Patients Taking Invokana Have an Increased Risk of Leg and Foot Amputations
The FDA reports that the type 2 diabetes medicine Invokana (canagliflozin) causes an increased risk of leg and foot amputations. Two large clinical trials showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo. Amputations of the toe and middle of the foot were the most common. Some patients had more than one amputation, some involving both limbs. Based on the clinical trial findings, the FDA is now requiring the most prominent Boxed Warning to be added to canagliflozin drug labels. Via FDA. Posted May 16, 2017.
Nonprescription use of Ritalin linked to adverse side effects, UB study finds
A University of Buffalo study found that the nonprescription use of the stimulant drug Ritalin was linked to unwanted side effects. Researchers examined changes in the brains of rats that received regular doses of Ritalin during what would be equivalent to adolescence in humans, a time of significant brain growth and development. Results found changes in brain chemistry associated with risk-taking behaviors, disruptions in the sleep/wake cycle and problematic weight loss. Via University of Buffalo. Posted May 17, 2017.
Too many postmarketing studies are never published
The FDA requires postmarket studies, including submission of status reports, for certain drugs. FDA researchers queried an internal database to identify all reportable postmarket drug studies classified as having been “fulfilled” by the FDA between 2009 and 2013. As of July 2016, 183 of the 288 postmarket studies (63.5%) meeting inclusion criteria were published in either the scientific literature or on the ClinicalTrials.gov website. More studies were published in journals than in the trial registry. Although there have been calls for more data sharing, publication rates for completed postmarket studies required by FDA remain low. Via JAMA. Posted May 15, 2017.