ADHD Transdermal System for Children
The FDA approved the first transdermal methylphenidate system for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years of age. The product, methyl phenidate transdermal system (Daytrana), is manufactured by Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals.
The patch is a once-daily product that is applied early in the morning and removed 9 hours later. The patch is designed to remain in place during normal daily activities, but if on rare occasions it falls off, a replacement patch may be applied at a different site. The total daily wear time must not exceed 9 hours.
Methylphenidate transdermal system is available in four strengths: 10-, 15-, 20-, and 30 mg. The patch is to be worn on the hip, alternating left and right sides daily.
In clinical trials, the methyl pheni date transdermal system was generally well tolerated. Adverse events were generally mild to moderate, and included insomnia, anorexia, significant weight loss, nausea, vomiting, and affect lability.
The patch also carries the same contraindications against use in children who have heart problems as all ADHD drugs. Methylpheni date transdermal system also carries a warning about possible skin sensitivity.
In addition, the patch is contraindicated in pediatric patients with significant anxiety, tension, or agitation; glaucoma; tics; Tourette syndrome or family history of Tourette syndrome; and those receiving or having recently received monoamine oxidase inhibitor therapy.
Second Drug OK'd for Prevention of Influenza A and B
GlaxoSmithKline's zanamivir for inhalation (Relenza) is now approved for the prevention of influenza in adults and children 5 years of age and over. The antiviral was previously approved for the treatment of influenza A and B virus infections in adults and children.
Oseltamivir phosphate (Tamiflu) was approved for both prevention and treatment of the flu.
Studies of zanamivir showed it reduced the incidence of disease in both younger and older populations. The most common adverse events in adults and adolescents were headaches, diarrhea, nausea and vomiting, nasal irritation, bronchitis, and cough. In children, the most common side effects were ear, nose, and throat infections, vomiting, and diarrhea. Rashes and allergic reactions were reported less commonly.
Zanamivir does not replace an annual flu shot and is not recommended for treatment or prophylaxis of seasonal influenza in people with underlying airway disease such as asthma or chronic obstructive pulmonary disease.
Less Restrictive Monitoring for Parkinson's Drug
The FDA approved less restrictive hepatic monitoring guidelines for tolcapone (Tasmar), allowing less frequent liver function monitoring for patients taking the drug and allowing continuation of therapy until liver enzyme levels exceed twice the upper limit of normal.
The new regimen allows serum alanine aminotransferase and aspartate aminotransferase levels to be measured every 2 to 4 weeks during the first 6 months of therapy and then periodically at clinically relevant intervals.
The schedule should be reinitiated on dose up-titration to 200 mg three times daily.
The previously approved schedule called for liver function tests to be performed every 2 weeks for the first 6 months of therapy, every 4 weeks for the next 6 months, and every 8 weeks thereafter.
High-Concentration Topical Capsaicin for Lasting Pain Relief
The FDA approved orphan drug status for a high-concentration topical capsaicin product, TQ-1018 (TheraQuest Biosciences, LLC), for the management of postherpetic neuralgia. The medication is applied in conjunction with a local topical anesthetic and is designed to provide pain relief lasting weeks to months.
The products currently available for this indication are low-concentration topical capsaicin products and are not approved for the treatment of neuropathic pain. Three or four daily applications provide only modest relief of the condition.
Section Description
Medication Update alerts readers to new drug approvals and other timely drug information. Healthcare providers should not make clinical decisions from these announcements, as they are not comprehensive.