Intrarosa Side Effects: Discharge and Abnormal Pap Smear




Intrarosa Side Effects? What are the side effects of Intrarosa? According to the Food and Drug Administration (FDA) which recently approved Intrarosa for use by post-menopausal women who experience moderate to severe pain during sexual intercourse, the most common side effects of the drug are vaginal discharge and abnormal pap smear.

intrarosa side effects - vaginal discharge and abnormal pap smear

In four clinical trials which had a total of 665 post-menopausal women participants who used Intrarosa, a total of 38 cases — or 5.71% — report having vaginal discharge. This is higher than the incidence reported for the placebo treatment group — 3.66% or 17 cases in 464 participants.

A separate trial confirms vaginal discharge among the side effects or adverse reactions to Intrarosa. In fact, the incidence is much higher at 14.2% (74 cases out of 521 participants). In addition, abnormal pap smear were also reported by 11 participants or 2.1% of those who participated in the trial.

Here are details of the studies which looked into possible Intrarosa side effects:

In four (4) placebo-controlled, 12-week clinical trials [91% -White Caucasian non-Hispanic women, 7% Black or African American women, and 2% -“Other” women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group.

In a 52-week non-comparative clinical trial [92% -White Caucasian non-Hispanic women, 6% Black or African American women, and 2% -“Other” women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent. There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS).

It is worth pointing out that vaginal discharge and abnormal pap smear are not all of the Intrarosa side effects. You may experience other side effects apart from these two.

At any rate, do report any side effects to your doctor. You might also want to contact the FDA at their number 1-800-FDA-1088.

FEMALE HEALTH DRUGS:
Essure Side Effects



Intrarosa Side Effects: Vaginal Discharge and Abnormal Pap Smear posted 24 December 2016. Latest update on 24 December 2016.