Do Not Use Paroxetine (BRISDELLE) For Treatment of Hot Flashes

The November 2013 issue of Worst Pills, Best Pills News described the imminent marketing of a new treatment for hot flashes associated with menopause, paroxetine (BRISDELLE), which is a lower dose of the antidepressant drug PAXIL. In that article, we discussed medicalizing a normal phase of women’s lives — menopause — for the purpose of selling drugs and promised more information about this drug.

In March 2013, Public Citizen’s Health Research Group testified before a Food and Drug Administration (FDA) advisory committee, speaking out about the drug’s questionable benefits and previously well-established risks, including suicidal thoughts. The advisory committee subsequently opposed approval, but the FDA ultimately overruled this evidence and, in June 2013, approved yet another drug with risks clearly outweighing its benefits. BRISDELLE is now available but is categorized as Do Not Use at WorstPills.org.

About BRISDELLE

BRISDELLE was tested in drug company-funded studies in approximately 1,200 women who experienced seven to eight moderate to severe hot flashes per day for at least 30 days prior to the study. Half the group was randomized to receive the drug, and the other half received a placebo. As of 12 weeks of use, the group receiving a placebo had about a 50 percent reduction in hot flashes (from about 10 per day to fewer than five per day). The group receiving the drug had approximately three hot flashes per day. The reduction in hot flash severity was even smaller: The absolute severity of the hot flashes in the group getting the drug was reduced by less than 2 percent more than the reduction with a placebo.

Although it noted most of these changes to be statistically significant, the advisory committee voted 10 to 4 against there being any clinically meaningful benefit of the drug at 12 weeks.

Meanwhile, the evidence of multiple risks was clear. According to the FDA, adverse reactions that occurred at a notably higher incidence in paroxetine subjects and are plausibly related to the drug include dizziness, nausea, fatigue and mood swings.

It is important to note that women participating in the study had been previously screened and excluded if they had a history of suicidal behavior or ideation (preoccupation with or thoughts of suicide), as well as other psychiatric diagnoses. However, in those women randomized to get BRISDELLE, suicidal ideation, suicide attempt, depressed mood or elevated mood led to drug discontinuation in five paroxetine subjects but none in placebo subjects.

The FDA required a black box warning to be added to the label (see below).

Taking into consideration the lack of any clinically meaningful benefit, along with these proven risks, 10 of the advisory committee members voted against the drug’s approval, with just four voting in its favor.

What You Should Do

BRISDELLE is clearly a Do Not Use drug because it not only lacks evidence of any unique benefit but was not found to have any clinically meaningful benefit. It also causes a variety of well-documented risks.

The article “Hormone Replacement Therapy” in this issue discusses the risks of HRT and also mentions nondrug methods of reducing hot flashes — the kinds of approaches that may explain the relatively high placebo response rate. For women in whom these methods are not effective, we remain committed to our long-standing position that estrogens should be used at the lowest dose and for the shortest duration possible.