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Complementary Medicine

Volume 487: debated on Tuesday 10 February 2009

To ask the Secretary of State for Health what assessment his Department has made of (a) the side-effects of (i) Vioxx, (ii) SSRI antidepressants and (iii) Salmeterol and (b) the use of complementary and alternative medicines to treat the conditions such drugs were developed to address. (254114)

The safety and efficacy of medicinal products is formally assessed from clinical trials submitted at the time of marketing authorisation. These data are carefully evaluated by the independent scientific advisory committee, the Commission on Human Medicines (CHM), and the Medicines Healthcare products Regulatory Agency (MHRA) prior to authorisation for evidence that the products work and are acceptably safe. The longer term safety of the use of medicines in routine clinical practice is closely monitored by the MHRA, including reports of suspected adverse drug reactions (ADRs) submitted by health professionals and patients through the Yellow Card scheme, to ensure that benefit risk balance continues to be favourable.

The safety of Vioxx (rofecoxib), the Selective Serotonin Reuptake Inhibitor antidepressants (SSRIs) and salmeterol has been under continuous review by the MHRA since these medicinal products were first authorised. Any new data or possible safety issue to emerge have been carefully evaluated and, as necessary, appropriate action taken to update the product information for prescribers and patients to reflect the emerging safety profile and where necessary revised prescribing advice has been issued.

Vioxx (rofecoxib) was a selective COX-2 inhibitor, a type of non-selective anti-inflammatory drug, licensed for the treatment of osteoarthritis, rheumatoid arthritis and acute pain conditions. In 2000, comparative clinical trial data raised concerns over the risk of heart attacks and other thrombotic cardiovascular events in association with use of rofecoxib. The Committee on Safety of Medicines (CSM, the predecessor to the CHM) reviewed the safety of rofecoxib on several occasions between 2000 and 2003. This led to updates to product information and prescribing advice on the risk of thrombotic cardiovascular events. In 2004, the manufacturers of rofecoxib withdrew the product after clinical trial data comparing rofecoxib with placebo (a dummy pill) provided the first definitive evidence of an increased risk of heart attack and stroke, evident after 18 months of treatment. The safety of other selective COX-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) was fully reviewed between 2004 and 2006 and the conclusion was that the benefits of the authorised NSAIDs continue to outweigh the risks in the licensed indications.

SSRI antidepressants are used to treat depression and anxiety disorders. Ongoing concerns about the safety of the SSRIs in early 2003 prompted a review by an Expert Working Group of the CSM of the risk of suicidal behaviour and withdrawal reactions associated with the SSRIs. The Expert Working Group conducted a comprehensive review of the safety of this entire class of drugs, examining all available evidence and reviewing all the regulatory advice issued. The MHRA published key findings and updated advice to healthcare professionals and patients as the review progressed.

Salmeterol is a long-acting adrenoceptor beta agonist (LABA) used in the management of asthma and chronic obstructive pulmonary disease. The CSM and CHM have reviewed the safety of salmeterol on a number of occasions, leading to updates to product information and communications to remind healthcare professionals of the appropriate use of LABA in the treatment of asthma. The balance of risks and benefits of LABA was recently reviewed at the request of CHM, and was considered positive in the treatment of asthma in adults and adolescents, provided LABA are used with inhaled corticosteroids. The outcome of the review was published in the MHRA bulletin Drug Safety Update, which is available on the MHRA website.

There are currently no complementary or alternative medicines with marketing authorisations for the treatment of major conditions such as osteoarthritis, depression or asthma therefore the MHRA does not hold any information on the usage of complementary and alternative medicines for these conditions.

Some years ago the MHRA considered a number of applications for marketing authorisations for products containing St. John’s Wort (Hypericum perforatum L.) for mild to moderate depression. However, the applications were refused due to lack of adequate evidence of safety and efficacy.