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Here are two articles about new FDA approvals. First, the FDA has approved a drug to prevent Herpes "shedding." Anyone who might be a candidate for this therapy, please come in to discuss it.
October 1 2003 • Volume 38 • Number 19
Drug Approved for Lowering Herpes Transmission Risk
Valtrex cut transmissions to susceptible partners by 50%-75% in 8-month study.
Valtrex cut transmissions to susceptible partners by 50%-75% in 8-month study.
Elizabeth Mechcatie
The Food and Drug Administration has approved valacyclovir (Valtrex) for use as suppressive therapy to reduce the risk of heterosexual transmission of genital herpes to susceptible partners. Approval was based on the results of a landmark study of more than 1,000 heterosexual, monogamous couples. The study showed that a daily suppressive dose of 500 mg Valtrex taken by the infected partner reduced transmission of symptomatic genital herpes (herpes simplex virus type 2) to the uninfected partner by 75% over 8 months.
The rationale behind using Valtrex to reduce transmission rates is that the drug suppresses recurrences and reduces viral shedding. Dr. Handsfield testified that other options for transmission prevention are only partially effective. These other options are the use of condoms, and awareness of subtle signs and symptoms of genital herpes and abstaining from intercourse when these symptoms are present.
In the trial, 741 participants who had recurrent genital herpes were randomly assigned to receive 500 mg/day of Valtrex; another 743 infected participants were randomized to placebo. Their susceptible partners had no history of genital herpes. At the end of the study, significantly fewer susceptible partners had become infected in the treatment group, compared with the placebo group (0.5% vs. 2.2%, respectively), representing a 75% reduction in risk.
In an interview, Dr. Handsfield said that uninfected partners should be tested to determine whether they have a subclinical infection before their partner starts suppressive treatment. He also emphasized that people given this prescription need to be advised that suppressive therapy is not 100% effective, and that they should still inform their partners that they are infected, be alert for symptoms of breakthrough episodes, and avoid exposing partners when symptoms are present.
Copyright © 2003 by International Medical News Group, an Elsevier company. Click for restrictions.
Second, there is soon to be a new way for you to get your estrogen - The FDA has approved new Estrasorb (estrogen lotion) that you rub into your skin daily. Now, as in Europe, we have four different ways to get estrogen: the pill, the patch, the ring and lotion.
October 21, 2003
Topical Estrogen Wins FDA Approval
NEW YORK (Reuters) Oct 10 - The U.S. Food and Drug Administration on Friday approved Estrasorb, a topical estrogen therapy drug used to treat hot flashes in menopausal women.
The lotion-like drug, which is applied daily, delivers the female hormone estrogen through the skin. King Pharmaceuticals expects to begin marketing the drug in early 2004.
Incidentally, I recently read a statement on estrogen that impressed me, and that I agreed with. It was by Dr. Robert Barbieri of Harvard Medical School. After he considered the latest findings from the WHI research, he said:
(Sept.,2003) "The news about heart disease is much better. In the WHI, the women studied were predominantly healthy and relatively free of cardiovascular disease at the beginning of the study. In the first year of treatment, the risk of coronary heart disease in the women treated with Hormone therapy increased; however, after the first year, the risk of coronary heart disease was similar in the estrogen-progestin and placebo groups.
After 6 years of treatment, there was no difference in the cumulative risk of coronary heart disease between the estrogen-progestin and placebo groups. This means that women who have already completed their first year of estrogen-progestin treatment are unlikely to be at additional increased risk for coronary heart disease based on estrogen-progestin treatment."
So if you have been on hormones for over a year, you probably have no increased risk of heart disease from continuing it. Dr. Rehert
The above is not meant to be medical advice. Please read the attached Disclaimer, Etc.
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Best wishes. Dr. Rehert
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