The Future

| Home | | Pharmacovigilance |

Chapter: Pharmacovigilance: Pharmacoepidemiology of Hormone Therapy: An Evolving Picture

There is no doubt that future drugs being developed for postmenopausal prevention and treatment of disease will be undergoing intense scrutiny by the FDA, the medical community and consumers.


THE FUTURE

There is no doubt that future drugs being developed for postmenopausal prevention and treatment of disease will be undergoing intense scrutiny by the FDA, the medical community and consumers. Each of these groups is better informed now than in the mid-1990s, and as new replacements for oestrogen therapy (such as new oestrogen receptor modulators or SERMS) are explored, the lessons of HT will remain in the forefront, influencing the way future drugs are developed, approved, marketed and prescribed.

Several professional societies have weighed in on these issues (and continue to do so). The American College of Obstetricians and Gynecologists (ACOG), for example, formed a task force to examine the evidence from WHI and other studies and in 2004 issued the following statement: ‘The risks of HT exceed the benefits for the prevention of chronic diseases in postmenopausal women. Hormone ther-apy remains an effective therapy for treating women with vasomotor symptoms and vaginal atrophy.’ The ACOG task force went on to state that

The use of HT for specific indications, for exam-ple, treatment of menopausal symptoms or treatment of osteoporosis, will require balancing the known benefits of HT in treating these conditions with the known or potential risks of HT, as well as balancing the benefits and risks of alternatives to HT. Clearly, healthy symptomatic women who choose to use the most effective treatment for menopausal symptoms, that is, HT, should not be denied this option based on available data regarding health risks (ACOG, 2004).

The EMAS has also carefully weighed the risk/benefit ratio of HT and has revised their earlier recommendation statements for clinical practitioners regarding peri- and postmenopausal HT to reflect the changing state of research following WHI (EMAS 2005; Neves-e-Castro et al., 2002).

As noted by the ACOG HT Task Force (2004) and by others, ‘Virtually all medications carry risks as well as benefits, and as detailed in the preceding chapters, HT is no exception. Balancing these beneficial and harmful effects is a challenging but important task for making informed decisions about the prescribing and use of HT.’ Despite the many questions answered by WHI and the even more questions raised by this study, it is clear that professional societies in both Europe and the US feel that there is no one solution for all postmenopausal women. It is also true that one piece of clarity in all of this controversy is that the WHI has paved the way for more open communication between the postmenopausal women and her health care provider. That is most certainly a good thing.

Contact Us, Privacy Policy, Terms and Compliant, DMCA Policy and Compliant

TH 2019 - 2022 pharmacy180.com; Developed by Therithal info.