December 2007 Archives

Further Evidence of CV Harm With Rosiglitazone

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GSKMore evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.

The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.

Desmopressin Nasal Spray No Longer Indicated for Bed-Wetting

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Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).