Brisdelle was recently approved by the FDA for treatment of hot flashes due to menopause due to natural or surgical causes. Paroxetine has been used for hot flashes off-label (without FDA approval) for a number of years. The main change with Brisdelle is that it is offers a lower dosage of paroxetine than has been available previously.
The major advantages of Brisdelle over conventional therapy (hormone therapy) are the following:
1) It does not increase the risk of breast cancer.
2) It does not increase the risk of blood clots.
3) It is available in a lower dose than paroxetine used for other conditions, so the side effects could be less severe than the side effects when the higher doses are used.
4) It is a mild antidepressant. Paroxetine has been used for many years as an antidepressant. However, in the low dose found in Brisdelle, it may not help depression. Although Brisdelle interacts with many antidepressants, it is still possible to take Brisdelle with other antidepressants as long as you do not have side effects. You should make your doctor aware that you are taking Brisdelle, especially if you develop side effects.
5) It may make you drowsy. About 10 women in clinical trials needed to be treated with Brisdelle versus placebo for one to note lethargy, malaise or fatigue as a side effect. If it does cause this side effect for you, take it at bedtime and you may enjoy better sleep than you did before menopause.
The disadvantages of Brisdelle versus hormone therapy include the following:
1) It not as effective as hormone therapy. The clinical trial numbers showed that one would have to treat about 8 patients with Brisdelle for one to get a 50% reduction in symptoms. There hasn’t been any trial yet directly comparing paroxetine with hormone therapy, but it has been known for years that hormonal therapy is highly effective.
2) It may lower blood levels of tamoxifen. A major group of patients who might consider Brisdelle are breast cancer survivors. Many breast cancer survivors take tamoxifen to prevent recurrence. However, Brisdelle might lower the effectiveness of tamoxifen in this group.
3) It has multiple drug interactions. These interactions include commonly used medications such as respiridone (Risperdal), cimetidine (Tagamet, available over the counter in many generic forms), desipramine, and digoxin.
Of particular interest to patients with a history of blood clots is that Brisdelle could potentially increase the levels of warfarin (Coumadin) in the blood. It is very important to have your INR monitored carefully if you take both warfarin and Brisdelle.
4) It can increase the risk of bleeding independent of the use of anticlotting medications. The risk of major bleeding is very small. For patients who also take medications that interfere with blood clotting, such as aspirin, ibuprofen, naproxen, clopidogrel, and warfarin, Brisdelle may add to bleeding risk.
5) It can change salt levels in the blood. The medication hasn’t been studied well in patients over the age of 65, although it is approved for use in this age group. Uncommonly, older patients who take medications in the same class as Brisdelle have had a problem with low levels of sodium in the blood. Regular blood testing can keep this problem from becoming serious.
If Brisdelle is not right for you, there are other alternatives. Depending on your risk profile, your doctor may consider prescribing venlafaxine, desvenlafaxine, paroxetine (regular dose), or gabapentin. None of these therapies are FDA approved for hot flashes, but have been used for several years off label.
Brisdelle [package insert].Noven Therapeutics, LLC, Miami, FL; June 2013. https://www.brisdelle.com/pdf/PI_MedGuide.pdf. Accessed August 21, 2013.
Carroll, Dana G. “Nonhormonal Therapies for Hot Flashes in Menopause.” – American Family Physician. American Academy of Family Practice, 1 Feb. 2006. Web. 22 Aug. 2013.