Expert opinion on drug safety
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Expert Opin Drug Saf · May 2013
ReviewLenalidomide and thalidomide in the treatment of chronic pain.
The immunomodulatory and anti-inflammatory drug thalidomide was first introduced in 1957 as a sleep aid and treatment for morning sickness. It was subsequently removed from the market due to severe teratogenic side effects and then returned to the market as a treatment for myelodysplastic syndrome and multiple myeloma. Lenalidomide is an analog of thalidomide with similar efficacy but improved side-effect profile. There are reports and studies of both agents for the treatment of chronic pain, especially complex regional pain syndrome (CRPS). Effective medical and interventional therapies for CRPS are limited. The use of novel immunomodulatory and anti-inflammatory drugs such as thalidomide and lenalidomide may offer a new approach to the treatment of CRPS. ⋯ Lenalidomide has a more favorable adverse effect profile compared to its parent compound thalidomide. Both agents, however, have significant potential adverse effects. Evidence of efficacy for chronic pain syndromes such as CRPS remains limited. Further studies are needed before these agents can be recommended for use in CRPS or other chronic pain syndromes.
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Expert Opin Drug Saf · May 2013
Application site adverse events associated with the buprenorphine transdermal system: a pooled analysis.
To characterize the profile of application site reactions (ASRs) for patients treated with the buprenorphine transdermal system (BTDS) in chronic pain studies. ⋯ Incidence rates of ASRs in patients treated with BTDS were low and infrequently led to discontinuation. Severe and inflammatory-type ASRs were not common. The ASR profile of BTDS was comparable with those of other transdermal patches.
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Expert Opin Drug Saf · May 2013
Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs.
To determine the relationship between boxed warnings issuance by the US Food and Drug Administration (FDA) and the proportional reporting rates of the associated adverse drug reactions (ADRs) to the FDA's Adverse Event Reporting System (FAERS) for multiple myeloma (MM) drugs. ⋯ Boxed warnings were associated with increased FAERS reporting, indicating increased awareness of ADRs for MM drugs. Proactive pharmacovigilance programs, such as the FDA's Mini-Sentinel Project, may improve timeliness of detection of rare ADRs.
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Expert Opin Drug Saf · Mar 2013
ReviewClinical safety of biosimilar recombinant human granulocyte colony-stimulating factors.
A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. ⋯ All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.
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Expert Opin Drug Saf · Jan 2013
ReviewAnticoagulation in atrial fibrillation and co-existent chronic kidney disease: efficacy versus safety.
Patients with atrial fibrillation (AF) and chronic kidney disease (CKD) are individually associated with a higher incidence of stroke as compared with the general population. Over the last two decades, an increase in prevalence of AF is seen in patients with CKD. While long-term anticoagulation with warfarin is well established to reduce the risk of thromboembolic event in patients with AF, its safety and efficacy has not been documented in patients with severe CKD. ⋯ Long-term anticoagulation with warfarin under strict monitoring appears to be the cornerstone of therapy in patients with CKD to prevent stroke. Further research is warranted to explore the safety and efficacy of newer anticoagulant agents in these high-risk patients in order to reduce the incidence of disabling stroke.