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Myfortic (mycophenolic acid)
September 3, 2009
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals. GlaxoSmithKline notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and...
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
August 31, 2009
Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists. [UPDATED 08/31/2009] Supplemental Q&As added [Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor...
Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
August 28, 2009
Audience: Pulmonology healthcare professionals. [UPDATED 08/28/2009] The June 12, 2009 Healthcare Professional Sheet has been updated. FDA provided healthcare professionals with updated information on the original March 2008 early communication and...
Intelence (etravirine)
August 27, 2009
Audience: Infectious disease healthcare professionals, patients. Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There...
Levemir Insulin (Novo Nordisk)
August 26, 2009
Audience: Patients, pharmacists, diabetes healthcare professionals. [UPDATED 08/26/2009]  FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence...
Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]
August 24, 2009
Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals. Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin...
Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
August 24, 2009
Audience: Endocrinological healthcare professionals, patients. FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat...
Steam Dietary Supplement
August 24, 2009
Audience: Consumers, pharmacists. [UPDATED 08/24/2009] Nutracoastal has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction, making Steam an unapproved drug. The lot...
Ibuprofen (Unapproved) topical drug products
August 21, 2009
Audience: Consumers, pharmacists. FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever...
CellCept (mycophenolate mofetil) August 2009
August 14, 2009
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals. Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE...
Dextroamphetamine, Amphetamine 20mg Tablets
August 14, 2009
Audience: Pharmacists, consumers. Dextroamphetamine Saccharate/Amphetamine Aspartate/Dextroamphetamine Sulfate/Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) Barr Laboratories, Inc. issued a voluntary recall of...
GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology
August 13, 2009
Audience: Diabetes healthcare professionals, hospital risk managers, patients. FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ  glucose test strips on patients who are...
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
August 4, 2009
Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists. FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of...
Colchicine (marketed as Colcrys)
July 30, 2009
Audience: Rheumatological healthcare professionals. FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout...
Steam Dietary Supplement
July 29, 2009
Audience: Consumers, pharmacists. Nutracoastal Trading LLC and FDA notified healthcare professionals and consumers of a nationwide recall of the company's dietary supplement product sold under the name Steam. Lab analysis by FDA found that the...
Body Building Products (Marketed as Containing Steroids or Steroid-like Substances)
July 28, 2009
Audience: Consumers and all healthcare professionals. FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as...
Electronic Cigarettes
July 22, 2009
Audience: Pediatric healthcare professionals and consumers. FDA notified healthcare professionals and patients that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene...
Weight Loss Products by Young You Corporation
July 17, 2009
Audience: Consumers, cardiology healthcare professionals. Slimbionic, One Weight Loss Pill, SlimDemand Capsules, Botanical Weight Loss Young You Corporation and FDA notified healthcare professionals and consumers that four weight loss dietary...
Propofol Injectable Emulsion, 10 mg/mL 100 mL vials
July 17, 2009
Audience: Anesthesia healthcare professionals, hospital risk managers. Teva Pharmaceuticals and FDA notified healthcare professionals of a recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The...
Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review
July 16, 2009
Audience: Pediatricians, cardiology, pulmonology healthcare professionals. [07/16/2009] FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in...
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Latest Drug Information Updates

Qutenza
Qutenza is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.

Lysteda
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Pennsaid
Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.

Istodax
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.

Cervarix
Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).

Votrient
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

Arzerra
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

Twynsta
Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.

Berinert
Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Stelara
Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis.

Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Zirgan
Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).

Vibativ
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

Folotyn
Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Valturna
Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.

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