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Weekly Drug News Round-Up: July 27, 2016

AbbVie’s Once-Daily Viekira XR Approved for Genotype 1 Hepatitis C

Viekira XR is given once daily, while Viekira Pak is dosed twice a day Read More...

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir), a once-daily, extended-release tablet to treat chronic hepatitis C virus (HCV) genotype 1 infection, has been FDA-approved. Viekira XR is a fixed dose combination that contains the same ingredients as Viekira Pak, but in one single tablet. Viekira Pak is co-packaged with dasabuvir instead of having it all in one tablet. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. The XR tablet is used without ribavirin in genotype 1b patients and in combination with twice daily ribavirin in genotype 1a patients. Viekira XR should not be used in patients with moderate to severe hepatic impairment.

FDA Updates Warnings on Common Fluoroquinolone Class of Drugs

Providers should stop fluoroquinolones in patients with serious side effects and switch to a different class of antibacterial Read More...

The FDA has approved changes to the package inserts for a common class of antibacterial drugs taken by mouth or injection known as fluoroquinolones, which includes: Avelox (moxifloxacin), Cipro and Cipro extended-release (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin) and ofloxacin (generic). This class of drug may lead to serious, potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. In patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, other treatment options should be used when possible.

Synjardy: Patient Population Expanded for Diabetes Treatment

Nearly 28 percent of Americans with diabetes — totaling 8 million people — are undiagnosed Read More...

Synjardy, from Boehringer Ingelheim and Eli Lilly, is a combination of empagliflozin (Jardiance) and metformin, both medicines used to help control blood glucose in adults with type 2 diabetes. This week, the U.S. Food and Drug Administration (FDA) has approved an added use for Synjardy tablets to include treatment-naïve (never treated) adults with type 2 diabetes. Previously, Synjardy was approved to be used in patients who were either not controlled on either drug contained in the combination or who were already being treated with both agents. Side effects may include rare but serious lactic acidosis due to metformin.

Relistor Tablets Approved for Opioid-Induced Constipation

Valeant expects to begin US sales of Relistor Tablets in the third quarter of 2016 Read More...

Valeant and Progenics Pharmaceuticals announce the FDA approval of Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Relistor is given as a 450 mg once daily tablet. Previously, Relistor was approved in 2008 for treatment of OIC as a subcutaneous injection. Common side effects include stomach pain or distention, diarrhea, headaches, sweating, anxiety, muscle spasms, runny nose, and chills, some of which may be due to opioid withdrawal.

Managing Behavioral Issues in Dementia Patients Without Antipsychotics

The program focuses on resolving issues bothering the patients and not to automatically sedate them Read More...

Antipsychotic drugs like quetiapine (Seroquel) or aripiprazole (Abilify) carry the FDA’s strongest warning - a boxed warning - against use in elderly patients with dementia-related psychosis due to an increased risk of death. Yet, according to a report out this week, about 25 percent of dementia patients in U.S. nursing homes are still receiving these risky medications for behavioral issues. A small study suggests an attempt to manage these patients with specially-trained nurses, rather than medicating them, may have better results. Overall, of 135 patients taken off the antipsychotic drugs, 76 percent were still not using them 12 months later, the researchers said.