Benzyl alcohol combats head lice
A new prescription medication for the treatment of head-lice infestation has been approved by the FDA for patients age 6 months and older. Benzyl alcohol lotion 5%, distributed by Sciele Pharma, Inc., is the first head lice product approved by the FDA with benzyl alcohol as the active ingredient.
The safety and effectiveness of benzyl alcohol lotion was shown in two studies of 628 people, ages 6 months and older, with head-lice infestation. They received two, 10-minute treatments of either benzyl alcohol lotion or a topical placebo, 1 week apart. Fourteen days after the final treatment, more than 75% of the subjects treated with the benzyl alcohol lotion were lice-free.
Adverse reactions associated with the medication include irritation of the skin, scalp, and eyes, and numbness at the application site.
The product should be applied only to the scalp or the hair attached to the scalp. It is not approved for children younger than 6 months of age. Use in premature infants could lead to serious adverse events, including death.
Once-daily Prevacid now sold OTC
Novartis has received FDA approval for nonprescription Prevacid 24HR (lansoprazole delayed-release capsules 15 mg). Prevacid 24HR is the first over-the-counter (OTC) proton pump inhibitor approved for the treatment of frequent heartburn since 2003, and is expected to be available this year. It was approved in its original prescription strength and is the only proton pump inhibitor containing the active ingredient lansoprazole to be approved for OTC treatment of frequent heartburn.
Prevacid 24HR is approved as a 14-day course of treatment and should be taken once daily before eating in the morning. Novartis licensed the Prevacid trademark from Takeda Pharmaceuticals.
New hypertension treatment approved
The fixed-dose, combination treatment AZOR (amlodipine and olmesartan medoxomil) is now approved for first-line, hypertension treatment in patients likely to need multiple agents to achieve BP goals. AZOR is a product of Daiichi Sankyo, Inc. The calcium channel blocker/angiotensin II receptor blocker was originally approved in 2007 for the treatment of hypertension alone or in combination with other antihypertensive agents.
The approval of AZOR for first-line use is in line with the current U.S. guidelines to prescribe combination medications as initial therapy for patients likely to need more than one drug to successfully lower BP.
Initial therapy with AZOR is not recommended in patients age 75 or older, or in patients with hepatic impairment. AZOR is contraindicated in pregnant women and should be discontinued as soon as possible after pregnancy is detected.
Stronger labels required on botulinum toxin
Prompted by reports of serious adverse events, the FDA notified healthcare professionals that the product labeling of licensed botulinum toxin products will be strengthened. In addition, a boxed warning will be added to these products regarding the risk of adverse events when the effects of the toxin spread beyond the injection site. The changes are part of an ongoing safety review that began in February 2008.
The adverse reactions, which cause symptoms similar to those of botulism, have mostly been reported in children with cerebral palsy who were treated with the products for muscle spasticity, an unapproved use. Symptoms have also been reported in adults treated for both approved and unapproved uses.
The agency will also require that manufacturers of these products develop and implement a Risk Evaluation and Mitigation Strategy (REMS), including a communication plan to provide more information about the risk for distant spread of botulinum toxin effects after local injection. Additionally, information explaining that botulinum toxin products cannot be interchanged will be included in the REMS as well as a medication guide explaining the risks to patients and caregivers.