Biotech Values

[genisi]

Qnexa slightly affects the level of estrogen I am not sure if its the reason for pregnancy.

Weight loss may increase fertility.

What will be an effective pregnancy prevention plan?

This is what the panel recommended on that:
"In summary, the MHT has the following recommendations for Qnexa:
1. Classify Qnexa as Pregnancy Category X - There are potential fetal risks and no acceptable clinical benefits for a woman using Qnexa in pregnancy.
2. Require that the Qnexa Risk Evaluation Mitigation and Strategy (REMS) have a goal for pregnancy prevention. Pregnancy prevention and related recommendations should be placed in labeling, including the Medication Guide for patients. The Sponsor should provide recommendations for effective contraception use during Qnexa therapy."