People 75 or over who take aspirin daily over the long term may have a higher than expected risk of serious or even fatal bleeding. Researchers followed 3,166 patients who previously had a stroke or heart attack and were prescribed antiplatelet drugs which were mostly aspirin. A total of 314 patients were admitted to hospital for bleeding over the course of 10 years. Results found that the risk of fatal or disabling bleeding increased with age. Between 40% and 60% of Americans 75 and over take an aspirin to prevent a heart attack or stroke, and aspirin is routinely given to seniors who have experienced one of those events. Researchers say patients 75 and older taking aspirin daily should also be given a heartburn drug, known as a proton-pump inhibitor, to reduce the risk of bleeding. Posted June 13, 2017. Via The Lancet.
Many drugs under the FDA’s “accelerated approval” program are approved with questionable data. A London School of Economics study examined 37 new FDA-approved drugs that were granted “accelerated approval” status between 2000 and 2013. Drugs granted such status are typically for conditions where there is an urgent medical need and the treatment is considered “reasonably likely” to provide clinical benefits. However, researchers found that the standard for approval is significantly lower than for drugs going through the normal approval process. The authors say that basing approval on surrogate – or secondary – measures from trials that are easy to obtain rather than more meaningful clinical outcomes gives a false impression of the drug’s actual benefit. Posted June 7, 2017. Via The Milbank Quarterly.
The FDA will hold a 2-day meeting on July 10 and 11 to examine whether measures on abuse-deterrent opioids are effective. The announcement comes in the wake of the agency’s request last week that Endo pull its opioid Opana ER from the market over abuse concerns. The FDA’s overarching goals are to reduce the number of new cases of addiction and to evaluate whether opioid medications with abuse-deterrent properties are having their intended impact on limiting abuse and helping to curb the epidemic. Many prescription opioids have abuse-deterrent claims on the labeling, meaning they are difficult to snort or inject if crushed. The FDA already requires manufacturers of these drugs to conduct post-market studies on them to evaluate their abuse-deterrent effectiveness. Posted June 13, 2017. Via FDA.