- Novo Nordisk position statement4 December 2003 On 3 December 2003, The European Agency for the Evaluation of Medicinal Products (EMEA) informed healthcare companies marketing hormone replacement products of their decision to restrict the indication for osteoporosis to secondary prevention. Hormone replacement therapy (HRT) is primarily indicated for women who suffer from menopausal symptoms, such as hot flushes and night sweats. As acknowledged by the expert panel established by EMEA and authorities, the benefit-risk balance is considered acceptable for HRT when used for the treatment of women suffering menopausal symptoms. Novo Nordisk supports the healthcare authorities’ recommendation that the lowest effective dose should be used and the treatment should be continued as long as the benefit in alleviation of severe symptoms outweighs the individual risk. Novo Nordisk will comply with the recommendation from EMEA to restrict the indication for osteoporosis prevention as a second-line therapeutic option and will adjust prescribing information accordingly. HRT is proven effective in preventing loss of bone and increasing bone mineral density (BMD). In addition the Women’s Health Initiative (WHI) demonstrated that HRT prevented fractures in women with or without clinical risk factors for osteoporosis. Therefore, for women taking hormone therapy for menopausal symptom relief there is an additional benefit of bone protection. HRT may remain a treatment option for women who are at an increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatment or in cases where other therapies prove to be ineffective. In conclusion, Novo Nordisk believes that osteoporosis prevention is a secondary benefit of hormone therapy besides the primary indication for relief of menopausal symptoms. Each decision to start or stay on HRT should be made on an individual basis, and treatment should be regularly reappraised (at least once a year). Women, who wish to stop HRT, or change their current preparation, should make a routine appointment to discuss their treatment options with their doctor. | 
