Drug for Seborrheic Dermatitis Approved
The FDA has approved Extina (Stiefel Laboratories, Inc.) a new ketoconazole 2% foam for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. The medication is used twice daily, in the morning and evening, for 4 weeks.
The new medication uses thermolabile hydroethanolic-foam technology to provide quick absorption into the skin. The foam can be used on skin with or without hair. It is nondrying and leaves no residue.
The most common side effects were application site burning and application site reactions.
Patients should be instructed to hold the container upright and dispense the foam into the cap of the can or another cool surface. Directly dispensing the foam into the hand is not recommended because the foam begins to melt immediately on contact with warm skin. Instruct the patient to apply the foam in small amounts with the fingertips and gently massage into the affected areas until absorbed. Hair should be moved to allow direct application to the skin. Extina foam is flammable. Advise the patient to keep the foam and container away from an open flame or direct heat.
Restricted Use of Zelnorm Permitted for Some
The FDA is permitting the restricted use of tegaserod maleate (Zelnorm) for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women under 55 years of age who meet certain guidelines. Marketing and sales of tegaserod maleate were suspended in March 2007 because a safety analysis found an increased risk of heart attack, stroke, and unstable angina in patients treated with the drug compared with placebo.
The program allows use of the drug for those with IBS-C and CIC whose healthcare providers decide the drug is medically necessary. Patients must sign consent forms to ensure they understand potential risks and benefits of treatment with tegaserod maleate.
Patients who will be allowed to use tegaserod maleate under the new FDA program must meet strict criteria and have no known or preexisting heart problems and be in critical need of the drug. The drug remains off the market for general use.
Recall of Invanz Lots
Merck & Co., Inc. is voluntarily recalling three lots of ertapenem (Invanz) 1 gram as a precautionary measure due to the possibility that glass pieces could be present in some vials within these lots.
The lots that are being recalled are numbers: 0803930, 0803940, and 0803950. No other lots are affected by this recall. All lots have an expiration date of October 2008.
While Merck believes the incidence of Invanz vials that could contain glass particles is extremely low, in the event that a dose of Invanz was administered and did contain glass particles, the risk of associated medical harm is unlikely.
Medical questions can be directed to Merck's National Service Center at 1-800-672-6372.
New Transdermal Patch for Alzheimer's
Novartis has received FDA approval for the Exelon Patch, a rivastigmine transdermal delivery system for the treatment of mild-to-moderate Alzheimer's disease. The patch is also approved for treating patients with mild-to-moderate Parkinson's disease dementia.
The patch is applied to the back, chest, or upper arm and is available in 4.6 mg and 9.5 mg strengths.
According to Novartis, the Exelon Patch maintains steady drug levels in the bloodstream and improves tolerability.
The most common side effects included nausea and vomiting, loss of appetite, anxiety, difficulty sleeping, dizziness, headache, diarrhea, reactions at the application site, and fatigue.