Two “Hot Flash” Drugs Rejected by FDA

An FDA panel recently voted against approving two drugs put forth as being non-hormonal treatments for hot flashes during menopause. Currently, there are no FDA-approved non-hormone medications for menopausal hot flashes. Women have been seeking ways to decrease hot flashes without using drugs which employ hormones. According to WebMD, hot flashes occur in about two-thirds of women going through menopause in the U.S. but the precise cause is not known. In some cases, doctors have prescribed antidepressants with dangerous side effects even though the drugs are not labeled for use in preventing hot flashes (a practice known as "off-label prescribing"). One of the drugs, "Sefelsa", was rejected by a 12-2 vote. A member of the panel, Valerie Montgomery Rice, MD of the Morehouse School of Medicine in Atlanta, explained why she voted against approving the drug by stating, "As much as I would love to have non-hormonal alternatives for women, I'm concerned about the sustainability and the limited [effectiveness] of this product. I'm also concerned about the dizziness and disorientation with this drug." Another panel member voiced concerns regarding the possible side effects of the drug to mental health and the central nervous system. If you were harmed after taking legally prescribed drugs then consult with a medical malpractice attorney as soon as possible.

The second drug that was up for consideration by the FDA panel is a low-dose version of the already available antidepressant "Pexeva". This drug was rejected as an anti-hot flash drug in a 10-4 vote. MD Julia Johnson discussed the reason for her vote saying that "…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."

Do you have a medical malpractice case involving medications?

Prescription drugs have been linked to an overwhelming number of injuries, cases of dangerously erratic behavior, suicides, heart attacks, strokes and others. If you or someone you care about was harmed after taking medication according to the doctor's directions, or if a loved one committed suicide while on prescription drugs then you may have a medical malpractice case. A skilled and compassionate lawyer with us at the Tolson Law Firm has successfully represented clients in cases which resulted in multi-million dollar settlements. You deserve compensation for your injuries and losses after putting your health and your very life in the hands of a medical professional who acted negligently. Contact our law offices today to schedule a free case evaluation.