In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

Concerns have surfaced again at the FDA and in the media about the safety of acetaminophen and the multiplicity of products on the market in the US that contain various amounts of it.

Acrivastine/Pseudoephedrine (Semprex-D) for Seasonal Allergic Rhinitis (Burroughs-Wellcome), a combination of acrivastine with pseudoephedrine hydrochloride, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. Acrivastine is a new H 1 -receptor antagonist with a chemical structure similar to that of triprolidine (Actidil, and others) (RN Brogden and D McTavish, Drugs, 41:927, 1991). Pseudoephedrine is an α -adrenergic agonist. The combination is available only by prescription.

The number of cough remedies available in the USA continues to multiply, but most products contain the same or similar ingredients in varying combinations. Most acute coughs do not require treatment with drugs, especially in children, and suppression of a productive cough may be harmful.

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.

Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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Rasagiline (Azilect - Teva), a monoamine oxidase-type B (MAO-B) inhibitor, was recently approved by the FDA for once-daily oral treatment of Parkinson's disease (PD). It can be taken alone for treatment of early disease or with levodopa/carbidopa (Sinemet, and others) for advanced disease. Selegiline (Eldepryl, and others), the first MAO-B inhibitor marketed in the US, has been available since 1988; a new lower-dose disintegrating tablet (Zelapar) was recently approved.

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).