Drug Safety

[Guest guest]

Dear Members,Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) April - June 2011 Product Name: Active Ingredient (Trade) orProduct ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information(as of July 31, 2011)Anagrelide HCl(Agrylin) and AspirinDrug interaction resulting in hemorrhagic eventsFDA is continuing to evaluate this issue to determine the need for any regulatory action.Asenapine maleate(Saphris)Oral blistering,Oral ulceration,Oral erosionFDA is continuing to evaluate these issues to determine the need for any regulatory action.Bevacizumab(Avastin)Osteonecrosis of jawFDA is continuing to evaluate this issue to determine the need for any regulatory action.Colistimethate sodium for injectionDeaths due to dosing confusion and medication errorsFDA is continuing to evaluate this issue to determine the need for any regulatory action.ISMP Alert June 29, 2011Dronedarone HCl(Multaq)Pulmonary toxicityFDA is continuing to evaluate this issue to determine the need for any regulatory action.Everolimus(Afinitor, Zortress)Acute and chronic pancreatitis,Gallbladder disorderFDA is continuing to evaluate these issues to determine the need for any regulatory action.Methotrexate sodium and Proton pump inhibitorsDrug interaction resulting in decreased

elimination of methotrexateFDA is continuing to evaluate this issue to determine the need for any regulatory action.Muscarinic receptor antagonist productsSomnolenceFDA is continuing to evaluate this issue to determine the need for any regulatory action.Sodium ferric gluconate complex(Ferrlecit)Anaphylactic reactionsFDA is continuing to evaluate this issue to determine the need for any regulatory action.Voriconazole(Vfend)Fluorosis and Periostitis with long-term

useFDA is continuing to evaluate this issue to determine the need for any regulatory action.Tarun Wadhwa

[Guest guest]

Dear Sir,Thanks for bringing nice discussion pertaining to black box warning. I have also gone through that article. Its really interesting. Sir as you said sometimes there may not be causal relationship which could be established to ensure the association between intake of drug and occurrence of adverse event. There has to be strong association based on meta analysis, strict vigilance, temporal relationship and other scientifically sound studies. It may not be applicable all the time.As there was incidence of rosiglitazone associated cardiovascular events. FDA had issues strict warning for use of Rosiglitazone based on certain studies but still many

studies showed contradictory results. Training of healthcare professionals is of utmost importance for strict vigilance of drug therapy. Your own experience with use of drug therapy could provide better insight into it.Tarun Wadhwa

Dear Members,

FDA urges “black box†warning on pediatric antidepressants

(read the attached article).

Tarun Wadhwa