The FDA has approved the opioid agonist hydromorphone in a once-daily extended-release (ER) oral tablet formulation (Exalgo – Covidien) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, long-term therapy. Another hydromorphone ER formulation (Palladone – Purdue) was available previously, but was withdrawn from the market because taking it with alcohol could interfere with the extended-release mechanism and lead to rapid release of potentially lethal amounts of the drug ("dose-dumping").

The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Osimertinib is the first targeted therapy to be approved in the US for this indication. The drug was previously approved for first-line treatment of adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and for treatment of EGFR T790M mutation-positive NSCLC in adults whose disease progressed...

The FDA has approved tesamorelin (Egrifta – EMD Serono), an injectable synthetic analog of growth-hormone- releasing factor (GRF), for reduction of excess abdominal fat in patients with lipodystrophy associated with HIV infection. Growth hormone (somatropin – Serostim; EMD Serono) has been available for years for treatment of HIV wasting.

The FDA has approved ibrutinib (eye broo' ti nib; Imbruvica – Janssen/Pharmacyclics), an oral kinase inhibitor, for second-line treatment of chronic lymphocytic leukemia (CLL). It is the first kinase inhibitor to be approved for CLL. Ibrutinib was approved earlier for second-line treatment of mantle cell lymphoma, a rare form of B-cell non-Hodgkins lymphoma.

On page 100 of the article "Major Changes in Endocarditis Prophylaxis for Dental, GI and GU Procedures", under the section Highest-Risk Procedures, the word "rubber" should have been omitted. Placement of orthodontic rubber bands is not a highest-risk procedure that justifies prophylaxis; placement of orthodontic (metal) bands is. An orthodontic band is a metal ring that surrounds the tooth and is pressed into place causing movement in closely-spaced teeth and sometimes bleeding when the bands are placed close to the gumline.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

Recent reports (D Kaye.Clin Infect Dis April 1, 2008;46:iii) indicate that 2 of the 3 components of this year's influenza vaccine (Med Lett Drugs Ther 2007;49:81), the influenza B and A/H3N2 antigens, do not matchup well with circulating strains. The B component is probably not protective. The A/H3N2 antigen in the vaccine probably provides some protection, particularly for high-risk patients. The third component, the A/H1N1 antigen, is protective against circulating A/H1N1 influenza viruses, but these viruses, unlike previous A/H1N1 strains, are developing some resistance to oseltamivir...

The CDC recently reported that fluoroquinoloneresistant strains of Neisseria meningitidis have been detected for the first time in the US in an area around the border of North Dakota and Minnesota (CDC. MMWR, Feb 22, 2008). These isolates were all serogroup B, for which meningococcal vaccines (Med Lett Drugs Ther 2005; 47:29) do not offer protection. Since many laboratories do not test N. meningitidis for antimicrobial susceptibility, it is possible that such resistance is more widespread. A single oral dose of ciprofloxacin (Cipro, and others) 500 mg has been used for prophylaxis after close...

(Med Lett Drugs Ther 2008; 50:91) In the Clinical Studies section, the complete response rate with chlorambucil for CLL was 2% (not 24%).

The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Glucarpidase has been available in the US since 2007 under a compassionate use open-label treatment protocol (Clinical Trials and Consulting Services, 1-877-398-9829), which will remain in effect until the drug becomes commercially available later this year. There is currently a shortage of IV methotrexate in the US.