FDA MedWatch Alerts

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November 20, 2008
Audience: Consumers, endocrinological healthcare professionals [Posted 11/20/2008] Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020...
November 17, 2008
Audience: Consumers, dermatologists, pharmacists, other healthcare professionals[Posted 11/17/2008] CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne...
November 12, 2008
Audience: Consumers, pediatricians, other healthcare professionals[Posted 11/12/2008] Johnson & Johnson, Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas...
November 12, 2008
Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals[Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients...
November 10, 2008
Audience: Pharmacists, other healthcare professionals, patients [Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release...
November 6, 2008
Audience: Patients with insulin-dependent diabetes; pharmacists[Posted 11/06/2008] Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed...
October 17, 2008
Audience: Dermatological healthcare professionals, patients[Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial...
October 16, 2008
Audience: Pharmacists, other healthcare professionals, patients[Posted 10/16/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the...
October 9, 2008
Audience: Pediatric and primary healthcare professionals, consumers [Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for...
October 7, 2008
Audience: Pulmonary care health professionals and patients[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a...
October 3, 2008
Audience: Healthcare professionals, consumers [Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could...
October 2, 2008
Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers [Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic...
September 30, 2008
Audience: Neurologists, cardiologists, consumers[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as...
September 26, 2008
Audience: Neurological healthcare professionalsPosted 09/23/2008] FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical...
September 23, 2008
Audience: Oncological healthcare professionals[Posted 09/23/2008] OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva,...
September 23, 2008
Audience: Hospital ER and ICU medical and nursing personnel, risk managersPosted 09/23/2008] Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may...
September 22, 2008
Audience: Consumers, pediatricians [UPDATE 09/22/2008] FDA contacted companies who manufacture infant formula for distribution in the United States and has learned that they are not importing formula or source materials from China. FDA, in...
September 18, 2008
Audience: Oncologists, other healthcare professionals[Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the...
September 16, 2008
Audience: Emergency medical personnel, other healthcare professionals [Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in...
September 12, 2008
Audience: Consumers, pediatricians, other healthcare professionals [Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese...
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MedNotes
Latest Drug Information Updates

Apriso
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

LoSeasonique
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Acanya
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

Toviaz
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Vimpat
Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

Astepro
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

Rapaflo
Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

Cinryze
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Akten
Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

AdreView
AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

Sancuso
Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

Nplate
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Xenazine
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

Cleviprex
Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

Stavzor
Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

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