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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 Originally approved by the FDA in 2007 for treatment of early Parkinson’s disease,1 it was withdrawn in 2008 because of crystallization of the drug in the patch, which could have led to under-dosing.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...
The Medical Letter on Drugs and Therapeutics • January 9, 2012 (Issue 1381)
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 are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.

The manufacturer’s application for this new indication was...
The Medical Letter on Drugs and Therapeutics • December 12, 2011 (Issue 1379)
The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C...
The Medical Letter on Drugs and Therapeutics • November 28, 2011 (Issue 1378)
The FDA has approved icatibant (Firazyr – Shire), a selective bradykinin B2 receptor antagonist, for treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare autosomal dominant disorder (estimated prevalence 1:10,000-50,000) in which patients experience recurrent and frequently unpredictable attacks of angioedema lasting 2-5 days, typically involving the extremities,...
The Medical Letter on Drugs and Therapeutics • November 14, 2011 (Issue 1377)
A recent editorial in The New England Journal of Medicine commented on the negative results of a clinical trial (published in the same issue) of nesiritide, a drug that had been approved by the FDA in 2001 (conditionally approved by Health Canada in 2007) for relief of dyspnea in patients with acutely decompensated heart failure. The authors of the recent clinical trial concluded: "On...
The Medical Letter on Drugs and Therapeutics • October 31, 2011 (Issue 1376)
The surprising observation that oral administration of the beta-blocker propranolol (Inderal, and others) can stop the growth and rapidly cause the involution of disfiguring or life-threatening infantile hemangiomas1 has quickly led to a series of confirmatory observations and now a controlled trial. The mechanism of this effect is not known, but is thought to be...