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Kathryn Wheeler, PharmD, BCPS
Kathryn Wheeler, PharmD, BCPS, is assistant clinical professor of pharmacy practice, University of Connecticut School of Pharmacy, Storrs, Conn.
Flibanserin: Risk potential vs. possible benefit
Because of concerns about adverse effects, training through the Addyi REMS program is required for prescribers and pharmacies that want to participate in the medication use process for this drug.
FDA approves new Pradaxa reversal agent
Patients taking Pradaxa had no option for anticoagulation reversal; it was this unmet medical need that caused FDA to grant idarucizumab accelerated approval.
New first-in-class drug therapy for heart failure
In April 2015, FDA approved Ivabradine to reduce the risk of hospitalizations due to worsening heart failure in indicated patients.
Riociguat, first drug of new class, available for PAH
Approved in October 2013 for two patient groups, Riociguat (Adempas, Bayer) is a first-in-class sGC stimulator.
FDA approves new once-daily treatment option for HIV
Dolutegravir, a new, once-daily option, may allow improved personalization of a patient’s medication regimen.
New molecular entity: Tivicay
An integrase strand transfer inhibitor for treatment of HIV 1 infection in adults and pediatric patients aged 12 years and older and weighing at least 40 kilograms, as part of combination antiretroviral therapy.
New SERM approved for dyspareunia
An estrogen receptor agonist, ospemifene counteracts the effects of declining estrogen hormones on vaginal tissue, thereby reducing pain during intercourse.
New molecular entity
On February 26, 2013, FDA approved ospemifene (Osphena, Shionogi Inc.) for the treatment of moderate-to-severe dyspareunia resulting from vulvar and vaginal atrophy associated with menopause. Estrogen levels decline during menopause, resulting in a thinning and drying of vaginal tissues. This atrophy can cause a woman to experience pain during intercourse (dyspareunia).
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