Two new platelet glycoprotein IIb/IIIa receptor antagonists have been approved for marketing by the US Food and Drug Administration (FDA). Eptifibatide (ep ti fi' ba tyde; Integrilin - Cor, Key) is approved for use in acute coronary syndromes (unstable angina or non-Q-wave myocardial infarction) or percutaneous coronary intervention (angioplasty or atherectomy). Tirofiban (tye roe fye' ban; Aggrastat - Merck) is approved for acute coronary syndromes, but not for angioplasty without an acute coronary syndrome. Abciximab (ReoPro), a monoclonal antibody glycoprotein IIb/IIIa receptor...

Rofecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis, acute pain and menstrual pain.

Zonisamide (Zonegran - Elan Pharma), a sulfonamide chemically unrelated to other antiepileptic drugs, has been approved by the FDA for adjunctive use in adults with partial seizures. Zonisamide has been available in Japan for more than 10 years.

Aripiprazole (Abilify - Bristol-Myers Squibb/Otsuka), a quinolinone derivative, has been approved by the FDA for treatment of schizophrenia.

Modafinil (Provigil - Cephalon; Alertec - Draxis in Canada), first approved by the FDA in 1999 for treatment of excessive daytime sleepiness associated with narcolepsy (Medical Letter 1999; 41:30), has now also been approved for treatment of patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome (OSAHS) or shift work sleep disorder (SWSD) (DSM-IV, text revision, Washington, DC: American Psychiatric Association, 2000, page 622).

Angiotensin receptor blockers (ARBs) are widely used as an alternative to angiotensin converting enzyme (ACE) inhibitors for treatment of hypertension because they lower blood pressure without inducing a cough. It has not been established that they provide the same cardiac benefits as ACE inhibitors. Recently, an editorial in the British Medical Journal suggested that ARBs may increase the risk of myocardial infarction.

Hyperphosphatemia in end-stage renal disease can lead to secondary hyperparathyroidism, renal osteodystrophy, metastatic calcification and cardiovascular mortality. addition to dietary restriction of phosphorus and hemodialysis, drugs that bind phosphates in the gut are usually needed as well. Aluminum hydroxide is no longer recommended for long-term use because of concerns about its toxicity.

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

The FDA has approved the use of the 5α-reductase inhibitor dutasteride (Avodart - GlaxoSmithKline) together with the alpha₁-blocker tamsulosin (Flomax - Boehringer Ingelheim) for treatment of benign prostatic hyperplasia (BPH). Use of an alpha1-blocker with a 5α-reductase inhibitor has been a common practice for years, but FDA approval of a particular combination permits the manufacturers to add an indication for it in both package inserts, recommend dosage for combination use, and advertise the benefits of using the 2 drugs together.

The FDA has approved the marketing of alvimopan (Entereg - Adolor/GlaxoSmithKline), a selective muopioid receptor antagonist, for oral treatment of postoperative ileus after bowel resection. The only other drug in this class available in the US is subcutaneously injected methylnaltrexone (Relistor), which is approved for treatment of opioid-induced constipation in patients with advanced illness receiving palliative care.