Information technology is key to improving medication-related errors and improving medication adherence among older adults, according to a recent report from the Center for Technology and Aging in Oakland, CA. According to the report, "'widespread use' of technology aimed at this population could save thousands of lives and billions of dollars."
Column offers advice on treatment with bone-enhancing drugs.
Who should be treated with bone-enhancing drugs? Until recently, many doctors and drug companies that make these medications were saying almost everyone -- especially older white women, who are at highest risk of one day suffering an osteoporotic fracture." However, "the drugs currently available to enhance bone density" are "expensive...can have side effects, and they are only about 50 percent effective at preventing fractures." Brody suggests that patients with osteopenia should rely instead upon their FRAX risk assessment score, a "bone mineral density test," and their physician's guidance to weigh "possible risks...against known benefits" before starting treatment with such medicines.
Arena seeks FDA approval of weight loss drug.
The first of a new class of obesity drugs moved one step closer to the market as Arena Pharmaceuticals Inc. said it filed for approval of its drug candidate lorcaserin." If approved, the drug is likely to "compete against Vivus Inc.'s Qnexa and Orexigen Therapeutics Inc.'s Contrave32, both of which are still in development." According to Arena, two late-stage trials showed that obese and overweight patients with type 2 diabetes taking lorcaserin experienced significant weight loss, and that the drug was safe and tolerable.
The results appear to meet one of two FDA-recommended goals for obesity drugs: that at least 35 percent of patients taking its drug lose at least five percent of their body weight, and that the group is approximately double the percentage of patients with similar weight loss on the placebo.
Shire seeks full FDA approval of Replagal.
British drugmaker Shire allegedly filed for US marketing approval of its Fabry's disease treatment Replagal [agalsidase alfa]." The drug is currently "available under Food and Drug Administration restrictions.Shire established an early access program in the midst of a shortage in treatments marketed in the US for Fabry disease. The shortages have been caused by the temporary shutdown last summer of Genzyme's Allston Landing manufacturing plant, where the company discovered a virus in a bioreactor in June. If approved, the drug "would compete against" Genzyme's Fabrazyme [algasidase beta].
Also at http://www.qa-expert.com/2010/01/pharma-regulatory-qa-updates.html.