Skip to content

    Menopause Health Center

    Font Size
    A
    A
    A

    FDA Panel Nixes 2 Nonhormonal Meds for Hot Flashes

    Low-Dose Pexeva

    Later in the day, the panel voted 10-4 against low-dose Pexeva, saying the drug's minimal benefit did not outweigh its risks.

    A few concerns also were raised about the drug's safety profile, and in particular its association with suicidal thoughts and osteoporosis.

    Julia V. Johnson, MD, from the University of Massachusetts Medical School in Worcester, who was chairperson of the day's committee meeting, says she felt those risks were small and did not appear to be different from the risks seen with more standard doses of paroxetine. "Still, we have very little information about this lower dose. We did see some effect on suicidal ideation, and I was somewhat concerned that there may be a greater effect than seen."

    A bigger stumbling block for the panel was the relatively small benefit seen with Pexeva compared with a placebo. "I voted against recommending approval when I looked at the magnitude of the treatment effect relative to the magnitude of the placebo effect, where there is no risk involved," says Daniel L. Gillen, PhD, from the University of California, Irvine.

    However, some panel members believe they saw some evidence of benefit with the drug.

    "I'm not worried about the safety profile, because it's already an FDA-approved drug. If we are worried, the way to address that is to help women access a lower-dose version," says Eleanor Bimla Schwarz, MD, from the University of Pittsburgh School of Medicine in Pennsylvania.

    Richard Bockman, MD, PhD, from the Hospital for Special Surgery in New York City, says it is time to approve this drug because it is already being commonly used off-label to treat hot flashes.

    "I think there is a very small beneficial effect from this drug," he says, explaining his yes vote. "It is widely used and there is wide experience with this drug. This very small dose is probably safe. I think it's time to legitimize its use."

    Clifford J. Rosen, MD, from Maine Medical Center Research Institute in Scarborough, voted against recommending approval but says he empathizes with the yes voters.

    "In some ways, having an indication might allow us to have better surveillance over who is getting this drug and how it is being utilized. Right now, we have very strong difficulty figuring this out," he says.

    Today on WebMD

    woman walking outdoors
    How to handle headaches, night sweats, and more.
    mature woman holding fan in face
    Symptoms and treatments.
     
    woman hiding face behind hands
    11 ways to keep skin bright and healthy.
    insomnia
    Is it menopause or something else?
     
    senior couple
    Video
    mature woman shopping for produce
    Article
     
    Alcohol Disrupting Your Sleep
    Article
    mature couple on boat
    Article
     
    mature woman tugging on her loose skin
    Slideshow
    senior woman wearing green hat
    Article
     
    estrogen gene
    Quiz
    supplements
    Article
     

    WebMD Special Sections