Expert opinion on drug safety
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Expert Opin Drug Saf · May 2012
ReviewAdverse effects of topical anesthetics for dermatologic procedures.
Topical anesthetics are frequently used to decrease the pain associated with a variety of procedures including cutaneous surgery, cosmetic treatments and laser surgery. They are also routinely used in children prior to invasive procedures, such as venipuncture. The ideal topical anesthetic should safely increase patient comfort associated with these procedures with minimal potential for adverse effects. ⋯ Medical practitioners can mitigate the risk of side effects and toxicity with careful selection of anesthetic type, concentration, body location and dermatologic procedure. Compounded formulations should be used with caution in medical settings only on limited body surface areas without occlusion. This review presents a detailed analysis of products available, reported complications and an outline for appropriate use of topical anesthetics in combination with dermatologic procedures.
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Beta-lactam antibiotics are among the most clinically useful antimicrobials used in medicine. Unfortunately, adverse events related to their use remain poorly understood by many clinicians and, in particular, the misdiagnosis of β-lactam allergy and misunderstanding of crossreactivity among members of the β-lactam antibiotics may effectively eliminate a whole class of antimicrobials from use and require the use of broader spectrum agents with less well-established safety profiles. ⋯ Beta-lactams are generally safe drugs and serious adverse events are rare and allergy is overdiagnosed. Accurate diagnosis can usually be achieved through careful history and in some instances skin or in vitro testing is required. Even among individuals with true immediate-type allergy to penicillin, most cephalosporins are readily tolerated and desensitization is usually an option in cases where no alternate antimicrobials are available. Other allergic reactions (Type II, III and IV) are rare and avoidance of the culprit agent is generally recommended. Nonallergic or morbilliform rashes are generally not allergic in nature and should not prompt drug or class avoidance. Other adverse events are frequently dose-related and can be avoided by appropriate dosing and consideration of renal function.
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Expert Opin Drug Saf · Mar 2012
ReviewPharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.
Enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the FDA to require manufacturers to submit Risk Evaluation and Mitigation Strategy (REMS) when it was deemed necessary to ensure that a drug's benefit outweigh its risk. REMS apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs). The objective of this review is to describe the impact of REMS requirements on the pharmaceutical industry. ⋯ The new powers ascribed to the FDA are notable, as they add enforceability to safety strategies that were not part of FDA's prior risk management tools, risk minimization action plans (RiskMAPs). Failure to comply with REMS can lead to financial penalties up to $10 million, and a drug could be deemed misbranded if the REMS is not followed. The new approach to risk management via FDAAA has elevated the rigor with which manufacturers must fulfill postmarketing safety commitments.
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Expert Opin Drug Saf · Jan 2012
ReviewAre constipation drugs effective and safe to be used in children? A review of the literature.
Functional constipation is a common and often enduring problem in childhood. Although functional constipation is well defined by the Rome III criteria, these criteria have not always been integrated in general practice. Early diagnosis and treatment are key factors with respect to successful long-term outcome, as chronic constipation has a negative effect on the quality of life and is a burden for the public healthcare system. The safety of laxatives used for paediatric-functional constipation is based on well-designed trials carried out mostly in adults. Therefore, we conducted a review of the literature outlining the evidence for the efficacy and safety of laxatives used in chronic paediatric-functional constipation. ⋯ In adults, new promising drugs are on the virtue of breaking through in the treatment of chronic constipation. Carrying out well-defined placebo-controlled trials in children should be the next step before using these drugs.
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Expert Opin Drug Saf · Jan 2012
ReviewSafety and tolerability of extended-release niacin with laropiprant.
Niacin is one of the oldest drugs used in the treatment of dyslipidemia. Previously its use has been limited because of excessive flushing. Now an agent laropiprant (LRP) has been developed, which blocks the flushing pathway. Therefore, it is time to collate available information to assess the safety and tolerability of combining niacin with LRP. ⋯ The addition of LRP to ERN, by reducing the side effect 'flushing', may enable lipidologists and physicians to use niacin more widely as part of lipid modification therapy, especially since the combination can be safely added to statins. However, it has to be accepted that the addition of LRP does not completely abolish flushing. The favorable safety profile supports the use of LRP to achieve higher therapeutic dosing of niacin.