bad medical devices blog

Latest Medical Device News

• Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity - New Boxed Warning and Contraindication highlighting these risks added to product labeling.
• 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.
• 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.
• CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation - Ventilator may stop ventilating and result in life-threatening injury or death.
• 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.
• 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.
• Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose - Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
• 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.
• 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.
• Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events - UPDATED 12/19/2011. FDA completed safety review, issued new recommendations. Originally posted 07/21/2011
• 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.
• November 2011 - Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.
• 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.
• 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.
• Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn - Conflicting results from different studies makes it premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.
• 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.
• 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.
• Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination - Possibility of an adverse reaction or unknown drug-drug interaction.
• Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations - [UPDATED 12/15/2011] FDA revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. Originally posted 06/08/2011