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Friday September 10, 2010

Posts Tagged ‘Dangerous Drugs’

Tygacil (tigecycline): Label Change – Increased Mortality Risk

Tuesday, August 31st, 2010

Audience: Infectious Disease, Critical Care Medicine, Internal Medicine ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of…



Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal – Risk of Thromboembolic Events

Tuesday, August 24th, 2010

Audience: Risk Manager, Hematology, Pharmacy
ISSUE: Octapharma USA Inc. initiated a voluntary market withdrawal of selected lots of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation as a result of an increased number of reported…



MasXtreme Capsules (Natural Wellness) – product contains undeclared drug ingredient

Tuesday, August 24th, 2010

Audience: Consumers, Pharmacists [UPDATED 08/25/2010] Natural Wellness notified consumers it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA determined the product…



TimeOut Capsules: Undeclared Drug Ingredient

Tuesday, August 24th, 2010

Audience: Consumers ISSUE:  FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs…



Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

Thursday, August 19th, 2010

Audience: Neurology, Cardiology Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for…



Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

Sunday, August 15th, 2010

Audience: Cardiology and Nephrology ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval studies that verify the…



Prolatis’: Undeclared Drug Ingredient

Thursday, August 12th, 2010

Audience: Consumers [Posted 08/13/2010]

ISSUE: Lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an…



Lamictal (lamotrigine): Label Change – Risk of Aseptic Meningitis

Wednesday, August 11th, 2010

Audience: Pediatrics, Neurology, Psychiatry ISSUE: FDA notified healthcare professionals and patients that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause…



Novacare LLC Products: Recall – Undeclared Drug Ingredient

Tuesday, August 10th, 2010

Audience: Consumers Products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45,…



Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy – Risk of serious hematological reactions

Tuesday, August 3rd, 2010

Audience: Primary Care, Infectious Disease
[UPDATED 08/04/2010] Dear Healthcare Professional Letter issued.
[Posted 07/08/2010]
ISSUE: Due to continued reports of serious side effects in patients using Qualaquin “off-label” for night time leg…



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