NPC Archive Item: April Drug Safety Update from MHRA/CHM

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The MHRA and CHM have published the latest issue of Drug Safety Update (7th April 2008)

Drug Safety Update highlights the following points:

  • Oral contraceptives and cervical cancer: Further evidence suggests that long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer. The level of risk returns to that for never-users within 10 years of stopping use (see separate blog).

  • Combined hormonal contraceptives and venous thromboembolism: The risk of venous thromboembolism in users of Yasmin® is in the same range as that for users of combined oral contraceptives that have low ethinylestradiol dose, including second-generation pills. The risk in users of the Evra®contraceptive patch may be slightly increased compared with that for users of second-generation pills. You may find helpful related information on the NPCi floors which deal with contraception and venous thromboembolism.

  • Cyproterone acetate with ethinylestradiol (co-cyprindiol; products include Dianette®) – recommended duration of use: Co-cyprindiol is licensed as a second-line treatment for women with severe acne or moderately severe hirsutism. Most women will be able to stop co-cyprindiol three to four months after resolution of symptoms. This should not be interpreted as stopping treatment after 3–4 months. For women with known hyperandrogenism who attend specialist clinics, co-cyprindiol may be the only effective treatment for severe symptoms. Under these circumstances, co-cyprindiol can be prescribed in the longer-term with regular specialist review.

  • Carbamazepine: genetic testing recommended in some Asian populations: The risk of carbamazepine-induced Stevens-Johnson syndrome is strongly associated with presence of the HLA-B*1502 allele in individuals of Han Chinese, Hong Kong Chinese, or Thai origin. It is recommended that these individuals should be screened for HLA-B*1502 before prescription of carbamazepine. Those who test positive should not start carbamazepine unless the benefits clearly outweigh the risks of Stevens-Johnson syndrome.

Drug Safety Update also highlights the recent introduction of the Traditional Herbal Registration (THR) scheme. The first products registered in the UK under this scheme are now coming onto the market. Registered products have been assessed by the MHRA and meet systematic standards of safety, quality, and patient information, but indications are based on traditional use rather than proven efficacy. Registered products are suitable for use without medical supervision. Herbal medicines with a Marketing Authorisation also continue to be available.

There is also information about use of over the counter cough and cold medicines for children (see also our previous blog); the risk of severe reactions (including liver failure) following accidental overdose of clove oil in children (less than 5 ml in some reports); suicidal thoughts and behaviour with antidepressants and the risk of ovarian cancer with combined oral contraceptives

Notes about Drug Safety Update

Drug Safety Update is an essential read for everyone whose professional practice involves medicines.

Drug Safety Update replaces Current Problems in Pharmacovigilance, the last issue of which was produced in May 2006. Drug Safety Update is published every month. A copy of Current Problems used to be sent to all doctors, dentists, pharmacists and coroners in the United Kingdom but paper copies of Drug Safety Update will not be posted to any group of clinicians.

If you would like to receive an e-mail notification when new issues of ‘Drug Safety Update’ are published, please subscribe to the MHRA’s free e-mail alerting service.


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