A drug designed to boost women’s sex drive received its FDA approval Tuesday, making it the first such medication approved by the agency. But controversy continues to swirl around Sprout Pharmaceuticals’ Addyi (flibanserin) because of side effects, which include serious risks of low blood pressure and fainting. Doctors and pharmacists will need to be specially certified to deal with the new drug because of such side effects, which also include nausea and drowsiness. Some question whether the supposed condition the new medication is designed to treat, known as hypoactive sexual desire disorder, actually exists at all, reported The Wall Street Journal.
The rising number of Americans with health insurance to cover their prescription drug costs is having a negative impact on the bottom line at Walmart pharmacies, which are reporting fewer high-margin cash transactions in the past quarter, the retail giant said when it released its second-quarter earnings. Pharmacy benefit managers are cutting reimbursement rates, which is also impacting pharmacy performance, Walmart said. “We expect to have pressure on pharmacy for the rest of the fiscal year,” said Greg Foran, president and CEO of Walmart US.
Mylan, which is attempting a takeover of Perrigo, received a warning letter from the FDA about “significant violations” of manufacturing-quality rules in three of its plants in India, Bloomberg Business reported. Mylan has been critical of generic drug quality from Indian drugmakers and backed tougher US regulation of them.
The first defendant in a case involving online sales of $78 million worth of counterfeit and mislabeled drugs was arraigned, the Justice Department announced. Among the entities indicted are CanadaDrugs.com and one individual, Ram Kamath, who is charged with allegedly illegally storing counterfeit Avastin in his garage.
An investigational implantable pump outperformed Merck’s Januvia in a year-long Phase-III study involving 535 patients with Type 2 diabetes, Intarcia Therapeutics, the developer of the pump, announced. The pump, ITCA 650, holds a year’s supply of the diabetes drug exenatide and is implanted in abdominal tissue. The trial found that patients with the implant had a 1.5% reduction in a blood-sugar measure known as HbA1C, compared to 0.8% for patients taking a 100 mg dose of Januvia daily. Patients using the pump also had greater weight reduction in patients compared to patients treated with Januvia.
CORRECTION: An earlier version of this story incorrectly listed PharmacyChecker.com as a defendant. PharmacyChecker.com is not a defendant in the case. Ram Kalath is a former consultant for PharmacyChecker.com. We apologize for the error.