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March 4, 2013

No Hot Flash Relief Here: Medications for Depression, Seizures and Neuropathic Pain Should Not Get Nod From the FDA

Trials Showed Minimal to No Meaningful Benefits From Taking Paroxetine or Gabapentin to Relieve Menopause-Related Symptoms

WASHINGTON, D.C. – A drug approved to treat depression and other mental health disorders and another designed to prevent seizures and treat postherpetic neurolgia (a painful condition due to nerve injury following a shingles infection) should not be approved to relieve hot flashes because they don’t work and cause dangerous side effects, Public Citizen told the U.S. Food and Drug Administration (FDA) today.

Testifying before the FDA’s Advisory Committee on Reproductive Health Drugs, Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, urged the FDA not to approve the anti-depressant paroxetine and the anti-seizure/neuropathic pain medication gabapentin to treat vasomotor symptoms – hot flashes and flushing caused by menopause.

There is insufficient evidence that the drugs provide clinically meaningful benefits, Carome said. In addition, paroxetine is a psychotropic drug with many well-documented risks. Side effects include seizures, manic episodes, low blood sodium levels, insomnia, agitation, tremor, dizziness and loss of interest in sex. Patients can experience withdrawal symptoms upon stopping the drug. Data from the clinical trials in menopausal women also suggests paroxetine may cause suicidal thoughts.

Similarly, side effects associated with gabapentin include suicidal tendencies, dizziness, sleepiness and nausea.

“As severely unpleasant as hot flashes can be, they are not life-threatening. These medications, however, can cause serious, even fatal, side effects,” Carome said. “Not only won’t they accomplish what they are supposed to, but they likely will do a lot of damage instead, given the large number of women who experience hot flashes.”

The proposed brand name for gabapentin, if approved for hot flashes, is Sefelsa.This version of gabapentin would be manufactured by Depomed. Paroxetine for hot flashes, would be made by Noven Pharmaceuticals.

To read Carome’s testimony on paroxetine, visit www.citizen.org/hrg2100.

To read Carome’s testimony on gabapentin, visit www.citizen.org/hrg2099.

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