Clipping of news on Brazilian Culture, Law and Citizenship
07/01/2013
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Treatment is the first not to use hormones in their formula
RIO - The FDA, the U.S. agency that regulates food and drugs, approved last Friday the first non-hormonal drug against hot flashes of menopause. The drug, called Brisdelle is made with a low dose of paroxetine also used (at higher doses) the antidepressant Paxil.
The drug offers a new alternative for women with menopause. Until then, treatment was usually done with estrogen, sometimes combined with progesterone. However, the use of these hormones has fallen since 2002, when a study suggested that they could increase the risk of cardiovascular problems and cancer.
The FDA's decision, however, surprised experts. An advisory committee of the agency met in March and by 10 votes to 4, this treatment is not recommended. The approval of a drug that has received a strong negative opinion is quite unusual.
The agency did not explain the reasons why contradicted the recommendation of the experts advice. And claimed that Brisdelle was considered a useful treatment goals with results recorded during their tests.
The drug should be distributed in the U.S. market starting in November. Its price has not been disclosed by the pharmaceutical company Noven. His label has some caveats, such as the possibility of the drug increase suicidal thoughts (message like the leaflets of other drugs containing paroxetine). The increased risk of bleeding must also be included among the possible side effects.
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Source: The Globe - Online
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This article was translated by an automatic translation system, and was therefore not reviewed by people.