Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in statin-intolerant patients have become available.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

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.

Sildenafil citrate (Viagra - Pfizer) is the first oral drug approved by the FDA for treatment of erectile dysfunction. Alprostadil is also marketed for this indication but must be injected into the corpus cavemosum (Caverject) or pushed into the urethra (MUSE).

Since the last Medical Letter article on glucosamine for osteoarthritis (vol.39, page 91, September 26, 1997), more data have become available. Glucosamine is available in US pharmacies and health food stores as sulfate, hydrochloride or n-acetyl salt.

Most angioplasty procedures for coronary artery disease now include placement of stents, which have improved both short- and long-term success rates. The main limitation is restenosis, which occurs in about 25% of patients. Drug-eluting stents intended to reduce the incidence of restenosis have been approved for use in Europe, but not yet in the US.

The fixed-dose combination of olanzapine and fluoxetine (Symbyax - Lilly) has been approved by the FDA for treatment of depressive episodes associated with bipolar disorder. Olanzapine alone (Zyprexa), which is mainly used as an antipsychotic (Medical Letter 2003; 45:102), is FDA-approved for treatment of acute manic episodes and for maintenance treatment of bipolar disorder. Fluoxetine alone (Prozac, and others), which is mainly used as an antidepressant (Medical Letter 2003; 45:93), has no specific approval for use in bipolar...

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

The use of intracoronary stents in angioplasty procedures has improved both short- and long-term success rates. In recent years, drug-eluting stents (DESs) have largely replaced bare-metal stents (BMSs).

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.