Acetylcysteine Inhalation Solution Acyclovir Sodium Injection (initial posting 11/13/2012)  Alteplase (Cathflo Activase) (initial posting 1/27/2012) Amikacin Injection  7/22/2013Aminocaproic Acid Injection (initial posting 3/8/2013)  Aminophylline (initial posting 12/10/2012) Ammonium Chloride Injection (initial posting 3/8/2013) Amytal Sodium Injection (initial posting date 1/31/2013) Atracurium Besylate (initial posting 2/27/2012) Atropine Sulfate Injection  back to top Bacteriostatic 0.9% Sodium Chloride (initial posting 9/10/2012) Barium Sulfate for Suspension (initial posting 10/12/2012)  7/28/2013Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride (Helidac) (initial posting…
FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects
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FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
Safety Announcement [7-26-2013]   The U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes…
June 2013: Additions and Deletions to the Drug Product List (PDF)
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FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil
Data Summary Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) that was approved on April 25, 2002, for the treatment of hypertension, alone or with other antihypertensive agents. The current olmesartan drug labels include diarrhea in the Adverse Reactions section. FDA evaluated adverse event reports received by FDA’s Adverse Event Reporting System (FAERS), published…
FDA Drug Safety Communication: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate)
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May 2013: Additions and Deletions to the Drug Product List
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FDA Adverse Event Reporting System (FAERS) Statistics
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Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination
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CDERLearn
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