Expert opinion on drug safety
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Expert Opin Drug Saf · Jan 2015
EditorialThe safety of liposome bupivacaine 2 years post-launch: a look back and a look forward.
The need for better post-surgical pain management continues to be unmet, despite clinicians' awareness and concern for many years. Opioids remain the standard of care because of their analgesic efficacy; however, opioid use is often associated with adverse effects and poor patient outcomes. Multimodal analgesic regimens have recently been endorsed as a way to provide adequate post-surgical pain control while reducing opioid consumption. ⋯ Based on the available clinical trial data compiled to date, as well as the author's review of publicly available post-marketing safety information, liposome bupivacaine may be a viable addition to currently available therapeutic options for post-surgical analgesia while reducing potential risks associated with use of opioid analgesics, and may represent a useful addition to the multimodal analgesic modalities currently used for post-operative pain management. The potential for its use in other areas is also being investigated. The purpose of this review is to examine the currently available post-marketing safety information on liposome bupivacaine.
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There is some evidence for a partial opioid switching or an 'add on' approach to opioid dosing strategies. Preclinical and clinical findings suggest different activation profiles for the stimulation of the mu subtypes, raising the questions about what might occur with combinations of these substances. In the postoperative setting, it seems that the analgesic effect of the combination at equivalent doses is similar to that produced by the individual components, not adding particular advantages. ⋯ In chronic pain, information is still in the infancy, but opioid combination therapy may have greater advantages in improving the opioid response. The possibility to clinically translate opioid combinations into practice, as demonstrated in some animal models, depends on a broad number of factors implicated in the pain process. More research is needed to better elucidate these issues in the near future.
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Expert Opin Drug Saf · Nov 2014
ReviewAre incretin mimetics and enhancers linked to pancreatitis and malignant transformations in pancreas?
Dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists are new options in the treatment of type 2 diabetes mellitus. However, due to accumulating reports on the occurrence of acute pancreatitis (AP), a suspicion of an association between incretin-based therapies and pancreatic disease has arisen. ⋯ Until now, several preclinical and clinical studies have been published; however, they present conflicting results. Common risk factors, low incidence rates, long latency periods (in regard to pancreatic malignancy), lack of availability of human pancreatic tissues during lifetime among others hamper the confirmation or exclusion of a causal association. The results of the ongoing large randomized controlled trials will add further data. In line with current recommendations by European Medicines Agency and FDA, incretin-based therapies should be discontinued in patients with suspicion of AP, and incretin mimetics should not be administered to patients with a history of AP. However, based on current knowledge, there is no sound reason for depriving type 2 diabetic patients in general of a beneficial and effective therapy. However, this conclusion cannot be final and should be subject to constant reevaluation and, if necessary, change.
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Expert Opin Drug Saf · Nov 2014
ReviewCardiovascular risk associated with sodium-containing medicines.
It is widely recognized that excess sodium intake increases the risk of hypertension, and this subsequently increases the risk of cardiovascular disease. Although efforts are being made to reduce sodium intake in the population in general, there are concerns that a considerable sodium load can be ingested via certain effervescent, dispersible, and soluble formulations of medicines. ⋯ Sodium-containing formulations should be prescribed with caution only if the perceived benefits outweigh the risks.