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FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines
The U.S. Food and Drug Administration (FDA) has approved a risk management plan for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines. TIRF medicines contain fentanyl, a prescription opioid (narcotic) pain reliever and are formulated in sublingual or buccal tablets, lonzenges, and nasal sprays for immediate release. TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain. The current list of TIRF medicines include: Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal. This risk management plan, called the TIRF REMS Access program, consists of a restricted distribution program to reduce the risk of misuse, abuse, addiction, and overdose with TIRF medicines. The TIRF REMS Access program will replace the risk management plans and programs that are currently in place for each individual TIRF medicine. The FDA does not expect that this new class Risk Evaluation and Mitigation Strategy (REMS) will affect patient access to TIRF medicines. The TIRF REMS Access Program will begin in March 2012. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm
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FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral
The Food and Drug Administration (FDA) has expanded a recent recall of supplements from Purity First Health Products Inc. The recall now includes certain lots of the supplement-maker’s Vitamin C and Multi-Mineral products. The following products have been recalled because they have been found to contain anabolic steroids: • Healthy Life Chemistry B-50, 100 capsule bottles, lot numbers F03Q and C02R • Healthy Life Chemistry Multi-Mineral, 200 capsule bottles, lot number 12-829 • Healthy Life Chemistry Vitamin C, 200 capsule bottles, lot number E03Q These products are sold as dietary supplements packaged in white plastic bottles and are available on various websites and in retail stores. The B-50 capsules were tested by the FDA and have been found to contain Methasterone (a schedule III controlled substance) and Dimethazine. The Multi-Mineral and Vitamin C capsules appear to indicate the presence of Dimethyltestosterone which is an unapproved anabolic steroid. These steroid-contaminated B-50, Multi-Mineral and Vitamin C capsules potentially could result in the following serious side effects: liver injury, increased blood cholesterol levels, increased risk of heart attack and stroke, masculinization of women, shrinkage of the testicles, breast enlargement, infertility in males, and short stature in children. More common side effects include fatigue, muscle cramping, and muscle pain. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm363374.htm
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Date Published Title Drug Source
2012-01-02 FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines Fentanyl FDA
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA
2011-08-03 FDA Warns: Risk of Birth Defect with Long-Term, High-Dose Fluconazole During Pregnancy Fluconazole FDA
2009-08-27 Galantamine (Razadyne) Linked to Increased Risk of Fainting and Low Heart Rate Galantamine MediGuard CRT
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Aspart FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Glargine FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Lispro FDA
2008-11-10 New Safety Information about Long-term Use of Ipratropium for COPD Albuterol Sulfate with Ipratropium Bromide MediGuard CRT
2009-11-14 Possible Contamination of Cerezyme Imiglucerase FDA
2009-11-20 Recall of Several Lots of Brompheniramine Tannate Suspension Brompheniramine FDA
2009-01-14 Update on FDA Safety Review Zileuton FDA
2010-08-11 2010-2011 Flu Vaccine: What Consumers Should Know Influenza Vaccine FDA
2010-10-08 Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia Sibutramine FDA
2011-05-02 Abbott Laboratories Recalls Select Lots of Humira (adalimumab) Pen, 40 mg/0.8mL Adalimumab FDA
2011-04-25 Abbott Laboratories Recalls Several Lots of CREON (pancrelipase) Delayed Release Capsules, 6000 USP units Creon 20 FDA
2013-01-14 Abbott Laboratories Recalls Single Lot of Synthroid tablets, 150 mcg Levothyroxine FDA
2010-09-27 Abbott Voluntarily Recalls Certain Similac Brand Powder Infant Formulas That Did Not Meet Quality Standards Manufacturer
2011-08-27 Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa) Citalopram FDA
2010-12-14 Accidental Ingestion of Benzonatate (Tessalon) By Children Can Result in Serious Adverse Effects Benzonatate FDA
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