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The Medical Letter on Drugs and Therapeutics • July 21, 2014 (Issue 1447)
The same pharmaceutical company (Iroko) that recently marketed low-dose diclofenac (Zorvolex) for treatment of mild to moderate acute pain1 has now received approval from the FDA to market a low-dose oral formulation of indomethacin (Tivorbex) for the same indication. Tivorbex is available in 20- and 40-mg capsules; conventional...
The Medical Letter on Drugs and Therapeutics • June 9, 2014 (Issue 1444)
A recent Medical Letter article reported renewed interest in the intranasal administration (off-label) of the opioid antagonist naloxone because of an increase in deaths from opioid overdose in the US.1 Now the FDA has approved a more practical alternative for emergency treatment of life-threatening opioid overdose in adults and children: a single-dose...
The Medical Letter on Drugs and Therapeutics • June 9, 2014 (Issue 1444)
The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended starting dose to 1 mg for both men and women because a new study found that an evening dose of 3 mg can impair driving skills, memory, and coordination for more than 11 hours....
The Medical Letter on Drugs and Therapeutics • May 26, 2014 (Issue 1443)
The FDA has approved the use of an equine heptavalent botulism antitoxin (BAT, Cangene Corporation). The new antitoxin includes antibodies against all 7 botulinum neurotoxin types (A-G). A human-derived antitoxin (BabyBIG) has been available for years for infant botulism. The heptavalent product is now the preferred antitoxin for adult botulism. It is a solution of immunoglobulin fragments...
The Medical Letter on Drugs and Therapeutics • April 28, 2014 (Issue 1441)
One of our readers has suggested that more attention should have been paid to a study comparing the antiplatelet effects of immediate-release and enteric-coated aspirin that appeared in Circulation last year.1 The safety benefits of enteric-coated aspirin are unclear. It may protect against dyspepsia, but not against major gastrointestinal bleeding...
The Medical Letter on Drugs and Therapeutics • March 31, 2014 (Issue 1439)
The FDA has approved a new injectable formulation of methotrexate (Otrexup – Antares) for use in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and for severe psoriasis in adults. On its web site (www.otrexup.com), the manufacturer states: "Otrexup is the first subcutaneous (SC) methotrexate (MTX...
The Medical Letter on Drugs and Therapeutics • March 3, 2014 (Issue 1437)
Prompted by the recent publication of 2 retrospective studies, the FDA has announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.1

The first study examined the records of 8709 men with low testosterone levels (<300 ng/dL) who underwent coronary angiography between 2005...
The Medical Letter on Drugs and Therapeutics • February 3, 2014 (Issue 1435)
The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the...
The Medical Letter on Drugs and Therapeutics • January 20, 2014 (Issue 1434)
The October 2013 suspension of marketing and sales of ponatinib (Iclusig – Ariad) for treatment of leukemia1 has been lifted by the FDA, and the drug is expected to return to the market this month with narrower indications and heightened safety warnings.2 The reason for its suspension was a high incidence of thrombotic events, some of them...
The Medical Letter on Drugs and Therapeutics • January 6, 2014 (Issue 1433)
The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA...
The Medical Letter on Drugs and Therapeutics • December 9, 2013 (Issue 1431)
An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European...
The Medical Letter on Drugs and Therapeutics • November 25, 2013 (Issue 1430)
The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels.1 Ponatinib is a tyrosine kinase inhibitor that was granted accelerated approval by the FDA in December 2012...
The Medical Letter on Drugs and Therapeutics • November 25, 2013 (Issue 1430)
The FDA recently announced changes in the labeling of ezogabine (Potiga – GSK/Valeant) to warn about the risks of retinal abnormalities, possible vision loss, and bluish skin discoloration, all of which could be permanent.1

Ezogabine was approved in 2011 for adjunctive treatment of partial-onset seizures in adults.2 The FDA first...
The Medical Letter on Drugs and Therapeutics • November 11, 2013 (Issue 1429)
The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database....
The Medical Letter on Drugs and Therapeutics • November 11, 2013 (Issue 1429)
Rates of meningococcal disease are highest in infancy, but until recently no meningococcal vaccine was approved for use in this age group. MenHibrix (GSK), a new conjugate vaccine that protects against Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib), has been approved by the FDA for use in infants ≥6 weeks old and Menveo, a...
The Medical Letter on Drugs and Therapeutics • October 28, 2013 (Issue 1428)
The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug was previously available in the US only from the manufacturer through an FDA Investigational New Drug (IND) application.

Meningoencephalitis caused by the free-living amebae...
The Medical Letter on Drugs and Therapeutics • October 14, 2013 (Issue 1427)
A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance treatment of opioid dependence. Zubsolv tablets have relatively greater bioavailability than previously approved sublingual film (Suboxone) and sublingual tablet formulations of...
The Medical Letter on Drugs and Therapeutics • September 16, 2013 (Issue 1425)
The transdermal patch formulation of the anticholinergic drug oxybutynin (Oxytrol – Watson) is now available over the counter (OTC) as Oxytrol for Women (MSD) for use in women with overactive bladder (OAB). It is the first treatment for OAB to become available OTC. Oxybutynin remains available only by prescription for men.

OAB, characterized by symptoms of urgency,...
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...