Safety Alerts & Recalls

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Latest Alerts

New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers
The FDA is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the Boxed Warning in the prescribing information to warn of an increased risk of lymphoma and other cancers in children and adolescents treated with TNF blockers. This new Boxed Warning is an addition to the existing Boxed Warning relating to the risk of potentially fatal infections, including tuberculosis, in all patients who use TNF blockers. The currently FDA approved TNF blockers include adalizumab (marketed as Humira), certolizumab (marketed Cimzia), etanercept (marketed Enbrel), golimumab (marketed as Simponi), and infliximab (marketed as Remicade). TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis. In addition to the updated Boxed Warning, the FDA is requiring several other changes to the prescribing information for TNF blockers, including: 1) An update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children 2) An update to the Adverse Events section to include information on reported cases of new-onset psoriasis 3) An update to the Medication Guide for these medications to provide this new safety information to patients who receive prescriptions for TNF blockers This new safety information is based on the FDA's completed analysis of TNF blockers which included reports of lymphoma and other cancers in children and adolescents, post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm
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Recall of Four Lots of Humira Pen Psoriasis Starter Package
Abbott Laboratories has issued a voluntary recall of several lots of Humira (adalimumab) Pen Psoriasis Starter Package with 4 single use prefilled pens of Humira for subcutaneous use only, 40 mg/0.8mL. The following lots and expiration dates (Exp) are being recalled because the some of the Humira Psoriasis Starter Packages may have been mispackaged with the pens placed within the carton in way that does not follow the recommended initial dosing directions: Lot # 70266SP44, Exp SEP 2010 Lot # 74329SP41, Exp JAN 2011 Lot # 74329SP42, Exp JAN 2011 Lot # 74329SP45, Exp JAN 2011 Humira contains the active ingredient adalimumab and is used in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, anklyosing spondylitis, Crohn's disease, and psoriasis. Humira is dispensed in several different types of packages. This recall only applies to four specific lots of Humira Pen 40 mg/0.8 mLin the Psoriasis Starter Package. For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm204085.htm
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Date Published Title Drug Source
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Adalimumab FDA
2010-04-02 Recall of Four Lots of Humira Pen Psoriasis Starter Package Adalimumab FDA
2011-05-02 Abbott Laboratories Recalls Select Lots of Humira (adalimumab) Pen, 40 mg/0.8mL Adalimumab FDA
2013-11-21 FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine) Adenosine FDA
2009-11-14 Possible Contamination of Fabrazyme Agalsidase Beta FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2008-05-30 CFC to HFA transition advisory Albuterol FDA
2008-12-19 Reminder: CFC to HFA Inhaler Transition Albuterol FDA
2009-09-17 Several Lots of Albuterol Sulfate Inhalation Solution, 0.083% Reported Stolen Albuterol Manufacturer
2011-01-03 Recall - Mislabeled Unit Dose Vials Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Albuterol FDA
2011-01-10 Teva Pharmaceuticals Inc. Recalls Several Lots of ProAir HFA Albuterol FDA
2012-03-07 GlaxoSmithKline Inc. Recalls Several Lots of Ventolin HFA (Albuterol Sulfate) 90 mcg Albuterol FDA
2012-09-17 GlaxoSmithKline Recalls Several Lots of Ventolin HFA Inhaler Albuterol FDA
2012-10-08 Nephron Pharmaceuticals Corporation Recalls Select Lots of Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Vials Albuterol FDA
2013-10-18 Nephron Pharmaceuticals Announces Recall of Albuterol Sulfate Inhalation Solution, 0.083% Albuterol FDA
2008-11-10 New Safety Information about Long-term Use of Ipratropium for COPD Albuterol Sulfate with Ipratropium Bromide MediGuard CRT
2010-04-15 Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available Albuterol Sulfate with Ipratropium Bromide FDA
2011-03-05 Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05% Alclometasone FDA
2007-10-01 Early communication of ongoing safety review Alendronate FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Alendronate FDA
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