Drugs.com FDA MedWatch Alerts

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Latest alerts to consumers and health care providers warning of recently identified adverse effects associated with currently available drugs and supplements.
Updated: 1 hour 26 min ago

Tygacil (tigecycline): Label Change - Increased Mortality Risk

Wed, 2010-09-01 00:00
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...


Categories: Medical Feeds

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

Wed, 2010-08-25 00:00
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...


Categories: Medical Feeds

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

Wed, 2010-08-25 00:00
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...


Categories: Medical Feeds

TimeOut Capsules: Undeclared Drug Ingredient

Wed, 2010-08-25 00:00
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...


Categories: Medical Feeds

Mr. Magic Male Enhancer: Undeclared Drug Ingredient

Tue, 2010-08-24 00:00
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...


Categories: Medical Feeds

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

Fri, 2010-08-20 00:00
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...


Categories: Medical Feeds

Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

Mon, 2010-08-16 00:00
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...


Categories: Medical Feeds

Prolatis': Undeclared Drug Ingredient

Fri, 2010-08-13 00:00
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...


Categories: Medical Feeds

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

Thu, 2010-08-12 00:00
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...


Categories: Medical Feeds

Novacare LLC Products: Recall - Undeclared Drug Ingredient

Wed, 2010-08-11 00:00
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,...


Categories: Medical Feeds

Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient

Mon, 2010-08-09 00:00
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...


Categories: Medical Feeds

Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient

Mon, 2010-08-09 00:00
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...


Categories: Medical Feeds

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

Wed, 2010-08-04 00:00
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...


Categories: Medical Feeds

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

Mon, 2010-08-02 00:00
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....


Categories: Medical Feeds

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Mon, 2010-08-02 00:00
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...


Categories: Medical Feeds

Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

Fri, 2010-07-30 00:00
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...


Categories: Medical Feeds

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

Fri, 2010-07-30 00:00
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...


Categories: Medical Feeds

Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

Fri, 2010-07-30 00:00
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...


Categories: Medical Feeds

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Thu, 2010-07-29 00:00
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...


Categories: Medical Feeds

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Thu, 2010-07-29 00:00
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...


Categories: Medical Feeds