The FDA has approved the monoamine oxidase type B (MAO-B) inhibitor safinamide (Xadago – US Worldmeds) as an adjunct to levodopa/carbidopa for management of "off" episodes in patients with Parkinson’s disease (PD). It is the first reversible MAO-B inhibitor to be approved for this indication. Selegiline (Eldepryl, and others) and rasagiline (Azilect, and generics), two irreversible MAO-B inhibitors, have been used alone and as adjuncts to levodopa/carbidopa for many years. Safinamide is not approved for use as monotherapy.

The FDA has approved an extended-release oral suspension formulation of amphetamine (Adzenys ER – Neos) for treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥6 years old. The same extended-release amphetamine product is available as an orally disintegrating tablet and is marketed as Adzenys XR-ODT. Another extended-release oral suspension formulation of amphetamine, Dyanavel XR, was approved earlier.

View the Comparison Table: Drugs for Parkinson's Disease

A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009.

The FDA has approved ziconotide (Prialt - Elan) intrathecal infusion for management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Ziconotide is a synthetic neuronal N-type calcium channel blocker. It is intended for use with a programmable implanted microinfusion device, but an external microinfusion device can be used temporarily.

The US Food and Drug Administration has ordered removal of phenylpropanolamine from over-the-counter cold remedies and weight loss aids. The FDA based its decision on a recent study showing an increased risk of hemorrhagic stroke in young women taking the drug.

Isotretinoin (Accutane - Roche), an effective oral drug for treatment of acne, will soon be available generically. Concerns about its adverse effects, particularly psychiatric symptoms in adolescents, have been widely reported in the media.

Liquid diets for weight reduction, once discredited because of their adverse effects, are becoming popular again. Now, formula diets are available through physicians or hospitals as part of a packaged weight-reduction program that includes nutrition education and modification of eating and exercise habits. Three widely used programs are Optifast (Sandoz), Medifast (Nutrition Institute of Maryland, 1840 York Road, Timonium, MD 21093) and HMR (Health Management Resources, 59 Temple Place, Boston, MA 02111).

At a US Senate hearing prompted by the withdrawal of Vioxx, an FDA officer cited 5 drugs as potentially dangerous. It may be useful to revisit Medical Letter reviews of these drugs.

Alzheimer's disease (AD) is the most common cause of dementia, but cognitive decline also occurs in other neurological conditions, such as Parkinson's disease, Lewy body dementia, vascular dementia, and frontotemporal dementia.