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The Medical Letter on Drugs and Therapeutics • August 19, 2013 (Issue 1423)
The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after subarachnoid hemorrhage from a ruptured intracranial aneurysm. An older formulation of nimodipine has been available for such use for many years.1

Since 1988, nimodipine has...
The Medical Letter on Drugs and Therapeutics • June 24, 2013 (Issue 1419)
The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg tablet taken once (Plan B One-Step, and generics). A third emergency contraceptive, ulipristal (Ella – Watson), is available with a prescription.1 It appears that...
The Medical Letter on Drugs and Therapeutics • June 10, 2013 (Issue 1418)
The FDA is advising health care professionals not to prescribe valproate sodium (Depacon), valproic acid (Depakene, Stavzor, and generics) or divalproex sodium (Depakote, Depakote ER, and generics) for migraine prevention in pregnant women because a recently published study showed that IQ scores are decreased in children of mothers who took these drugs during pregnancy...
The Medical Letter on Drugs and Therapeutics • April 15, 2013 (Issue 1414)
Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an increased risk of cancer. Salmon calcitonin is available as 2 nasal sprays (Miacalcin, Fortical) and an injectable formulation (Miacalcin Injection) for use in osteoporosis....
The Medical Letter on Drugs and Therapeutics • April 1, 2013 (Issue 1413)
The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings are based on a retrospective study in The New England Journal of Medicine (reviewed previously in The Medical Letter2...
The Medical Letter on Drugs and Therapeutics • February 18, 2013 (Issue 1410)
A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width of a credit card and as thick as a smartphone. It has a retractable needle system and a red safety guard located at the same end as the needle. Activation of the device by removing the outer case...
The Medical Letter on Drugs and Therapeutics • February 4, 2013 (Issue 1409)
Two new trivalent influenza vaccines, Flucelvax (Novartis) and Flublok (Protein Sciences), will soon be available for prevention of seasonal influenza in adults ≥18 years old (Flucelvax) and 18-49 years old (Flublok). Unlike other available influenza vaccines, neither vaccine is produced in eggs, removing any concern regarding use in egg-allergic patients....
The Medical Letter on Drugs and Therapeutics • January 21, 2013 (Issue 1408)
The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product (Absorica – Cipher/Ranbaxy) for treatment of severe, recalcitrant nodular acne.

Isotretinoin can completely clear severe nodulocystic lesions, in some cases leading to...
The Medical Letter on Drugs and Therapeutics • January 7, 2013 (Issue 1407)
Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.
The Medical Letter on Drugs and Therapeutics • December 24, 2012 (Issue 1406)
The FDA has announced that the single 32-mg IV dose of ondansetron (Zofran, and generics) used for prevention of cancer chemotherapy-associated nausea and vomiting has been withdrawn from the market because it can prolong the QT interval and could possibly cause a torsades de pointes cardiac arrhythmia. For this indication, the only recommended dose of IV ondansetron is 0.15 mg/kg (...
The Medical Letter on Drugs and Therapeutics • October 29, 2012 (Issue 1402)
The FDA has asked Impax Laboratories/Teva Pharmaceuticals to stop production and distribution of Budeprion XL 300 mg, a generic extended-release formulation of the antidepressant bupropion (Wellbutrin XL), because it has found that Budeprion XL 300 mg releases bupropion more rapidly than Wellbutrin XL 300 mg, the original brand name product. Patients switched...
The Medical Letter on Drugs and Therapeutics • October 15, 2012 (Issue 1401)
A new effervescent formulation of alendronate (Binosto – Mission) was recently approved by the FDA for treatment of osteoporosis. The new 70-mg effervescent tablet is considered bioequivalent to the usual 70-mg tablet formulations of alendronate (Fosamax, and generics), which are difficult to swallow and can cause esophageal injury.1 No published studies of...
The Medical Letter on Drugs and Therapeutics • October 15, 2012 (Issue 1401)
The FDA has approved 2 intranasal HFA (hydrofluoroalkane) aerosols of the corticosteroids beclomethasone dipropionate (Qnasl – Teva Respiratory) and ciclesonide (Zetonna – Sunovion) for once-daily treatment of seasonal and perennial allergic rhinitis. They are the first HFA nasal steroids to become available in the US (HFA propellants do not deplete the ozone layer). Both drugs...
The Medical Letter on Drugs and Therapeutics • September 3, 2012 (Issue 1398)
In 2013 the FDA approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Lorcaserin (lor-ca-SER-in; Belviq – Arena/Esai) is a selective serotonin 2C receptor agonist. Qsymia (Vivus) is a fixed-dose combination of the weight-loss drug phentermine and an extended-release (ER) formulation of topiramate. The new...
The Medical Letter on Drugs and Therapeutics • August 20, 2012 (Issue 1397)
A patch formulation of the non-ergot dopamine agonist rotigotine (Neupro – UCB) has returned to the US market after a 4-year absence. Originally approved by the FDA in 2007 for treatment of early Parkinson’s disease,1 it was withdrawn in 2008 because of crystallization of the drug in the patch, which could have led to under-dosing. The new patch has somewhat broader...
The Medical Letter on Drugs and Therapeutics • August 6, 2012 (Issue 1396)
Breaking drug tablets in half is a common practice. Since our last article on this subject, some new data have become available.
The Medical Letter on Drugs and Therapeutics • August 6, 2012 (Issue 1396)
Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been approved by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. It is the first drug to be approved for this indication. The...
The Medical Letter on Drugs and Therapeutics • July 23, 2012 (Issue 1395)
The most recent guidelines from the Infectious Diseases Society of America (IDSA) and its European counterpart on the choice of antimicrobials for treatment of uncomplicated urinary tract infections (UTIs) in non-pregnant women focus on the unnecessary use of fluoroquinolones to treat uropathogens that are increasingly becoming resistant to them. Resistance of Escherichia coli to...
The Medical Letter on Drugs and Therapeutics • July 9, 2012 (Issue 1394)
The FDA has approved taliglucerase alfa (ta lee gloo´ se rays; Elelyso – Pfizer/Protalix), a recombinant form of glucocerebrosidase, for treatment of adults with Type 1 Gaucher disease. These patients have a genetic deficiency of the lysosomal enzyme glucocerebrosidase that leads to accumulation of glucosylceramide in the lysosomes of reticuloendothelial cells, primarily in the liver,...
The Medical Letter on Drugs and Therapeutics • June 25, 2012 (Issue 1393)
The US Preventive Services Task Force (USPSTF) has issued a Draft Recommendation Statement saying, in effect, that community-dwelling women and men should not take calcium and vitamin D supplements for primary prevention of osteoporotic fractures because the evidence that they are helpful is insufficient and they increase the risk of kidney stones. The Medical Letter has said previously that...