Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Menopause Health Center

Font Size

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.
Is it menopause or something else?
senior couple
mature woman shopping for produce
Alcohol Disrupting Your Sleep
mature couple on boat
mature woman tugging on her loose skin
senior woman wearing green hat
estrogen gene

WebMD Special Sections