2013 Drug Safety Communications

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• FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing 12/20/2013
• FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes 12/17/2013
• FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes 12/3/2013
• FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines 11/25/2013
• FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine) 11/20/2013
• FDA requests label changes and single-use packaging for over-the-counter topical antiseptic products to decrease risk of infection 11/13/2013
• Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins 11/06/2013
• FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales 11/05/2013
• FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration 10/31/2013
• FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales 11/05/2013
• FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins 10/11/2013
• FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning 09/27/2013
• Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) 09/25/2013
• FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety-emphasizing that accidental exposure to used patches can cause death 09/23/2013
• FDA investigating rare brain infection in patient taking Gilenya (fingolimod) 08/29/2013
• FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection 08/15/2013
• FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen 08/01/2013
• FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects 07/29/2013
• FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems 07/26/2013
• FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil 07/03/2013
• FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) 06/18/2013
• FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies 05/30/2013
• FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR 05/14/2013
• FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children 05/06/2013
• FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) 05/06/2013
• FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death 04/30/2013
• Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration 04/26/2014
• FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes 03/14/2013
• FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms 03/12/2013
• FDA Drug Safety Communication: FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death 02/26/2013
• FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy 02/20/2013
• Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) 01/10/2013