Expert opinion on drug safety
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Expert Opin Drug Saf · Aug 2015
ReviewSafety and efficacy of paracetamol and NSAIDs in osteoarthritis: which drug to recommend?
Osteoarthritis (OA) is the most common form of arthritis and is a major cause of disability, especially in people ≥ 45 years old. Several international societies recommend the use of both acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) to alleviate OA pain. However, patients with OA often have comorbidities, notably cardiovascular risk factors, which may hamper the use of these analgesics. ⋯ Given the putative gastrointestinal and cardiovascular toxicity and poor analgesic properties of acetaminophen in OA, its use in patients with risk factors is questionable. Acetaminophen should be used at the lowest effective dosage and for the shortest time in all OA patients. Given the different safety profiles, the choice of NSAIDs, traditional or coxibs, should be based on individual patient risk factors. A good knowledge of the different strategies to decrease the gastrointestinal and cardiovascular toxic effects of NSAIDs is key to the management of OA.
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Pain management with opioids is a fundamental element of palliative medicine. Since the risks of chronic opioid therapy have emerged, a reassessment of these risks in the setting of palliative care is warranted. ⋯ Palliation of severe pain at the end of life is probably the most widely accepted indication for chronic opioid therapy. At increased doses, adverse effects of opioids may limit or interfere with the benefits of treatment. Careful screening and follow-up will allow risk factors to be recognized and addressed when possible. The use of adjunctive treatments for pain may reduce opioid requirements and yield better outcomes.
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Expert Opin Drug Saf · Jul 2015
Randomized Controlled TrialRadium-223 dichloride for the treatment of bone metastatic castration-resistant prostate cancer: an evaluation of its safety.
Approximately 10 - 20% of prostate cancer cases ultimately progress to castration-resistant prostate cancer (CRPC), for which there is a poor prognosis and a therapeutic need. Radium-223 dichloride (radium-223 [Xofigo]) is a first-in-class α-emitting radiopharmaceutical shown to significantly prolong overall survival in patients with CRPC with symptomatic bone metastases and no visceral metastases. Current treatment guidelines recommended it in both pre- and post-docetaxel settings. ⋯ The pronounced efficacy and safety profile of radium-223 positions it as a valuable new therapeutic tool in the CRPC armamentarium. Its novel mechanism of action underlies low rates of hematologic adverse events. Radium-223 treatment will become common in the majority of pre-docetaxel symptomatic CRPC cases, as it has proved to be highly efficient with few safety concerns earlier in the course of disease.
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Expert Opin Drug Saf · Jun 2015
ReviewSafety of selective serotonin reuptake inhibitor treatment in recovering stroke patients.
Selective serotonin reuptake inhibitors (SSRIs) are widely used for psychiatric complications after stroke. Studies have indicated additional effects, and SSRIs could potentially be used as enhancers of stroke recovery. However, beneficial effects should be weighed against potential adverse effects. In particular, the possible association with cerebrovascular events has raised concern. ⋯ Evidence suggests that SSRIs may enhance stroke recovery. Most studies on cerebrovascular risk are from non-stroke populations and little is known about recurrent events and mortality post-stroke. In non-stroke populations treatment has been associated with increased risk of intracerebral and intracranial hemorrhage; however the absolute risk is low. The association between SSRIs and ischemic stroke is less clear. Randomized stroke trials indicate that treatment is safe and well tolerated, and the most common side effects are often benign and transient. The trials are small however and not powered to detect potential differences in cerebrovascular events. We await several ongoing large randomized trials before SSRIs can be recommended as a routine pharmacotherapy in stroke recovery.
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Expert Opin Drug Saf · Jun 2015
ReviewSafety of intravenous thrombolysis for acute ischemic stroke in specific conditions.
Intravenous administration of tissue-type plasminogen activator (IV-tPA) remains the only approved therapy that may reverse neurological deficit in patients with acute ischemic stroke (AIS). During the past 20 years, accumulating real-word experience have provided additional information regarding its safety and efficacy in various clinical settings that were originally considered as contraindications for systemic thrombolysis. ⋯ The present narrative review summarizing 20 years of clinical experience with IVT for AIS highlights that many of the current guidelines and protocols should be adjusted to accommodate recent data from registries and real-world experience underscoring the safety of IVT in numerous conditions of AIS that were originally considered as relative or absolute contraindications for administration of IV-tPA.