The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine...

Omega-3 (n-3) polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential human nutrients. The main dietary source of PUFAs is fatty fish such as salmon, but small amounts may be converted from α-linolenic acid in nuts, seeds, and plant oils such as canola or flaxseed oil. An increased intake of these fatty acids has been shown to modify membrane function, inhibit thrombus formation, decrease inflammation, lower plasma triglycerides, and alter the electrical activity of the myocardium.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Cholinesterase inhibitors are now used routinely in patients with dementia. Rivastigmine transdermal system (Exelon Patch - Novartis), a patch formulation of the cholinesterase inhibitor rivastigmine tartrate, has been approved by the FDA for treatment of mild to moderate dementia associated with Alzheimer's or Parkinson's disease. An oral formulation of rivastigmine tartrate has been available in the US since 2000,2 but gastrointestinal adverse effects possibly related to rapidly rising serum concentrations have limited its use.

The FDA has approved the marketing of desvenlafaxine (Pristiq - Wyeth), the main active metabolite of venlafaxine (Effexor, and others - Wyeth), for treatment of major depressive disorder. Venlafaxine, a norepinephrine and serotonin reuptake inhibitor (SNRI), is available generically as an immediate-release tablet. Venlafaxine extended-release capsules (Effexor XR) are scheduled to go off-patent in 2010.

Clevidipine (Cleviprex - The Medicines Company), a dihydropyridine calcium channel blocker (CCB), has been approved by the FDA for intravenous (IV) use in lowering high blood pressure. It is the second IV CCB to be marketed in the US; nicardipine has been available in an IV formulation (Cardene IV) for more than 10 years. Like IV nicardipine, clevidipine will probably be used mainly for urgent treatment of hypertension in intensive care units, operating rooms and emergency departments.

An old conjugated estrogens vaginal cream (Premarin Vaginal Cream - Wyeth) has been newly approved by the FDA specifically for treatment of moderate to severe dyspareunia due to vulvar and vaginal atrophy associated with menopause. Synthetic conjugated estrogens A vaginal cream (Barr) has also been approved for this indication, but has not yet been marketed.

Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

The FDA has approved ixekizumab (Taltz – Lilly), an injectable humanized interleukin (IL)-17A antagonist, for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is the second IL-17A antagonist to be approved for this indication in the US; secukinumab (Cosentyx – Novartis) was the first.