Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.

Acute toxic reactions to drugs of abuse continue to be important problems. Some patients may have mixed intoxications with complex combinations of signs and symptoms.

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 years.1 Nexplanon has a redesigned preloaded applicator intended to make insertion easier and reduce the risk of improperly placed devices. Proper placement is necessary to ensure adequate contraceptive efficacy and to facilitate future...

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 (Elspar or pegaspargase [Oncaspar]).ALL is the most common malignancy of childhood. Multidrug chemotherapy can cure about 80% of children with ALL.1 Initial treatment ("induction") usually includes vincristine, a glucocorticoid, and an...

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 initiates an audio voice recording that provides step-by-step instructions and a 5-second countdown during the injection. The shelf-life of the epinephrine in the auto-injector is 18 months; the shelf-life of the battery is...

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.1Ezogabine was approved in 2011 for adjunctive treatment of partial-onset seizures in adults.2 The FDA first warned about these risks in April 2013.3 At that time, skin discoloration had developed in 38 of an estimated 605 patients (6.3%) who had taken the drug (most for ≥2 years) in various studies. Retinal pigment abnormalities were found in 11 of 36 patients who had...

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) for self-administration delivered once weekly by auto-injector." Methotrexate has been available as a once-weekly injection (IM or SC) for these indications for many years,1 but not specifically for self-administration and not in a single-dose auto-injector. Methotrexate is...

Combining a statin with another drug that lowers low-density lipoprotein cholesterol (LDL-C), such as colesevelam (Welchol), niacin (Niaspan, and others), or ezetimibe (Zetia), can reduce LDL-C levels more than a statin alone, but studies convincingly demonstrating that such combinations improve clinical outcomes have been lacking. The results of a long-term randomized, double-blind clinical trial (IMPROVE-IT) recently presented at the American Heart Association's Scientific Sessions 2014 indicate that addition of ezetimibe to simvastatin in high-risk patients reduces cardiovascular...

Many patients ask their physicians whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamin supplements.

Advertisements for atorvastatin (Lipitor), the market leader facing generic competition, have been in the news recently in the US. Lovastatin, pravastatin and simvastatin are all available generically at a much lower retail price or lower co-pay than atorvastatin.