Drugs.com FDA MedWatch Alerts

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: 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...

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....

Audience: Neurosurgery, Anesthesia, Risk Manager ISSUE: FDA reminded healthcare professionals that oral nimodipine capsules should be given only by mouth or through a feeding or nasogastric tube and should never be given by intravenous...

Audience: Consumer ISSUE: FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient...

Audience: Consumers, Emergency Medicine ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as...

Audience: Pediatrics, Family Practice ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence...

Audience: Infectious Disease, Pulmonology ISSUE:  FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug...

Audience: OB/GYN, Patient Keep Kids, Pets Away From Skin Sprayed With Evamist - FDA Consumer Update ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen...