Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
Audience: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. Posting this information does not mean... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 26, 2013 Category: Drugs & Pharmacology Source Type: news
Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient
Audience: Consumer ISSUE: Olaax Corp announced a nationwide recall of the company's dietary supplement sold under the brand name Maxiloss Weight Advanced Softgels to the user level, because FDA testing found the Maxiloss Weight Advanced product to... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 25, 2013 Category: Drugs & Pharmacology Source Type: news
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions
Audience: Patients, Healthcare Professionals, Nephrology, Hematology ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 23, 2013 Category: Drugs & Pharmacology Source Type: news
Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death
Audience: Pediatricians, Surgery, Consumer [UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Reumofan Plus: Recall - Undeclared Drug Ingredient
[UPDATED 2/19/2013]
Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. The... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 19, 2013 Category: Drugs & Pharmacology Source Type: news
Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter
Audience: Pharmacy, Patient, Health Professional ISSUE: Gilead Sciences, Inc. is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 16, 2013 Category: Drugs & Pharmacology Source Type: news
Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk
Audience: Consumer, Patient, Surgery ISSUE: R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 4, 2013 Category: Drugs & Pharmacology Source Type: news
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility
[Posted 01/28/2013]
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - January 28, 2013 Category: Drugs & Pharmacology Source Type: news
Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
Audience: Gastroenterology, Nephrology, Pharmacy
[Posted 01/25/2013]
ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - January 25, 2013 Category: Drugs & Pharmacology Source Type: news
Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets
Audience: Pharmacy, Consumer ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - January 18, 2013 Category: Drugs & Pharmacology Source Type: news
Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
Audience: Family Practice, Health Professional, Patient Including Ambien, Ambien CR, Edluar, and Zolpimist
[Posted 01/10/2013]
ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug.... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - January 10, 2013 Category: Drugs & Pharmacology Source Type: news
Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile
Audience: Ophthalmology ISSUE: Mobius Therapeutics announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company cannot exclude the possibility that the affected... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - January 10, 2013 Category: Drugs & Pharmacology Source Type: news
