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FDA MedWatch Safety Alerts
Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans
Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
Treanda (bendamustine HCL): Recall - Particulate Matter in Vial
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination
Possibility of an adverse reaction or unknown drug-drug interaction.
Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity
New Boxed Warning and Contraindication highlighting these risks added to product labeling.
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82.
Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient
Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient.
Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles
Particulate matter in injections can be harmful when introduced into the bloodstream.
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk
A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.
Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps
Consumers are asked to either destroy or return unused product identified in the recall to Novartis.
Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings
Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation
Ventilator may stop ventilating and result in life-threatening injury or death.
Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors
Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.
Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
ShoulderFlex Massager: Warning - Risk of Strangulation
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation
Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.