Table of Contents - The Medical Letter 2010
January 11, 2010 (Issue 1329)
- Telavancin (Vibativ) for Gram-Positive Skin Infections p. 1
Telavancin (Vibativ - Astellas and Theravance), a lipoglycopeptide derivative of vancomycin (Vancocin, and others), has received FDA approval for treatment of complicated skin and skin... - A Third Amlodipine/ARB Combination (Twynsta) for Hypertension p. 2
The FDA has approved Twynsta (Boehringer Ingelheim), a fixed-dose combination of the calcium-channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) telmisartan, for... - Intravenous Ibuprofen (Caldolor) p. 3
An intraveneous (IV) formulation of ibuprofen (Caldolor - Cumberland) was recently approved by the FDA for use in adults. It can be administered alone for treatment of mild to moderate pain or...
January 25, 2010 (Issue 1330)
- Medical Marijuana p. 5
Fourteen states in the US - Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington - now permit, or soon will... - Glucose Control in the ICU p. 6
Once thought to be a beneficial response to critical illness, hyperglycemia is now recognized as independently associated with death and other adverse outcomes in various groups of critically ill... - Ustekinumab (Stelara) for Psoriasis p. 7
The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe...
February 8, 2010 (Issue 1331)
- Asenapine (Saphris) Sublingual Tablets for Schizophrenia and Bipolar Disorder p. 9
Asenapine (Saphris - Schering-Plough), a dibenzo-oxepino pyrrole, has been approved by the FDA in a sublingual tablet formulation for acute treatment of schizophrenia and manic or mixed... - Topical Oxybutynin (Gelnique) for Overactive Bladder p. 10
The FDA has approved the marketing of a 10% topical gel formulation of the muscarinic receptor antagonist oxybutynin chloride (Gelnique - Watson) for treatment of overactive bladder.... - Bepotastine (Bepreve) - An Ophthalmic H1-Antihistamine p. 11
Bepotastine besilate 1.5% ophthalmic solution (Bepreve - ISTA Pharmaceuticals), an H1-antihistamine, has been approved by the FDA for topical treatment of itching associated with...
February 22, 2010 (Issue 1332)
- Iloperidone (Fanapt) - Another Second-Generation Antipsychotic p. 13
The FDA has approved the marketing of iloperidone (Fanapt – Vanda), a second-generation antipsychotic, for treatment of schizophrenia. Iloperidone is chemically related to risperidone... - Vigabatrin (Sabril) for Epilepsy p. 14
The FDA has approved vigabatrin (vye gá ba trin; Sabril – Lundbeck) for oral use as add-on therapy for complex partial seizures in adults who are refractory to several antiepileptic drugs...
March 8, 2010 (Issue 1333)
- Rosiglitazone (Avandia) Revisited p. 17
The cardiovascular safety of the thiazolidinedione rosiglitazone (Avandia – GlaxoSmithKline) is in the news again, with some authorities calling for its removal from the market (New York... - Primary Prevention of Ulcers in Patients Taking Aspirin or NSAIDs p. 17
Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are common causes of peptic ulcer disease. Patients infected with Helicobacter pylori who take aspirin or another NSAID have... - Hyperbaric Oxygen Therapy for Refractory Wounds p. 19
Hyperbaric oxygen (HBO2) therapy, breathing 100% O2 while exposed to increased atmospheric pressure, has been used for years to treat refractory wounds, especially diabetic foot... - Addendum: Cost of Ustekinumab (Stelara) p. 20
In the Medical Letter article on ustekinumab (Stelara) for psoriasis (2010; 52:7), footnote 2 in table 2 should have included a second sentence: $5595.60 is...
March 22, 2010 (Issue 1334)
- In Brief: Stopping Long-Acting Beta-2 Agonists p. 21
A little more than a year ago, The Medical Letter reported the results of an FDA meta-analysis which found that use of a long-acting beta-2 agonist (LABA) such as salmeterol (Severent) or... - A Morphine/Naltrexone Combination (Embeda) for Pain p. 22
The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for... - Ferumoxytol (Feraheme) - A New Parenteral Iron Formulation p. 23
Ferumoxytol (Fer yoo mox’ i tole; Feraheme – AMAG), an intravenous (IV) iron replacement product, has been approved by the FDA for treatment of iron deficiency anemia in adults with... - Combination Oral Contraceptives and the Risk of Venous Thromboembolism p. 23
Combination oral contraceptives increase the risk of venous thromboembolism (VTE). Their benefits, in addition to preventing pregnancy, include lowering the risk of ovarian and endometrial cancer,...
April 5, 2010 (Issue 1335)
- Liraglutide (Victoza) for Type 2 Diabetes p. 25
Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2... - Plerixafor (Mozobil) p. 27
The FDA has approved plerixafor (Mozobil – Genzyme), a CXCR4 chemokine receptor antagonist, for use in combination with granulocyte-colony stimulating factor (G-CSF; Neupogen) to...
April 19, 2010 (Issue 1336)
- Dutasteride (Avodart) for Prevention of Prostate Cancer p. 29
A study recently published in the New England Journal of Medicine concluded that dutasteride (Avodart – GlaxoSmithKline), a 5α-reductase inhibitor marketed for treatment of... - Edluar - A New Sublingual Formulation of Zolpidem p. 29
Edluar (Meda), a new sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem (Ambien, and others), has been approved by the FDA for treatment of insomnia. - Fentanyl Buccal Soluble Film (Onsolis) for Breakthrough Cancer Pain p. 30
Fentanyl buccal soluble film (Onsolis – Meda) has been approved by the FDA for treatment of breakthrough pain in adult cancer patients who are already taking and are tolerant to... - L-Methylfolate (Deplin) for Depression and Schizophrenia p. 31
L-methylfolate (Deplin — Pamlab) is a “medical food” marketed for adjunctive use in depression or schizophrenia in patients with suboptimal folate levels. It is available only by... - Correction: Ferumoxytol (Feraheme) p. 32
In the Medical Letter article on Ferumoxytol (Feraheme) - A New Parenteral Iron Formulation (2010; 52:23), the last sentence of the Dosage,...
May 3, 2010 (Issue 1337)
- In Brief: Poor Metabolizers of Clopidogrel (Plavix) p. 33
The FDA has required the manufacturer of Plavix, an antiplatelet drug used in addition to aspirin to prevent cardiovascular events in high-risk patients,1 to add a... - Everolimus and Pazopanib: Two New Drugs for Renal Cell Cancer p. 33
Everolimus (Afinitor – Novartis) and pazopanib (Votrient – GlaxoSmithKline), two oral multikinase inhibitors, have been approved by the FDA for treatment of advanced renal cell... - Cost of Topical Products for Tinea Pedis p. 35
A Medical Letter reader recently received a diagnosis of athlete’s foot and a prescription for Naftin gel, for which his pharmacy charged $145, and his insurance company required a $70 copay... - In Brief: Velaglucerase (Vpriv) for Gaucher's Disease p. 36
The FDA has approved velaglucerase alfa (Vpriv – Shire), a new formulation of glucocerebrosidase prepared from human fibroblasts, for treatment of the nonneurologic form of Gaucher’s...
May 17, 2010 (Issue 1338)
- Cervarix - A Second HPV Vaccine p. 37
The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18,... - Which TNF Inhibitor for Rheumatoid Arthritis? p. 38
The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the... - Another Once-Daily Formulation of Tramadol (Ryzolt) p. 39
The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in...
May 31, 2010 (Issue 1339)
- In Brief: Herpes Zoster Vaccine (Zostavax) Revisited p. 41
The 2006 Medical Letter article on the then-new varicella-zoster vaccine concluded that Zostavax appears to be safe and effective in protecting patients ≥60 years old against herpes zoster... - Safety of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD) p. 41
Two combinations of an inhaled corticosteroid with an inhaled long-acting beta2-agonist are approved by the FDA for use in patients with COPD: fluticasone/salmeterol (Advair Diskus) and... - Romidepsin (Istodax) for Cutaneous T-Cell Lymphoma p. 42
The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one... - Bioidentical Hormones p. 43
In recent years, many women have become concerned about the safety of pharmaceutical replacement hormones for treatment of menopausal symptoms. “Bioidentical” hormone preparations, which are not...
June 14, 2010 (Issue 1340)
- Robotic-Assisted Laparoscopic Surgery p. 45
The da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA) has become available in recent years for use in laparoscopic prostatectomy, gynecological procedures, general surgery,... - A Plasma-derived Von Willebrand Factor/Factor VIII Concentrate (Wilate) p. 46
The FDA has approved a new plasma-derived von Willebrand factor/Factor VIII concentrate (Wilate – Octapharma) for treatment of spontaneous and trauma-induced bleeding episodes in patients... - Tocilizumab (Actemra) for Rheumatoid Arthritis p. 47
The FDA has approved tocilizumab (Actemra – Genentech; RoActemra in Europe) for intravenous (IV) treatment of adult patients with moderately to severely active rheumatoid arthritis...
June 28, 2010 (Issue 1341)
- In Brief: Only The Name Remains The Same p. 49
A Medical Letter subscriber was surprised to discover that a new Citracal product contained not only calcium citrate, but also calcium carbonate. Citracal Plus Bone Density Builder... - Preservation of Ovarian Function During Chemotherapy p. 49
Chemotherapy can result in premature menopause and infertility in young women. Pretreatment fertility counseling followed by appropriate action may prevent some of these undesirable consequences. - A Sumatriptan Needle-Free Injector for Migraine p. 50
Sumatriptan was first marketed in the US in 1993 as Imitrex for subcutaneous injection, followed by tablets for oral administration and then by a nasal spray. It is one of seven serotonin... - Ofatumumab (Arzerra) for CLL p. 51
The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to...
July 12, 2010 (Issue 1342)
- Treatment of Lyme Disease p. 53
Most cases of Lyme disease in the US occur between May and September in the Northeastern, Mid-Atlantic and North Central states. - Tranexamic Acid (Lysteda) for Treatment of Menorrhagia p. 54
The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for... - Pralatrexate (Folotyn) for Peripheral T-Cell Lymphoma p. 55
The FDA has approved pralatrexate (Folotyn – Allos), an intravenous (IV) antifolate, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the first... - Correction: A Sumatriptan Needle-Free Injection for Migraine p. 56
In The Medical Letter article on Sumatriptan Needle-Free Injection for Migraine (2010; 52:50), on page 51, in Table 2, the injection volumes of...
July 26, 2010 (Issue 1343)
- Pitavastatin (Livalo) - The Seventh Statin p. 59
The FDA has approved the marketing of pitavastatin (Livalo – Kowa), an HMG-CoA reductase inhibitor (“statin”), for treatment of primary hyperlipidemia or mixed dyslipidemia. It has been... - A New Conjugate Meningococcal Vaccine (Menveo) p. 59
The FDA has approved Menveo (Novartis), a new quadrivalent conjugated polysaccharide vaccine, for protection against disease caused by Neisseria meningitidis in people 11-55 years old.
August 9, 2010 (Issue 1344)
- Armodafinil (Nuvigil) for Wakefulness p. 61
Armodafinil (Nuvigil – Cephalon), the R-enantiomer of the non-amphetamine stimulant modafinil (Provigil – Cephalon; Alertec – Shire in Canada), is being promoted directly... - Nutritional Support for Macular Degeneration p. 63
An advertisement in a recent issue of Ophthalmology introduces PreserVision Eye Vitamin AREDS 2 Formula from Bausch & Lomb. No specific indication is mentioned, but the ad... - Aztreonam for Inhalation Solution (Cayston) for Cystic Fibrosis p. 63
The antibiotic aztreonam is now available as an inhalation solution (Cayston – Gilead) to improve respiratory symptoms in cystic fibrosis (CF) patients ≥7 years old colonized with... - Correction: Pitavastatin (Livalo) - The Seventh Statin p. 64
In issue 1343, the usual decrease in LDL-cholesterol with pitavastatin (Livalo) in the table on page 58 should have been 35-40% with 2 mg and...
August 23, 2010 (Issue 1345)
- Bronchial Thermoplasty for Asthma p. 65
The FDA has approved the marketing of the Alair Bronchial Thermoplasty System (Asthmatx) for treatment of severe persistent asthma in patients ≥18 years old whose asthma is not well... - Three New Drugs for Hereditary Angioedema p. 66
In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for... - An Expanded Pneumococcal Vaccine (Prevnar 13) for Infants and Children p. 67
The FDA has licensed a 13-valent conjugate pneumococcal vaccine (PCV13; Prevnar 13 – Pfizer) for the prevention of invasive pneumococcal disease (IPD) in infants and children <6 years old....
September 6, 2010 (Issue 1346)
- In Brief: Propoxyphene Toxicity p. 69
The FDA has required manufacturers of propoxyphene-containing products (Darvon, and others) to strengthen boxed warnings to include the potential for overdose.1 This... - New Treatments for Metastatic Prostate Cancer p. 69
The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved... - Tribenzor for Hypertension p. 70
Many patients with hypertension require more than one drug to control their blood pressure. Tribenzor (Daiichi Sankyo), recently approved by the FDA for treatment of hypertension, combines the... - Natazia - A New Oral Contraceptive p. 71
The FDA has approved the marketing of Natazia (Bayer), a 4-phase oral contraceptive containing the estrogen estradiol valerate and the progestin dienogest, both used for the first time in the...
September 20, 2010 (Issue 1347)
- Dalfampridine (Ampyra) for MS p. 73
The FDA has approved the use of dalfampridine (4-aminopyridine; Ampyra – Acorda), a potassium channel blocker, to improve walking speed in patients with multiple sclerosis (MS). Walking... - Naproxen/Esomeprazole (Vimovo) p. 74
The FDA has approved the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI)... - Nonstandard Uses of Chelation Therapy p. 75
Chelation therapy involves oral administration, intravenous infusion or intramuscular injection of drugs that increase excretion of heavy metals. The Medical Letter’s last article on this...
October 4, 2010 (Issue 1348)
- Seasonal Trivalent Influenza Vaccine for 2010-2011 p. 77
Superseded by The Medical Letter "Influenza Vaccine for 2011-2012" - Issue 1375, October 17, 2011
Annual vaccination against influenza A and B viruses... - Low-Dose Doxepin (Silenor) for Insomnia p. 79
The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer... - In Brief: Recommendation for Earlier Antibiotic Prophylaxis for Cesarean Delivery p. 80
The American Congress of Obstetricians and Gynecologists (ACOG) has announced a new recommendation for antibiotic prophylaxis during cesarean delivery.1 Currently most women...
October 18, 2010 (Issue 1349)
- Denosumab (Prolia) for Postmenopausal Osteoporosis p. 81
The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture. - Guanfacine Extended-Release (Intuniv) for ADHD p. 82
An extended-release oral formulation of guanfacine hydrochloride (Intuniv – Shire), a selective alpha2A-adrenergic agonist, has been approved by the FDA for treatment of... - Mometasone/Formoterol (Dulera) for Asthma p. 83
A combination of the corticosteroid mometasone furoate (Asmanex) and the long-acting beta2-agonist (LABA) formoterol (Foradil) has become available in a single metered-dose...
November 1, 2010 (Issue 1350)
- Desirudin (Iprivask) for DVT Prevention p. 85
The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of... - Interferon Beta-1b (Extavia) for Multiple Sclerosis p. 86
The FDA has approved a new interferon beta-1b product (Extavia – Novartis) for treatment of relapsing forms of multiple sclerosis (MS). Extavia is identical to Betaseron... - Rifaximin (Xifaxan 550) for Hepatic Encephalopathy p. 87
The FDA has approved a new 550-mg tablet of rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic, to reduce the risk of recurrent hepatic encephalopathy (HE). A 200-mg tablet... - In Brief: Sibutramine (Meridia) Withdrawn p. 88
The results of a postmarketing study of its cardiovascular safety have led to the removal of the weightloss drug sibutramine (Meridia) from the market in the US and Canada. It has also been... - In Brief: Safety of Quinine p. 88
Qualaquin, the only formulation of quinine sulfate available in the US, is approved only for treatment of uncomplicated malaria, but most prescriptions for its use are written for treatment...
November 15, 2010 (Issue 1351)
- Dabigatran Etexilate (Pradaxa) - A New Oral Anticoagulant p. 89
The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with... - A New Botulinum Toxin (Xeomin) for Cervical Dystonia and Blepharospasm p. 90
The FDA has approved incobotulinumtoxinA (Xeomin – Merz) for treatment of cervical dystonia and blepharospasm in adults. It has been commercially available in Germany since 2005. Several... - Extended-Release Trazodone (Oleptro) for Depression p. 91
The FDA has approved the marketing of an extended-release formulation of trazodone (Oleptro – Angelini Labopharm) for treatment of major depressive disorder in adults. Immediate-release... - Correction: Mometasone/Formoterol (Dulera) for Asthma p. 92
(Med Lett Drugs Ther 2010; 52:83) The second clinical trial described under the paragraph heading “Clinical Studies” compared the 2 different...
November 29, 2010 (Issue 1352)
- In Brief: Clopidogrel and Omeprazole p. 93
Use of a proton pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding in patients taking the antiplatelet agent clopidogrel (Plavix) may interfere with the activation of... - Drugs for Kidney Stones p. 93
Renal colic is a common problem in emergency departments. Stones <5 mm in diameter often pass spontaneously; stones >10 mm in diameter generally do not. The usual treatment for stones that do... - Aliskiren/Amlodipine (Tekamlo): Another Combination Tablet for Hypertension p. 94
The FDA has approved Tekamlo (Novartis), an oral fixed-dose combination of the direct renin inhibitor aliskiren (Tekturna) and the calcium channel blocker amlodipine (Norvasc,... - Miconazole (Oravig) for Oropharyngeal Candidiasis p. 95
The FDA has approved a buccal tablet formulation of miconazole (Oravig – Strativa) for local treatment of oropharyngeal candidiasis in adults. Miconazole has been available for many years...
December 13, 2010 (Issue 1353)
- Bromocriptine (Cycloset) for Type 2 Diabetes p. 97
The FDA has approved a new tablet formulation of bromocriptine mesylate (Cycloset – VeroScience) for treatment of type 2 diabetes in adults. Bromocriptine (Parlodel, and others) is... - Oral Fingolimod (Gilenya) for Multiple Sclerosis p. 98
The FDA has approved the marketing of fingolimod (Gilenya – Novartis) to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with... - Drugs for Female Sexual Dysfunction p. 100
Sexual complaints related to desire, arousal, orgasm and painful intercourse are common in women. Since the last Medical Letter article on this subject, some new information has become available. - Clindamycin-Tretinoin (Veltin Gel) for Acne p. 102
Veltin Gel (Stiefel), a fixed-dose combination of the antibiotic clindamycin phosphate 1.2% and the retinoid tretinoin 0.025%, has been approved by the FDA for topical treatment of acne... - In Brief: An Oral Contraceptive with Folate p. 104
Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz...
