Hot Flash from FDA Advisors

Hot Flash from FDA Advisors
Hot Flash from FDA Advisors

Is it hot in here or is it me? That’s the not-so-funny punch line of menopause. 75% of the 32 million women experiencing menopause each year suffer from hot flashes. Hormone replacement therapy (HRT) offered relief for hot flashes and the full spectrum of menopause symptoms, but they have high risks.

Reuters reported that two companies were in test for the first non-hormonal drugs that reduce the frequency and severity of hot flashes, but in early March 2013, an advisory panel of the FDA voted against approving them. The FDA determined that neither offered enough benefits to offset the risks. The 2 companies were Hisamitsu Pharmaceutical Co Inc’s subsidiary Noven Pharmaceuticals Inc. and Depomed Inc.

Depomed’s drug Sefelsa is a long-acting version of the epilepsy drug gabapentin. In clinical it was not only ineffective but came along with a handful of side effects that were nearly as bad as the hot flashes. It also increased the risk of suicide.

Noven’s drug was a low dose antidepressant similar to Paxil. In its trials it’s efficacy was unclear because many of those taking placebos improved also.

Sadly for the Flash Brigade (which I was finally released from myself a year or two ago), we don’t have a non-hormonal drug solution for hot flashes yet.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.
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