The FDA approved Belsomra (suvorexant) for insomnia, the first orexin receptor antagonist, in 5, 10, 15 and 20 mg strengths. It is taken once a night within 30 minutes of bed with at least seven hours before waking; drowsiness was the most commonly reported adverse reaction in trials.
Section archive
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Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
NSAIDs fight breast cancer
A retrospective analysis found that overweight and obese postmenopausal breast cancer patients on hormone therapy who used NSAIDs had half the recurrence rate and more than two extra disease-free years. The investigators call the results preliminary and are running studies to confirm them.
Drug
Clodronate effective in preventing fractures
A University of Siena meta-analysis of 18 trials found patients treated with clodronate had 43 percent lower risk of new vertebral fractures, 33 percent lower risk of non-vertebral fractures and 25 percent lower overall fracture risk than those who did not take it.
Drug
Acetaminophen Overdose Is Far Easier Than You Might Think
Acetaminophen sends more than 80,000 Americans to emergency rooms a year, and the gap between a safe and a harmful dose is narrow: 25 percent above the daily maximum, two extra-strength pills, can damage the liver within a couple of weeks. It appears in more than 600 drugs.
Drug
FDA approves new type of sleep drug, Belsomra
The FDA approved Belsomra (suvorexant), the first orexin receptor antagonist, for trouble falling and staying asleep. It comes in 5, 10, 15 and 20 mg strengths, taken once a night at least seven hours before waking. Drowsiness was the most commonly reported adverse reaction.
Drug
Safety of weight loss drugs
A rundown of anti-obesity drugs: fenfluramine, sibutramine and rimonabant withdrawn over heart valve, cardiovascular and psychiatric harms; orlistat often not tolerated; phentermine and diethylpropion capped at 12 weeks; lorcaserin and phentermine-topiramate approved but untested long term.
Drug
Metformin impairs cognition in type 2 diabetics
Australian researchers found people with diabetes were 51% more likely than non-diabetics to show worse cognitive performance, and that among diabetics, those treated with metformin were 123% more likely to perform worse than those not on the drug.
Drug
Bisphosphonates do not reduce breast cancer risk
Pooled data from two randomized trials, FIT and HORIZON-PFT, showed no significant difference in postmenopausal breast cancer rates between women assigned bisphosphonates and those on placebo, cutting against observational reports that the osteoporosis drugs protect against the disease.
Drug
FDA approves donor lung preservation device that may result in more lung transplants
FDA approved the XVIVO Perfusion System with STEEN Solution, which warms donated lungs to near body temperature and flushes them with a sterile fluid, giving clinicians more time to judge whether organs that miss standard criteria are transplantable. About one in five donated lungs now qualifies.
Drug
Statins cause neuropsychiatric disorders?
Italian pharmacovigilance researchers write in CNS Drugs that spontaneous adverse-event reports link statin treatment to neuropsychiatric reactions - behavioral changes, memory and cognitive problems, sleep disturbance and sexual dysfunction - though the drugs are generally well tolerated.
Drug
FDA approves Orbactiv to treat skin infections
The FDA approved Orbactiv (oritavancin), an intravenous antibacterial for adults with acute bacterial skin infections caused by certain bacteria, including MRSA. It is the third such drug cleared in 2014 and got priority review as a Qualified Infectious Disease Product.
Drug
Statin use boosts diabetes mellitus risk
A cohort study of more than 2 million UK patients found statin users had a 57 percent higher rate of type 2 diabetes, with longer use linked to greater risk. The authors stress this was not a trial and cannot show statins caused the added risk.
Drug
FDA approves Jardiance to treat type 2 diabetes
FDA approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The SGLT2 inhibitor blocks glucose reabsorption in the kidney; seven trials in 4,480 patients showed better A1c levels than placebo.
Drug
What you need to know after total hip arthroplasty?
A meta-analysis of seven studies covering 1,069 periprosthetic fractures found advanced age, revision surgery and rheumatoid arthritis carried the highest risk after total hip arthroplasty, with female sex, osteonecrosis and the Exeter implant each linked to 50 percent higher risk.
Drug
FDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The FDA widened Imbruvica's approval to chronic lymphocytic leukemia patients carrying a 17p chromosome deletion, who respond poorly to standard treatment, and updated the label after survival data confirmed the benefit behind its February 2014 accelerated approval.
Drug
Faster, Easier Cures for Hepatitis C
FDA's Jeffrey Murray says newly approved drug therapies give the 3.2 million Americans with chronic hepatitis C a chance at a cure with regimens that are easier to take. Three in four patients are baby boomers, many unaware they carry the virus, and a simple blood test can detect it.
Drug
FDA Teams Up for Novel Campaign on Risks of Decorative Contact Lenses
FDA, the American Optometric Association and the Entertainment Industries Council produced two public service videos with artists from American Horror Story, warning that decorative contact lenses not fitted by an eye doctor can cause infections leading to blindness.
Drug
Hepatitis C virus antiviral therapy can cause paranoid psychosis, cognitive impairment
A case report describes a 55-year-old man who developed paranoid psychosis and cognitive impairment after four months of interferon-based hepatitis C therapy. The psychosis lifted once he stopped treatment and took risperidone, but the cognitive impairment did not reverse.
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