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…
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…
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…
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…
Audience: Consumers
ISSUE: Lab analysis has found Mr. Magic to contain hydroxythiohomosildenafil and sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making the product an…
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…
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…
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…
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…
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…
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,…
Audience: Consumer
ISSUE: FDA lab analysis of Revivexxx Extra Strength was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx Extra Strength an unapproved…
Audience: Cardiology, Consumer ISSUE: FDA lab analysis of Solo Slim was found to contain the undeclared drug ingredient Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. This poses a threat…
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…
Audience: Cardiovascular Surgery, Anesthesia, Pharmacy
ISSUE: FDA notified healthcare professionals of a recall of two lots of NeoProfen (ibuprofen lysine) Injection because the product failed to meet a visible particulate quality requirement….
