The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.

Preliminary results from a new study, unpublished but reported in a press release from the National Cancer Institute and widely disseminated in the public press, suggest that raloxifene (Evista) might be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women.

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, which is thought to be mainly a systemic effect of prostaglandin inhibition.ANTIPLATELET EFFECTS OF ASPIRIN — Aspirin irreversibly acetylates cyclooxygenase-1, blocking thromboxane synthesis and inhibiting platelet activation and aggregation for...

The FDA has approved rivaroxaban (Xarelto – Janssen), an oral direct factor Xa inhibitor, for prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery.

Taking aspirin to prevent recurrence or worsening of cardiovascular disease has become a common practice in recent years (Medical Letter, 28:31, 1986). Now, the US Food and Drug Administration is considering whether aspirin can also be advertised for prevention of a first myocardial infarction in previously healthy people.

The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for decades, and is available without a prescription in some countries. It has been available in the US since 1987 for use with coagulation factors in patients with hemophilia undergoing dental extractions.

Full-page newspaper advertisements and a series of television commercials have urged patients with atrial fibrillation to "rethink warfarin" in favor of Eliquis (apixaban – Bristol-Myers Squibb). Apixaban is the latest of 3 new oral anticoagulants now competing with warfarin (Coumadin, and others) for the oral anticoagulant market.

The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.

Antiplatelet drugs are the drugs of choice for prevention and treatment of arterial thrombosis. Anticoagulants are the drugs of choice for prevention and treatment of venous thromboembolism and for prevention of cardioembolic events in patients with atrial fibrillation.

The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of pulmonary thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment of rheumatoid arthritis (RA),2 psoriatic arthritis, and ulcerative colitis.In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive add-on treatment with tofacitinib 5 mg twice daily (the...