§ Tim Loughton:To ask the Secretary of State for Health if he will make a statement on the (a) availability and (b) side effects of methotrexate. [127554]
§ Miss Melanie Johnson:Methotrexate is a prescription only medicine widely available throughout the United Kingdom. The use of this disease-modifying anti-rheumatic drug (DMARD) has increased in recent 92W years. The National Institute for Clinical Excellence (NICE) has recommended the use of methotrexate and other DMARDs as first line therapy prior to the use of the newer tumour necrosis factor (TNF-a) blockers for the treatment of rheumatoid arthritis (RA).
As with all medicines the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) have continued to closely monitor the safe use of methotrexate. Reports of suspected adverse drug reactions (ADRs) to medicines are collected by the MHRA and the CSM through the spontaneous reporting scheme, the Yellow Card Scheme. To date the MHRA/CSM have received 876 UK ADR reports associated with methotrexate. The most common side effects of methotrexate include nausea, abdominal pain, a reduced number of white blood cells and soreness of the mouth and lips. Other rare but more serious side effects include fibrosis and cirrhosis of the liver, bone marrow suppression and pneumonitis.
In 1997 the product information was amended to advise that patients who receive methotrexate therapy are required to have a full blood count and renal and liver function tests measured on a regular basis. An article was also published in the MHRA/CSM drug safety bulletin "Current Problems in Pharmacovigilance (Vol. 23, September 1997).
In September 2000 health professionals were advised, via another article in "Current Problems in Pharmacovigilance" (Vol. 26 September 2000), to exercise caution when prescribing and dispensing methotrexate. In 2001 the CSM established a working group to review medicines labelling in order to reduce the likelihood of medication error occurring and within the review advised that all oral dose preparations should prominently display a warning to check the dose and frequency of methotrexate on the front face of the carton.
In September 2002 the CSM reviewed the increasing number of UK reports of pneumonitis which had been received by the MHRA in association with methotrexate. The CSM recommended updating the product information to provide clearer guidance to prescribers and patients, recognising that the increase was probably a direct consequence of the recent dramatic increase in methotrexate use in patients with early RA. The MHRA is continuing to work closely with the National Patient Safety Agency to reduce the risk of medication errors associated with methotrexate.