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Volume 488: debated on Wednesday 25 February 2009

To ask the Secretary of State for Health what research his Department (a) has undertaken, (b) plans to undertake and (c) has evaluated on (i) the side-effects of (A) Vioxx, (B) SSRI antidepressants and (C) Salmeterol and (ii) the use of complementary and alternative medicines to treat the conditions such drugs were developed to address; and if he will make a statement. (256529)

As with all medicines authorised in the United Kingdom, the safety of Vioxx (a selective COX-2 inhibitor for the treatment of arthritic conditions and acute pain), the selective serotonin re-uptake inhibitor (SSRI) antidepressants and salmeterol (a long-acting adrenoceptor beta agonist, or LABA, used in the management of asthma and chronic obstructive pulmonary disease) are kept under close and continuous scrutiny by the Medicines and Healthcare products Regulatory Agency (MHRA) using a wide variety of data sources. These include spontaneous adverse drug data from the UK and worldwide, clinical trials and epidemiological studies, worldwide published medical literature, data from the manufacturer and information from worldwide regulatory authorities.

If a new safety issue is identified, the MHRA thoroughly evaluates all relevant data with input from UK and European Expert Advisory Committees, as necessary. Action is taken where appropriate to minimise risk to patients, optimise safe use and issue updated prescribing advice.

Vioxx (rofecoxib) was voluntarily withdrawn by the manufacturers in 2004 when the risk of thrombotic cardiovascular events became apparent. Although no formal research was undertaken directly by the Department, all available safety information was continuously evaluated by the MHRA as it emerged. Throughout these reviews, additional data and analyses were requested from the company where necessary to facilitate thorough assessment. Product information for prescribers and patients was updated during the course of these reviews, in line with expert advice.

In response to public concern, in May 2003, an Expert Working Group was established to conduct a comprehensive evaluation of the available data relating to the safety of SSRI antidepressants, in particular, the risk of suicidal behaviour and withdrawal reactions. The Expert Group considered the findings of laboratory, clinical and observational studies along with information relating to reports of patient experiences. In relation to the risk of suicidal behaviour, the MHRA conducted a study using the UK General Practice Research Database (GPRD). Full information on the data considered as part of this review has been published in the group’s report which is available on the MHRA’s website at:

A copy has been placed in the Library.

Since completion of this review, every effort has been made by the MHRA to evaluate new data as they have arisen and issue updated prescribing advice as appropriate. This has included updated advice regarding safety of use of paroxetine in pregnancy following findings from new international studies that certain birth defects are more common in babies whose mothers took paroxetine early in pregnancy. Further advice has also been issued regarding the risk of suicidal behaviour to reflect the findings of review of data from clinical trials conducted by the US Food and Drug Administration.

The MHRA has evaluated the risk of side effects associated with use of salmeterol on a number of occasions, leading to updates to product information and communications to remind health care professionals of the appropriate use of LABAs in the treatment of asthma. The balance of risks and benefits of LABAs was recently reviewed and considered to be favourable in the treatment of asthma in adults and adolescents, provided they are used with inhaled corticosteroids.

The MHRA have not received any applications for marketing authorisations for complementary or alternative medicines for the treatment of major conditions such as osteoarthritis or asthma, therefore the MHRA has not undertaken or evaluated any research in this area. The MHRA do not have any specific plans to undertake such research but would assess all data associated with any application, should one be received in the future.

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. The data submitted by the companies intending to market the products, including any UK and international research, were thoroughly reviewed. However, the applications were refused due to lack of adequate evidence of safety and efficacy.