May 25 Pharmacy Week in Review: FDA Issues Approvals for 2 Drugs, and a Safety Alert for HIV Medication

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Nicole Grassano, Host: Hello, and welcome to the Pharmacy Times News Network. I’m Nicole Grassano, your host for our Pharmacy Week in Review.

The FDA has approved avatrombopag (Doptelet, AkaRx) tablets to treat low blood platelet count in adults with chronic liver disease (CLD) who are scheduled to undergo a dental or medical procedure, the first drug approved for this use by the agency, Pharmacy Times reported. Patients with CLD who have low platelet counts—thrombocytopenia—and who require a medical or dental procedure are at increased risk of bleeding, according to the FDA.

Doptelet was demonstrated to safely increase the platelet count. The drug may decrease or eliminate the need for platelet transfusions, which are associated with the risk of infection and other adverse reactions, according to the FDA. The drug is expected to be available in June, according to Dova Pharmaceuticals, the parent company of AkaRx.

The FDA and the European Medicines Agency issued safety alerts for the HIV medication dolutegravir, after serious cases of neural tube birth defects, including spina bifida, were reported, according to Contemporary Clinic. The affected babies were born to women with the HIV virus, who had been treated with the drug.

According to an ongoing observational study in Botswana, women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for birth defects involving the brain, spinal cord, and spine. The study has looked at babies born to 11,558 women with HIV in Botswana. The study’s current data suggest that 0.9% of these babies whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies whose mothers were taking other HIV medications.

FDA officials have approved the use of denosumab (Prolia, Amgen) to treat glucocorticoid-induced osteoporosis, Specialty Pharmacy Times reported. The treatment is indicated for adults at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available therapies.

The approval is based on data from a 12-month analysis of a 24-month phase 3 trial evaluating the safety and efficacy of denosumab. According to the findings, patients on glucocorticoid therapy who received denosumab had greater gains in bone mineral density than those who received active comparator risedronate.

Pharmacists may get more questions about Xeljanz XR if their patients have seen a new commercial for the prescription medication to treat rheumatoid arthritis (RA). In the spot, called 'Biking,' after a woman with RA takes Xeljanz XR, her pain no longer distracts her, and she is able to help her daughter learn to ride a bike. According to the commercial, the daily pill can reduce pain and swelling and has the potential to stop further joint damage.

For more great coverage and practical information for today’s pharmacist, visit our website and sign up for our Daily eNews. And don’t forget to follow us on Facebook, Twitter, and Instagram. Thanks for watching our Pharmacy Week in Review. I’m Nicole Grassano at the Pharmacy Times News Network.