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FDA rejects new diet drug Qnexa

[ABC News, July 16, 2010] The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 10-6 against recommending new diet drug Qnexa, noting that there is a lack of data about the drug’s cardiovascular effects.

An earlier review of Qnexa seemed to indicate that the drug was highly effective as some participants in clinical trials of the drug lost as much as 10 percent of their starting body weight. However, the trials also showed an increased risk of psychiatric and cognitive issues, as well as the potential to cause birth defects in the children of women who became pregnant while using Qnexa.

Qnexa is the first of three new weight loss drugs to go before the FDA this year, seeking approval. The other two, Lorcaserin and Contrave will be reviewed by the FDA later this year.

Although the panel voted against recommending Qnexa, the FDA as a whole is not bound by the panel’s recommendation. Eric Coleman, deputy director of the FDA division that provides oversight for metabolic drugs, expressed surprise at the panel decision. He noted that many members of the panel were not strongly opposed to Qnexa but simply had reservations about it.

Read the full story at ABC News.


 

 

 
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