Use of a selective serotonin reuptake inhibitor (SSRI) is common in women taking tamoxifen (Nolvadex, and others) for breast cancer, both to treat depression and to decrease hot flashes. However, tamoxifen must be metabolized by CYP2D6 to become pharmacologically fully active (MJ Higgins et al. J Natl Compr Canc Netw 2009; 7:203), and the SSRIs fluoxetine (Prozac, and others) and paroxetine (Paxil, and others) are strong inhibitors of CYP2D6. Sertraline (Zoloft, and others) inhibits CYP2D6 to a lesser extent. Citalopram (Celexa, and others) and escitalopram (Lexapro), the 2 other SSRIs...

The FDA has required the manufacturer of Plavix, an antiplatelet drug used in addition to aspirin to prevent cardiovascular events in high-risk patients,1 to add a boxed warning to the package insert about the risk of a poor response to the drug in patients with genetic polymorphisms of the cytochrome P450 enzyme CYP2C19. Clopidogrel is a prodrug and CYP2C19 is mainly responsible for its bioactivation. The Medical Letter reported last year that several studies have found higher rates of cardiovascular events, including stent thrombosis, in patients with these polymorphisms taking...

The FDA has approved velaglucerase alfa (Vpriv – Shire), a new formulation of glucocerebrosidase prepared from human fibroblasts, for treatment of the nonneurologic form of Gaucher’s disease (Type 1). Patients with Gaucher’s disease have a congenital deficiency of glucocerebrosidase that leads to accumulation of glucosylceramide, the end-product of sphingolipid catabolism, in the lysozymes of reticuloendothelial cells in the liver, spleen and bone marrow.Velaglucerase is the second form of the enzyme now available in the US; imiglucerase (Cerezyme – Genzyme), which is produced by...

A Medical Letter subscriber was surprised to discover that a new Citracal product contained not only calcium citrate, but also calcium carbonate. Citracal Plus Bone Density Builder actually contains more calcium carbonate per tablet than calcium citrate (240 mg vs. 60 mg). Another Citracal product, Citracal Plus Heart Health, also contains more calcium carbonate than calcium citrate. Many clinicians prefer calcium citrate because it can be taken with or without food, while calcium carbonate must be taken with food for optimal absorption. Other familiar over-the-counter (OTC) names also contain...

The FDA has approved rilpivirine (Edurant – Janssen), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use with other antiretroviral agents for treatment of HIV-1 infection in treatment-naive adults. Rilpivirine is also available in a fixed-dose combination with emtricitabine and tenofovir (Complera – Gilead).

Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs for treatment of adults with multidrug-resistant pulmonary tuberculosis (MDR-TB). It is the first drug approved specifically to treat MDR-TB.

The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder. Levomilnacipran is the more active enantiomer of milnacipran (Savella), which was approved in 2009 for management of fibromyalgia. Fetzima has not been studied in fibromyalgia.

The nasal spray formulation of the corticosteroid fluticasone propionate is now available over the counter (OTC) as Flonase Allergy Relief (GSK) in the same strength as the prescription product (Flonase, and generics) for patients ≥4 years old with seasonal or perennial allergic rhinitis. It is the second corticosteroid nasal spray to become available OTC; triamcinolone acetonide (Nasacort Allergy 24HR) was the first. Unlike prescription Flonase, the OTC product is FDA-approved for reduction of ocular as well as nasal symptoms. Brand-name prescription Flonase has been...

The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.

The FDA has approved the hedgehog pathway inhibitor sonidegib (Odomzo – Novartis) for oral treatment of locally advanced basal cell carcinoma that cannot be treated with surgery or radiation or has recurred following such treatment. Vismodegib (Erivedge), another oral hedgehog pathway inhibitor, was approved earlier for the same indication and also for treatment of metastatic basal cell carcinoma.