Table of Contents - The Medical Letter 2012
May 14, 2012 (Issue 1390)
- Off-Label Use of Ketorolac for Athletic Injuries p. 37
Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into injured muscles, has... - Linagliptin/Metformin (Jentadueto) for Type 2 Diabetes p. 37
Linagliptin (Tradjenta) and metformin (Glucophage, and others) are now available as a fixed-dose combination (Jentadueto – Boehringer Ingelheim/Lilly) for oral treatment of... - Fentanyl Sublingual Spray (Subsys) for Breakthrough Cancer Pain p. 39
The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid...
April 30, 2012 (Issue 1389)
- In Brief: Warning about Drospirenone in Oral Contraceptives p. 33
The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a... - Indacaterol (Arcapta Neohaler) for COPD p. 33
The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta2-agonist, for once-daily maintenance treatment of airflow... - Ingenol Mebutate (Picato) for Actinic Keratoses p. 35
The FDA has approved ingenol mebutate (Picato – Leo) for topical treatment of actinic keratoses (AKs). The new drug is derived from the sap of the Euphorbia peplus plant, a... - Correction: Tafluprost (Zioptan) p. 36
(The Medical Letter 2012; 54:31) In Table 1 on page 31, the formulation column should have included a 0.01% solution of bimatoprost. The size, daily dosage and cost of 0.01% bimatoprost are the same...
April 16, 2012 (Issue 1388)
- Ivacaftor (Kalydeco) for Cystic Fibrosis p. 29
The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D mutation, which is found in... - Transcatheter Aortic-Valve Replacement p. 30
Transcatheter aortic-valve replacement (TAVR), a procedure in which a prosthetic valve is inserted into the aortic annulus by a catheter, has been approved by the FDA as an alternative to surgical... - Tafluprost (Zioptan) - A New Topical Prostaglandin for Glaucoma p. 31
The FDA has approved tafluprost ophthalmic solution (Zioptan – Merck), a prostaglandin analog, for reduction of intraocular pressure in patients with open-angle glaucoma or ocular... - In Brief: Asparaginase Erwinia chrysanthemi (Erwinaze) for ALL p. 32
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia chrysanthemi, for...
April 2, 2012 (Issue 1387)
- Low-Dose Sublingual Zolpidem (Intermezzo) for Insomnia due to Middle-of-the-Night Awakening p. 25
The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due to... - Bupivacaine Liposome Injection (Exparel) for Postsurgical Pain p. 26
The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of postsurgical pain in adults. - Ruxolitinib (Jakafi) for Myelofibrosis p. 27
The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for...
March 19, 2012 (Issue 1386)
- Statin Label Changes p. 21
Citing some recent reports, the FDA has announced changes in the safety labeling of all HMG-CoA reductase inhibitors (statins). - Extended-Release Exenatide (Bydureon) for Type 2 Diabetes p. 21
The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2... - Nitroglycerin Ointment (Rectiv) for Anal Fissure p. 23
The FDA has approved the use of nitroglycerin ointment 0.4% (Rectiv – ProStrakan/Aptalis) for treatment of moderate to severe pain associated with chronic anal fissure; the same drug is... - Clarification: Vitamin E p. 24
The recent Medical Letter article on vitamin supplements1 included 2 sentences on vitamin E that could be misleading. "Vitamin E in food, which is mostly gamma-tocopherol, acts...
March 5, 2012 (Issue 1385)
- Edarbyclor: An ARB/Chlorthalidone Combination for Hypertension p. 17
The FDA has approved a fixed-dose combination of the angiotensin receptor blocker (ARB) azilsartan and the thiazide-like diuretic chlorthalidone as Edarbyclor (Takeda) for treatment of... - Clobazam (Onfi) for Lennox-Gastaut Syndrome p. 18
Clobazam (Onfi – Lundbeck), an oral benzodiazepine, has been approved by the FDA for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years... - Glucarpidase (Voraxaze) for Methotrexate Toxicity p. 19
The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate... - In Brief: Immediate-Release Oxycodone (Oxecta) for Pain p. 20
The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe pain.
Oxecta uses a...
February 20, 2012 (Issue 1384)
- Salt Restriction p. 13
The average daily intake of sodium in the US is about 3400 mg. Dietary guidelines recommend reducing it to <2300 mg/day in general, and to 1500 mg for African Americans, persons with hypertension,... - Zolpidem Oral Spray (Zolpimist) for Insomnia p. 14
Zolpidem oral spray (Zolpimist – NovaDel/ECR), a new formulation of the oral hypnotic zolpidem tartrate (Ambien, and others), has been approved by the FDA for short-term treatment... - Deferiprone (Ferriprox) for Iron Overload p. 15
The FDA has approved deferiprone (de fer’ i prone; Ferriprox– ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload due... - In Brief: 5-HTP for Depression p. 16
A Medical Letter reader asked about the use of the nutritional supplement 5-hydroxytryptophan (5-HTP) for treatment of depression. It is sold in health food stores, pharmacies and on-line for many...
February 6, 2012 (Issue 1383)
- Aflibercept (Eylea) for Age-Related Macular Degeneration p. 9
The FDA has approved aflibercept (a flib’ er sept; Eylea – Regeneron) for treatment of neovascular (wet) age-related macular degeneration (AMD). - PDE5 Inhibitors for Erectile Dysfunction p. 10
Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head comparisons of these... - Crizotinib (Xalkori) for Non-Small Cell Lung Cancer p. 11
The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the... - In Brief: Etonogestrel (Nexplanon) Contraceptive Implant p. 12
Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and...
January 23, 2012 (Issue 1382)
- In Brief: Aliskiren Trial Terminated p. 5
A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or... - Epidural Corticosteroid Injections for Lumbar and Cervical Radiculopathy p. 5
For patients with radicular pain unresponsive to conservative treatment after 1-2 months and no progressive neurologic deficit, epidural corticosteroid injections are often tried before surgical... - Beta-Adrenergic Blockers and Breast Cancer p. 6
Three retrospective studies have recently reported an association between beta-blocker use and a reduction in breast cancer metastasis and recurrence. No prospective, randomized trials have been... - Intranasal Ketorolac (Sprix) p. 7
An intranasal formulation of ketorolac tromethamine (Sprix – Lutipold) has been approved by the FDA for short-term (up to 5 days) treatment of moderate to moderately severe pain in...
January 9, 2012 (Issue 1381)
- Antiviral Drugs for Influenza p. 1
Antiviral drugs can be used for treatment and prophylaxis of influenza. In recent years, the susceptibility of circulating influenza strains has evolved rapidly and treatment recommendations have... - Vandetanib (Caprelsa) for Medullary Thyroid Cancer p. 3
The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with... - In Brief: Ezetimibe/Simvastatin (Vytorin) in Chronic Kidney Disease p. 4
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who...
