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The Pharmaceutical Journal Vol 264 No 7082 p204
February 5, 2000 Clinical

Emergency contraceptive could be available OTC within the year

Schering Health Care launched its progestogen-only form of emergency contraception, Levonelle-2, on February 2 (see p231). Levonelle-2, which has been licensed as a prescription only medicine (POM), has fewer contraindications and side effects than the only other UK licensed oral emergency contraception (Schering PC4) and could be made available through pharmacies within the year, the company says.
Speaking at a press briefing on February 2, Dr Peter Longthorne (medical director, Schering Health Care) told The Journal that Schering supported the move from a POM to pharmacy-only licence for Levonelle-2 and said that he hoped to see it happen later this year. Ms Toni Belfield (director of information, Family Planning Association) added that the FPA welcomed the commitment to a move for Levonelle-2 from POM to P status but realised that support must be given to pharmacists to help with the transition.
The launch of Levonelle-2 follows a World Health Organisation trial in nearly 2,000 women that showed the progestogen-only regimen (two doses of 750µg levonorgestrel taken 12 hours apart) prevented 85 per cent of expected pregnancies when treatment was initiated within 72 hours of unprotected sex, compared with 57 per cent with Schering PC4 (two doses of 500µg levonorgestrel and 100µg ethinyloestradiol taken 12 hours apart) (Lancet 1998;352:428). The trial also showed that there was significantly less nausea and vomiting with levonorgestrel alone than with the combined method.
Dr Diana Mansour (consultant in community gynaecology and reproductive health care at Newcastle general hospital), speaking at the launch, said: "We can now offer women a more reliable emergency contraceptive that causes less nausea and vomiting".
Dr Rosemary Leonard (general practitioner, London) said that GPs would have no good reason to continue prescribing PC4 now that a more effective and better tolerated product was on the market. Dr Longthorne added that PC4 would continue to be marketed but he foresaw that it would eventually be phased out.
The 1998 WHO trial also confirmed earlier suggestions that efficacy of hormonal emergency contraception is greater the earlier it is given. For the progestogen-only regimen, 95 per cent of expected pregnancies were prevented when treatment was initiated within 24 hours and 58 per cent when treatment was initiated between 49 and 72 hours (Lancet 1999;353:721). A similar profile in efficacy reduction was seen with the combined method.
Mr Roger Odd (head of professional and scientific support, Royal Pharmaceutical Society of Great Britain), commenting at the launch, said that the Society was keen to work with Schering and the various professional groups to make emergency contraception more accessible to the public and supported its move from POM to P status.