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MedWatch Safety Alerts for Cardiovascular Drugs

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professionals and patients.

2013

Product Name	Date Issued/Updated
Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms	03/12/2013

2012

Product Name	Date Issued/Updated
Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms	03/28/2012
Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure	09/19/2012
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves	12/19/2012
Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury	03/01/2012
Statin Drugs - Drug Safety Communication: Class Labeling Change	02/28/2012
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death	05/17/2012

2011

Product Name	Date Issued/Updated
Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events	11/04/2011
Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack	03/01/2011
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed	06/02/2011
Benicar (olmesartan): Ongoing Safety Review	04/14/2011
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency	05/03/2011
Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events	12/19/2011
Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury	01/14/2011
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events	11/02/2012
Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements	03/30/2011
Trilipix (fenofibric acid): Drug Safety Communication - Label Change	11/09/2011
Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage	02/21/2011
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations	12/15/2011
Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms	09/15/2011

2010

Product Name	Date Issued/Updated
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed	06/02/2011
Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms	12/17/2010
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety	02/22/2010
Coumadin 1 mg Tablet Blister Packs: Recall	07/14/2010
GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)	10/20/2010
Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm	10/21/2010
Invirase (saquinavir): Ongoing safety review of clinical trial data	02/23/2010
Lipitor (atorvastatin) 40 mg: Recall Specific Bottles	12/23/2010
Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events	10/08/2010
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review	01/21/2010
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug	08/16/2010
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug	03/12/2010
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity	11/19/2010
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk	08/20/2010
Zocor (simvastatin): increased risk of muscle injury with high doses	03/19/2010

2009

Product Name	Date Issued/Updated
Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction	11/17/2009
Clopidogrel bisulfate (marketed as Plavix)	01/26/2009
Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)	05/12/2009
Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review	11/20/2009
Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review	07/16/2009
Propafenone HCL Tablets	03/25/2009