzodiazepine drugs to their mothers. [93726]
§ Yvette CooperInformation on the number of babies born to mothers taking benzodiazepines during pregnancy who have congenital abnormalities or experience complications is not available. The number of congenital abnormalities and neonatal complications reported to the Committee on Safety of Medicines through the United Kingdom's spontaneous Adverse Drug Reaction Scheme from 1 January 1992 to 31 December 1997 suspected as associated with benzodiazepines is shown in the table.
823W
Number of suspected adverse reaction reports of congenital anomalies and neonatal complications associated with benzodiazepines Year Number 1994 0 1995 0 1996 1 1997 5 1998 2 A report of a suspected adverse drug reaction does not necessarily mean that it was caused by the drug as factors such as underlying disease and concomitant medication may be contributory. The level of reporting of adverse drug reactions with particular drugs is influenced by the scale of drug usage, the period of time the drug has been on the market and the publicity about the drug.
§ Mr. WoolasTo ask the Secretary of State for Health what plans he has to request the Medicines Control Agency to review the use and prescription of benzodiazepine drugs. [93722]
§ Yvette CooperIt is not the role of the Medicines Control Agency to advise on the prescription of medicines. Advice has already been issued in 1998 by the Royal College of Psychiatrists and the Department of Health.
§ Mr. WoolasTo ask the Secretary of State for Health what plans he has to implement the advice of the Committee on Review of Medicines that benzodiazepines should not be prescribed to pregnant women. [93724]
§ Yvette CooperThe product information for prescribers states that benzodiazepines should not be given during pregnancy unless there are compelling medical reasons. There are however some medical conditions in pregnancy where the use of these drugs can be life-saving to mother and child, for example when used to control fits in eclampsia. Patient Information Leaflets produced by the manufacturer and authorised by the licensing authority for benzodiazepines carry warnings that patients should not take the medicine if they are pregnant, might become pregnant or are breast feeding.
§ Mr. WoolasTo ask the Secretary of State for Health what plans he has to implement the advice of the Committee on Review of Medicines on the prescription of benzodiazepine drugs. [93725]
§ Yvette CooperIn 1980, the Committee on Review of Medicines recommended the short-term use only of benzodiazepines, and the addition of warnings about withdrawal reactions and advice on gradual reduction in dosage on cessation of therapy. The licences for benzodiazepines were amended to add these recommendations for use at this time and this was reflected in the product information for health professionals.
Subsequently the Committee on Safety of Medicines has given advice on the use of benzodiazepines. Doctors were informed in the bulletin, "Current Problems in Pharmacovigilance" in 1988. This advice is found in the British National Formulary, which the Department provides to all doctors and pharmacists twice a year.
§ Mr. WoolasTo ask the Secretary of State for Health what plans he has to carry out research into the effects of long-term use of benzodiazepine drugs. [93723]
§ Yvette CooperThere are no plans to carry out research into the long term use of benzodiazepine drugs. The Medicines Control Agency continually monitors the safety of all medicines in routine clinical practice. Benzodiazepines are currently licensed for short-term use only.