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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ondansetron (Zofran, and generics) used for prevention of cancer chemotherapy-associated nausea and vomiting has been withdrawn from the market because it can prolong the QT interval and could possibly cause a torsades de pointes cardiac arrhythmia.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...
The Medical Letter on Drugs and Therapeutics • June 11, 2012 (Issue 1392)
Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase the risk of cardiovascular death, especially in patients with a high baseline risk of cardiovascular disease.1 One possible mechanism is prolongation of the QT interval, which is known to occur rarely...
The Medical Letter on Drugs and Therapeutics • April 30, 2012 (Issue 1389)
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 higher risk of thromboembolism than CHCs containing other progestins.1

The new warning was based partly on an unpublished, FDA-funded, retrospective study that found a 1.7-...
The Medical Letter on Drugs and Therapeutics • April 16, 2012 (Issue 1388)
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia chrysanthemi, for use in combination with other chemotherapeutic agents for treatment of acute lymphoblastic leukemia (ALL) in patients who have had allergic reactions to Escherichia coli-derived asparaginase (...
The Medical Letter on Drugs and Therapeutics • March 5, 2012 (Issue 1385)
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 tamper-resistant technology designed to deter oxycodone abuse by injection or nasal snorting. Dissolving the crushed tablet in water or alcohol converts it into a viscous gel mixture, making it...
The Medical Letter on Drugs and Therapeutics • February 20, 2012 (Issue 1384)
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, diabetes or chronic renal disease, and for all those >50 years old. Salt reduction lowers blood pressure, and lowering blood pressure reduces the risk of myocardial infarction, stroke and death....
The Medical Letter on Drugs and Therapeutics • February 20, 2012 (Issue 1384)
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 indications including depression, mood enhancement, emotional well being, and promotion of normal sleep.

5-HTP is the intermediate metabolite in the biosynthesis of serotonin from L-...
The Medical Letter on Drugs and Therapeutics • February 6, 2012 (Issue 1383)
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 is bioequivalent to Implanon. Both products are single-rod subdermal contraceptives implanted into the inside of the upper arm; both provide reversible effective contraception for up to 3...
The Medical Letter on Drugs and Therapeutics • January 23, 2012 (Issue 1382)
A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal...