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Weekly Drug News Round-Up: May 4, 2016

First-Time Generic Approved for Crestor

Just one year ago, Crestor was the top prescribed brand name drug in the U.S. Read More...

High cholesterol, high low-density lipoprotein (LDL) or “bad cholesterol”, and triglycerides increase the risk for serious heart disease and may lead to heart attacks and strokes. The FDA has now approved the first generic version for Crestor, known by the generic name of rosuvastatin. Rosuvastatin was approved for three uses: high triglycerides in addition to diet; primary dysbetalipoproteinemia (improper breakdown of cholesterol and triglycerides) in addition to diet; and alone or with other cholesterol treatments for adult homozygous familial hypercholesterolemia, (high LDL cholesterol). Common side effects include headache, muscle pain, stomach pain, weakness, and nausea.

Nuplazid is First Drug Available for Parkinson’s Disease Psychosis

Nuplazid shows no measurable activity at dopaminergic receptors

The FDA has approved Acadia’s once-daily Nuplazid (pimavanserin) tablets, the first atypical antipsychotic to treat hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Nuplazid exhibits inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors. In a six-week study of 199 patients, Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease. Common side effects include: swelling (peripheral edema), nausea, and confusion. Nuplazid can also lead to QT interval prolongation.

AstraZeneca’s Bevespi Aerosphere Wins Approval for COPD

There were no unexpected safety findings; however, common side effects included cough Read More...

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long-acting, fixed dose beta2-adrenergic agonist (LABA) and anticholinergic combination approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere is used twice a day via a pressurized metered dose inhaler (pMDI). In studies, Bevespi Aerosphere achieved lung function endpoints (significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks) compared to it’s individual agents and placebo.

FDA MedWatch: Aripiprazole Linked With Impulse Control Concerns

Although previously reported, these impulse control disorders do not fully reflect the label Read More...

Aripiprazole is an antipsychotic medication used in mental health disorders such as schizophrenia and bipolar depression. Yesterday, the FDA warned that rare, uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). The urges stopped when the drug was discontinued or the dose was reduced; however, patients should not stop taking the drug without speaking to their doctor first. The FDA will be updating all aripiprazole product labels with this expanded information. Health care providers should inform patients and caregivers of these uncontrollable, possibly harmful urges, and patients should be closely monitored.

Brintellix Gets a New Name Due to Brand Name Confusion

During the transition, prescribers should write both brand and generic name and the indication to help avoid confusion Read More...

The drug names Brintellix and Brilinta look similar and it’s easy to see how they could be confused in the clinic or pharmacy. In fact, these names were previously reported as being mixed up in 2015 by the FDA. But these drugs are very different - Brintellix (vortioxetine) is an antidepressant, and Brilinta (ticagrelor) is an anti-platelet (a type of blood-thinner). Due to the potential for prescribing and dispensing errors resulting from name confusion with these drugs, the FDA has decided to change Brintellix’s name to Trintellix in June 2016. Trintellix tablets will look the same as the Brintellix tablets. No other changes will be made to the label, packaging, or medicine.