Prolonged Pulseless Electrical Activity Cardiac Arrest After Intranasal Injection of Lidocaine With Epinephrine: A Case Report.

Local anesthetic toxicity is a rare but serious complication of local anesthetic administration. Although lidocaine has a safety profile superior to other amide local anesthetics, we report a case of cardiac arrest after intranasal injection of lidocaine. The case involves a 22-year-old healthy woman who experienced pulseless electrical activity shortly after a submucosal injection of 2.2 mg/kg of lidocaine with epinephrine. Resuscitative efforts were unsuccessful until a bolus of intralipid was given. This case emphasizes that even a "low" dose of a less lipophilic drug has the potential for severe toxicity.

Aggressiveness of care following intracerebral hemorrhage in women and men.

OBJECTIVE: To compare comorbidities and use of surgery and palliative care between men and women with intracerebral hemorrhage (ICH). METHODS: The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study is a prospective, multicenter, case-control study of ICH risk factors and outcomes. We compared comorbidities, treatments, and use of do-not-resuscitate (DNR) orders in men vs women. Multivariate analysis was used to assess the likelihood of ICH surgery and palliative care after adjustment for variables that were p < 0.1 in univariate analyses and backward elimination to retain those that were significant (p < 0.05). RESULTS: Women were older on average (65.0 vs 59.9, p < 0.0001), and higher proportions of women had previous stroke (24.1% vs 19.3%, p = 0.002), had dementia (6.1% vs 3.4%, p = 0.0007), lived alone (23.1% vs 18.0%, p = 0.0005), and took anticoagulants (12.8% vs 10.1% p = 0.02), compared with men. Men had higher rates of alcohol and cocaine use. After adjusting for age, hematoma volume, and ICH location, there was no difference in rates of surgical treatment by sex (odds ratio [OR] 0.93 for men vs women, 95% confidence interval [CI] 0.68-1.28, p = 0.67), and there was no difference in DNR/comfort care decisions after adjustment for ICH score, prior stroke, and dementia (OR 0.96, CI 0.77-1.22, p = 0.76). CONCLUSIONS: After ICH, women do not receive less aggressive care than men after controlling for the substantial comorbidity differences. Future studies on sex bias should include the presence of comorbidities, prestroke disability, and other factors that may influence management.

New-Onset Refractory Status Epilepticus with Claustrum Damage: Definition of the Clinical and Neuroimaging Features.

New-onset refractory status epilepticus (NORSE) is a rare but challenging condition occurring in a previously healthy patient, often with no identifiable cause. We describe the electro-clinical features and outcomes in a group of patients with NORSE who all demonstrated a typical magnetic resonance imaging (MRI) sign characterized by bilateral lesions of the claustrum. The group includes 31 patients (12 personal and 19 previously published cases; 17 females; mean age of 25 years). Fever preceded status epilepticus (SE) in 28 patients, by a mean of 6 days. SE was refractory/super-refractory in 74% of the patients, requiring third-line agents and a median of 15 days staying in an intensive care unit. Focal motor and tonic-clonic seizures were observed in 90%, complex partial seizures in 14%, and myoclonic seizures in 14% of the cases. All patients showed T2/FLAIR hyperintense foci in bilateral claustrum, appearing on average 10 days after SE onset. Other limbic (hippocampus, insular) alterations were present in 53% of patients. Within the personal cases, extensive search for known autoantibodies was inconclusive, though 7 of 11 patients had cerebrospinal fluid lymphocytic pleocytosis and 3 cases had oligoclonal bands. Two subjects died during the acute phase, one in the chronic phase (probable sudden unexplained death in epilepsy), and one developed a persistent vegetative state. Among survivors, 80% developed drug-resistant epilepsy. Febrile illness-related SE associated with bilateral claustrum hyperintensity on MRI represents a condition with defined clinical features and a presumed but unidentified autoimmune etiology. A better characterization of de novo SE is mandatory for the search of specific etiologies.

Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.

In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including "biobetters," which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.

Does generic entry always increase consumer welfare?

This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into account the generic free riding problem. It demonstrates that changes in competition along dimensions other than retail price--such as competition in research and development efforts and in promotional activities--may, in certain situations, result in generic entry having an overall negative impact on consumer welfare.