The FDA has requested the removal of the suicidal behavior and ideation warning from the labels of the 3 glucagon-like peptide-1 (GLP-1) receptor agonists approved for chronic weight management: liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The warning was initially included in the labels of these drugs based on an increased risk of suicidal behavior and ideation observed with older weight loss drugs.

The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C inhibits coagulation, increases fibrinolysis and has anti-inflammatory properties. FDA approval of Xigris (for patients with severe sepsis at high risk of death) was based on a single study (PROWESS).2 Post-marketing studies found a...

The FDA has authorized two manufacturers (Teva, Mylan) to market generic formulations of celecoxib (Celebrex – Pfizer), the only COX-2 selective inhibitor remaining on the US market. Celecoxib is less likely than nonselective NSAIDs to cause gastric ulcers or other GI toxicity,1 and unlike traditional NSAIDs, it does not have an antiplatelet effect.Celecoxib is much less COX-2 selective than rofecoxib (Vioxx), which was removed from the US market because of an increased risk of cardiovascular events. One analysis of randomized clinical trials that included a total of about 26,000 patients...

The FDA has required a new boxed warning in the label of the subcutaneously injected immunomodulatory drug glatiramer acetate (Copaxone, Glatopa, and generics) about a risk of anaphylaxis. Glatiramer has been used for years to treat relapsing forms of multiple sclerosis (MS).

The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

Sertraline (Zoloft - Roerig), a serotonin reuptake inhibitor, was recently approved for marketing by the US Food and Drug Administration for treatment of depression. Another serotonin reuptake inhibitor, fluoxetine (Prozac), is prescribed more frequently in the USA than any other antidepressant (Medical Letter, 32:83, 1990).

hydrochloride (Ticlid - Syntex), a platelet aggregation inhibitor that has been available in Europe for more than a decade, was recently approved by the U.S. Food and Drug Administration to decrease the risk of thrombotic stroke in men and women who have had premonitory signs of stroke or have had a completed thrombotic stroke. The manufacturer is promoting the drug for patients intolerant to aspirin or with conditions for which aspirin has not been approved (previous thrombotic stroke; transient ischemic attacks in women). The drug has also been used for prevention of myocardial ...

Loratadine (Claritin - Schering), a new H 1 -receptor antagonist, has been approved by the U.S. Food and Drug Administration for treatment of seasonal allergic rhinitis in patients more than 12 years old. It will compete with older, relatively sedating drugs such as chlorpheniramine (Chlor-Trimeton, and others) and clemastine (Tavist - Medical Letter, 35:9, 1993) and with newer relatively non-sedating agents such as terfenadine (Seldane) and astemizole (Hismanal).

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

Fexofenadine (fex oh fen' a deen) hydrochloride (Allegra - Hoechst Marion Roussel) has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. An active metabolite of terfenadine, fexofenadine is being heavily advertised as "nonsedating...without 'black box' warnings."