Expert opinion on drug safety
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Seizures in pregnancy are particularly challenging, as their management requires careful consideration of not only the etiology of the seizure, but also the physiologic changes of pregnancy as well as potential adverse effects on the developing embryo or fetus. Newer antiepileptic drugs (AEDs) have increasingly shown promising results of lower rate of teratogenesis, as well as better seizure control during pregnancy. ⋯ In summary, morbidity associated with seizure in pregnancy is decreasing as treatments and supportive therapies have improved. The understanding of teratogenesis as well as novel targeted therapeutics will allow women on AEDs during their pregnancy, to receive the safest drug for their developing fetus as well as themselves.
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Expert Opin Drug Saf · Aug 2015
Review Meta AnalysisManaging the safety of inhaled corticosteroids in COPD and the risk of pneumonia.
Inhaled corticosteroids (ICS) are known to increase the risk of pneumonia in patients with chronic obstructive pulmonary disease. To estimate the association between ICS and pneumonia among users of ICS relative to non-ICS users and to examine whether this risk is dose related, class related and what's its association with the pneumonia-mortality or overall mortality. ⋯ ICS alone or in combination with long-acting β-agonists are associated with an increased risk of pneumonia but have no effect on pneumonia related mortality. It is important to identify those patients to benefit the most from ICS, as those with frequent exacerbations, a severe airway obstruction, a positive bronchodilator test or a sputum eosinophilia despite treatment.
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Expert Opin Drug Saf · Aug 2015
ReviewLow-dose SoluMatrix diclofenac : a review of safety across two Phase III studies in patients with acute and osteoarthritis pain.
Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac , containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs. ⋯ The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.
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Olaparib (Lynparza®) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor that has become the first 'personalized' therapy available for patients with BRCA mutation-positive ovarian cancer (OC). A capsule formulation of the drug has recently received approval for use in this population for platinum-sensitive recurrent disease for maintenance therapy following platinum-based chemotherapy in Europe and as third- or fourth-line platinum-sensitive therapy in the USA. ⋯ Oral olaparib 400 mg twice daily has acceptable tolerability when administered as maintenance monochemotherapy in women with relapsed OC. The common toxicities - nausea/vomiting, fatigue and anemia - are mild or moderate in severity and appear consistent across subgroups (BRCA carriers/wild-type). Though the risk is low, long-term monitoring of patients is warranted to determine the potential risk for hematological complications such as anemia, myelodysplastic syndrome or acute myeloid leukemia.
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Expert Opin Drug Saf · Aug 2015
ReviewMinimizing chemotherapy-induced peripheral neuropathy: preclinical and clinical development of new perspectives.
Chemotherapy-induced peripheral neuropathies (CIPN) are a dose-limiting adverse effect of certain anticancer drugs (platinum salts, vinca alkaloids, taxanes, bortezomib, thalidomide, epothilones, eribulin). CIPN are mainly responsible for sensory disturbances and are associated with a decrease in quality of life. After the end of chemotherapy, CIPN can last for several months and even years. Unfortunately, recent meta-analyses of clinical trials have demonstrated that there is no univocal gold standard for the prevention and treatment of CIPN. ⋯ To date, based on meta-analyses of clinical trials, no drug can be proposed as a gold standard to prevent or treat CIPN. Consequently, there is a strong discrepancy between the optimistic results of animal studies and the poor outcomes of clinical trials. Pain assessment in preclinical and clinical studies is probably not the best outcome measurement tool and all these studies should include composite outcomes including the full complexity of CIPN symptoms, such as positive symptoms (pain, paresthesia, and dysesthesia) and negative ones (numbness).