FDA advisers recommend easing Avandia restrictions
July 15th 2013FDA advisers recommended in early June the easing of restrictions on the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline), following an independent re-examination of GSK’s RECORD study conducted by Duke Clinical Research Institute.
Walgreens agrees to pay $80 million in DEA settlement
July 15th 2013Walgreens, the largest pharmacy chain in the United States, has agreed to pay $80 million in civil penalties for record-keeping and dispensing violations under the Controlled Substances Act, according to statements released June 11 by the company and the Drug Enforcement Agency (DEA).
Long-term data reinforce safety profile of dabigatran etexilate mesylate
July 15th 2013Results from the RELY-ABLE trial, the RE-LY extension study, support the long-term safety profile of dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) 150 mg twice daily in patients with nonvalvular atrial fibrillation (NVAF), according to a study published in Circulation.
Long-term data reinforce safety profile of dabigatran
July 15th 2013Results from the RELY-ABLE trial, the RE-LY extension study, support the long-term safety profile of dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) 150 mg twice daily in patients with nonvalvular atrial fibrillation (NVAF), according to a study published in Circulation in mid-June.
Report: CVD risk factors that pharmacists can address
July 15th 2013The Community Preventive Services Task Force, an independent, uncompensated panel of public health and prevention experts, has released 3 recommendations to address risk factors for cardiovascular disease. Pharmacists were included as members of the team to help with interventions for CVD prevention.
FDA seeks comments on drug importation regulations by August 12
July 15th 2013FDA is asking the public for advice on how to carry out Title VII. Among numerous other questions it is requesting comments on what information should be required at the time of entry to demonstrate a drug’s compliance, including information on homeopathic drugs for human use, articles for human or animal drug compounding, and drugs intended for research.
Industry giants partner to combat illegal, online pharmacies
July 12th 2013A nonprofit dedicated to ensuring online pharmacy safety, whose roots date back to an informal advocacy group started 4 years ago, was this week officially chartered in Washington, D.C. The board of the Alliance for Safe Online Pharmacies includes industry leaders from the National Association of Chain Drug Stores, Eli Lilly, LegitScript, and FWD Strategies International.
U.S. population health improving, but trailing other wealthy nations
July 10th 2013Life expectancies and the overall health of the United States’ population have improved over the past 2 decades. But those improvements have not kept pace with improvements in other wealthy nations, according to an online study in JAMA.
Concomitant control of BP, cholesterol is difficult
July 9th 2013Many patients suffer from both hypertension and high cholesterol, putting them at greater risk of coronary heart disease. Controlling the hypertension and high cholesterol would reduce CHD risk by 50% or more, but less than a third of patients have achieved adequate control of both, according to an online study in Circulation.
Fresenius Kabi recalls 4 lots of benztropine mesylate injection
July 3rd 2013Fresenius Kabi USA on June 30, 2013 issued a voluntary, user-level product recall of 4 lots of benztropine mesylate injection, USP, 2 mg/2 mL (1 mg/mL) in 2 mL single-dose vials, due to the possibility of glass particles in the vials.
FDA approves first nonhormonal treatment for hot flashes associated with menopause
July 2nd 2013FDA has approved low-dose paroxetine capsules (Brisdelle, Noven Pharmaceuticals), 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms associated with menopause, also referred to as hot flashes and night sweats.
Women at increased risk for opioid-related death
July 2nd 2013Opioid overdose deaths in women in the United States increased fivefold from 1999 to 2010. During the same time period, the risk of opioid pain reliever deaths in men increased 3.6 times, according to the July 2 Morbidity and Mortality Weekly Report.