Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically [...]
Continue reading...19. September 2012
On September 19. 2012, FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart [...]
Continue reading...27. September 2012
In July GlaxoSmithKline, the UK’s largest drug manufacturer, pleaded guilty to criminal charges and agreed to a $3 billion settlement with states and the U.S. government over accusations that it improperly promoted its drugs for unapproved uses and failed to report safety data. 50,000 to 100,000 patients died from using Glaxo’s blockbuster diabetes drug Avandia [...]
Continue reading...20. September 2012
This past May, the FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine (May 17) reporting a small increase in cardiovascular deaths and in the risk of death from any cause in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated [...]
Continue reading...29. August 2012
GranuFlo and NaturaLyte Dialysis linked to Heart Attack The FDA issued the recall after learning of the severe cardiac risks associated with GranuFlo & NaturaLyte. GranuFlo & NaturaLyte have been recalled by the FDA. On March 29, 2012, the FDA issued a Class I Recall, which is the most severe sanction the FDA can impose. [...]
Continue reading...10. July 2012
Azithromycin, a macrolide antibiotic, had previously been thought to be relatively free of cardiotoxic effects. In a new review of azithromycin, however, the authors cited at least 20 reports submitted to the FDA relative to azithromycin-associated prolongation of QT syndrome, torsades de pointes and ventricular tachycardia. Two other drugs in this class, erythromycin and clarithromycin, [...]
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25. January 2013
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