The FDA has added a "black box" warning about the risks of QT prolongation and the potentially fatal torsades de pointes (TdP) ventricular tachycardia to the labeling of droperidol (Inapsine - Akorn), an antiemetic used mostly in anesthesia. The Canadian Health Protection Branch has issued a similar warning. Some anesthesiologists have written to The Medical Letter to express their displeasure with these warnings.

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control...

Apremilast (Otezla – Celgene), an oral phosphodiesterase type-4 (PDE4) inhibitor, has been approved by the FDA for treatment of active psoriatic arthritis in adults. It is the fi rst PDE4 inhibitor to be approved for this indication.

Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the FDA initially only as adjunctive treatment for partial seizures. Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the S-isomer of the active metabolite of oxcarbazepine. Oxcarbazepine itself is similar to carbamazepine. Both oxcarbazepine and carbamazepine are available generically.

Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

Spironolactone, an aldosterone receptor antagonist, has been FDA-approved for many years for treatment of edema, hypertension and primary hyperaldosteronism. Recently, it was reported to improve morbidity and mortality in patients with severe heart failure.

Ciclopirox nail lacquer (Penlac - Dermik) has been approved by the FDA for treatment of mild-to-moderate onychomycosis due to Trichophyton rubrum, without involvement of the lunula. The drug has been available for many years as a lotion and cream (Loprox) for treatment of cutaneous fungal infection

The American Heart Association (AHA) recently published a statement saying that it would be reasonable to obtain an electrocardiogram (ECG) in children being evaluated for stimulant drug therapy for attention deficit hyperactivity disorder (ADHD). A subsequent news release in conjunction with the American Academy of Pediatrics provided a clarification, saying that it would be reasonable to consider obtaining an ECG in such children.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.

Most patients with end-stage renal disease develop hyperphosphatemia, which can lead to secondary hyperparathyroidism, vascular calcification, and cardiovascular mortality. The FDA has approved sucroferric oxyhydroxide (Velphoro – Fresenius Medical Care), a chewable phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the first iron-based phosphate binder to be approved for this indication.