Most recent by Rhonda Cooper-DeHoff, PharmD
Postmarketing drug safety surveillance: Is enough being done?
Lately, there has been much in the news regarding new and ongoing safety concerns related to a variety of sometimes very commonly used drugs. For example, based on data from a meta-analysis, angiotensin receptor blockers have recently been associated with a modest increase in the risk for a new cancer diagnosis. Similarly, since its approval in 2009, additional information regarding prasugrel’s (Effient, Daiichi Sankyo/Eli Lilly and Company) association with new and worse malignancies has recently become available.
Postmarketing Drug Safety Surveillance – Is Enough Being Done?
Lately, there has been much in the news regarding new and ongoing safety concerns related to a variety of sometimes very commonly used drugs. For example, based on data from a meta-analysis, angiotensin receptor blockers (ARBs) have recently been associated with a modest increase in the risk for a new cancer diagnosis. Similarly, since its approval in 2009, additional information regarding prasugrel’s (Effient, Daiichi Sankyo/Eli Lilly and Company) association with new and worse malignancies has recently become available. During the last few years, there have been mounting concerns regarding rosiglitazone (Avandia, GlaxoSmithKline) and an association with increased risk for CV events, culminating with the FDA’s review of the safety issues associated with rosiglitazone in a joint meeting of the Endocrinological and Metabolic Drugs and the Drug Safety and Risk Management advisory committees on July 13 and 14. After a thorough review of the data available to the advisory committee members, there was a clear lack of consensus as to where to go from here with regard to the status of rosiglitazone. One third of members suggested the safety signal is too strong to allow rosiglitazone to stay on the market, while the other two third felt the drug should stay on the market with additional warnings.
Perioperative anticoagulation strategies for pacemakers or ICDs
According to American Heart Association statistics, approximately 532,000 patients underwent procedures related to implantation of cardiac pacemakers or implantable cardiac defibrillators in 2006. Given other pre-existing conditions, a large number of these patients may also be administered oral anticoagulation with warfarin or another coumarin derivative. This necessitates appropriate management of anticoagulant therapy perioperatively to balance the risk for thromboembolism from the underlying disease process with the risk for bleeding complications (particularly the development of pocket hematomas) associated with the procedure. Although no formal guidelines exist, several available articles have examined possible management strategies for this patient population.