Expert opinion on drug safety
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Invasive fungal diseases (IFDs) are a leading cause of morbidity and mortality among immunocompromised patients with bone marrow failure syndromes, hematological malignancies, hematopoietic stem cell transplantation (HSCT), those admitted in intensive care units (ICUs) and those with prolonged febrile neutropenia. IFDs occur in a setting of multiple morbidities and are associated with case fatality rates between 30 and 70%. ⋯ Areas covered: All antifungal agents, including amphotericin B formulations, echinocandins and the triazoles, may cause hepatic toxicity that ranges from mild and asymptomatic abnormalities in liver function tests to substantial liver injury and fulminant hepatic failure. Expert opinion: The present article reviews incidence and severity of hepatotoxicity associated with different classes and agents to provide a better understanding of this specific end organ toxicity and safer use of antifungal agents A thorough understanding of the distribution, metabolism, elimination and drug-drug interactions of antifungal agents used for management of IFDs in combination with safety data from clinical trials, pharmacokinetic and pharmacodynamic studies may guide the use of antifungal treatment in patients at high risk for the development of hepatic dysfunction and in those with underlying liver damage due to cytotoxic therapy.
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Expert Opin Drug Saf · Jan 2018
Review Comparative StudyA review of clinical safety data for sumatriptan nasal powder administered by a breath powered exhalation delivery system in the acute treatment of migraine.
AVP-825 (sumatriptan nasal powder) is an FDA-approved intranasal medication delivery system containing low-dose sumatriptan powder for acute treatment of migraine with or without aura in adults. AVP-825 utilizes unique nasal anatomy features to avoid limitations of other intranasal delivery methods. Areas covered: Literature search terms: 'AVP-825', 'sumatriptan nasal powder', 'intranasal sumatriptan', 'sumatriptan safety', 'sumatriptan acute migraine'. ⋯ AVP-825 has the advantage of early efficacy onset associated with faster absorption at a lower delivered dose than liquid nasal spray or oral formulations. AVP-825 provided earlier efficacy (within 30 min) vs. 100 mg oral sumatriptan and similar sustained efficacy. AVP-825 offers the benefits of a non-oral, low-dose, tolerable acute migraine medication.
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In the last few decades, the consumption of opioid analgesics in many countries, particularly the US, has dramatically increased. This rise has been paralleled by a proportional number of opioid-related deaths. Areas covered: The development of opioid guidelines was a response to this health crisis with the intention of reducing the risk of harm related to opioid prescribing. ⋯ Expert opinion: Many activities have been suggested to face the opioid epidemic. Reducing supply is one of the most relevant aspects. Clinicians should find a fine balance that meets the patient's need for pain relief while minimizing the chance for abuse.
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Expert Opin Drug Saf · Dec 2018
ReviewEvaluating the safety of emicizumab in patients with hemophilia A.
Patients affected by hemophilia A often require frequent prophylactic and therapeutic self-infusion. For those who develop inhibitors, treatment options are limited and mortality is increased. Emicizumab, a bispecific antibody to Factors IXa and X that carries out the function of Factor VIII (FVIII), represents a novel therapeutic approach. ⋯ Three patients developed a thrombotic microangiopathy (TMA) and two patients had thrombotic events while on emicizumab in combination with activated prothrombin complex concentration (aPCC) alone or concurrent with activated recombinant factor FVII (rFVIIa). Expert opinion: Emicizumab represents a much-needed alternative approach to managing Factor VIII deficiency, especially for those with inhibitors or limited ability to self-infuse. For patients with inhibitors, thrombotic complications including TMA, not seen with other bypassing agents, raises concern about the use of emicizumab in combination with aPCC and how patients who have breakthrough bleeding can be safely managed.
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Expert Opin Drug Saf · Dec 2016
ReviewRiociguat for the treatment of pulmonary hypertension: a safety evaluation.
The development of pulmonary hypertension (PH) has multifactorial underlying pathophysiological causes and can be classified into five groups. While three different classes of therapeutic drugs are licensed for the treatment of pulmonary arterial hypertension (PAH, WHO group 1), specific medical therapies are lacking for other forms of PH, such as PH due to left heart disease. In 2013 riociguat, a first-in class soluble guanylate cyclase stimulator, has also become available for the treatment of PAH. ⋯ Despite these advances in therapeutic options for patients with PH, none of these agents have been approved for the treatment of PH due to left heart disease. Areas covered: We aim to give an overview of the pathophysiology of PH, pharmacodynamics and pharmacokinetic properties, safety and efficacy of riociguat, including adverse events, contraindications and drug interactions. Expert opinion: Considering the increasingly broad indications for riociguat in patients with PH, substantial knowledge of data and properties on safety and efficacy of riociguat are becoming more and more important for physicians prescribing riociguat to PH patients.