CLINICAL CONTEXT Previously US Food and Drug Administration (FDA)–approved indications for pregabalin include diabetic neuropathy, postherpetic neuralgia, fibromyalgia, and partial-onset seizures in adults with epilepsy requiring at least 1 antiepileptic drug. Approximately 40% of patients with traumatic or nontraumatic spinal cord injury have associated neuropathic pain, which can be severely debilitating, may start as soon as 2 weeks after the injury, and could last up to 25 years. STUDY SYNOPSIS AND PERSPECTIVE The FDA has approved pregabalin ( Lyrica ) for the management of neuropathic pain associated with spinal cord injury. The drug was given priority review by the FDA for this indication, a statement from Pfizer notes, and brings to 5 the number of approved indications for pregabalin in the United States; others include diabetic neuropathy, postherpetic neuralgia, fibromyalgia, and partial-onset seizures in adults with epilepsy who take 1 or more drugs for seizures.
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CLINICAL CONTEXT In 1996, the US Food and Drug Administration (FDA) approved cefepime, a fourth-generation cephalosporin. It is commonly used for pharmacotherapy of pneumonia, urinary tract infection, skin and skin-structure infections, and complicated gastrointestinal tract infections. Routes of administration are intravenous or intramuscular. STUDY SYNOPSIS AND PERSPECTIVE The FDA is reminding healthcare professionals about the need to adjust the dosage of the antibacterial drug cefepime in patients with renal impairment. In an FDA Drug Safety Communication posted on the agency's Web site , the FDA says there have been cases of nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. "The Warnings and Precautions and Adverse Reactions sections of the cefepime label are being revised to highlight this risk," the FDA says. Cefepime is a
CLINICAL CONTEXT According to the current study by Adler and colleagues, proton-pump inhibitors (PPIs) are among the most commonly prescribed medications in the outpatient and inpatient settings worldwide and are generally thought to have a safe adverse effect profile. This trend has led to widespread use by clinicians. Clostridium difficile –associated diarrhea (CDAD) is a major cause of morbidity and increasing healthcare costs among hospitalized patients. Although exposure to antibiotics remains the most documented risk factor for CDAD, attention has recently been directed toward a possible link with PPIs. However, the evidence for this link remains controversial. This meta-analysis summarizes the association between PPIs and the risk for CDAD. STUDY SYNOPSIS AND PERSPECTIVE Evidence that proton-pump inhibitors (PPIs) increase the incidence of Clostridium-difficile -associated diarrhea (CDAD) is "sufficient," say the authors of a new meta-analysis. "We
CLINICAL CONTEXT In 2010, an estimated 10,000 new HIV infection occurred among US women. One in 139 women will be diagnosed with HIV during her lifetime. Prevention of unintended pregnancy among women at risk for HIV infection or among women infected with HIV is very important. In 2010, the US Centers for Disease Control and Prevention (CDC) published U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 , providing evidence-based guidance for the safe use of contraceptive methods among women with certain characteristics or medical conditions, including women who are at high risk for HIV infection or are HIV infected. Recently, the CDC assessed the evidence regarding hormonal contraceptive use and the risks for HIV acquisition, transmission, and disease progression. This report by Tepper and colleagues summarizes that assessment and the resulting updated guidance. STUDY SYNOPSIS AND PERSPECTIVE The CDC has updated its 2010 recommendations regarding the use of hormon
CLINICAL CONTEXT For the past 2 decades, statins have been in widespread use to reduce blood cholesterol levels. Significant evidence exists supporting the ability of statins to prevent cardiovascular events, but most of the clinical trials on the drugs have predominantly enrolled men. Results regarding the benefits of statins for secondary cardiovascular disease prevention in women with cardiovascular disease vs men have been conflicting. The objective of this meta-analysis by Gutierrez and colleagues was to determine if statin therapy is as effective in women as in men to reduce recurrent cardiovascular events. STUDY SYNOPSIS AND PERSPECTIVE The debate as to whether statins have less benefit in women than in men rumbles on. The latest contribution to this saga is a new meta-analysis suggesting that statins are effective in the secondary prevention of cardiovascular events in both men and women, but there is no significant benefit on stroke and all-cause mortality in women
FDA MedWatch - Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient
ISSUE : The device’s labeling erroneously states that the product “contains no medication,” however, the device contains chlorhexidine and silver sulfadiazine. Additionally, the product’s label is missing the appropriate chlorhexidine contraindication. If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, there is the potential for an allergic reaction presenting as a delayed rash, hives or potentially an immediate Type 1, IgE mediated anaphylaxis (loss of blood pressure, bronchospasm and vascular collapse). The product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine. BACKGROUND : The multiple-lumen catheter is inserted in a large vein to administer drug therapy. RECOMMENDATION : On May 3, 2012, the firm sent its distributors an Urgent Field Correction Action letter. In the letter, the firm asked
On Saturday, Burch Farms of North Carolina announced a recall of Athena cantaloupes because the product may contain listeria monocytogenes. No illnesses have been associated with this recall, according to Burch Farms.