ADHD Drugs Catch a Break

A skin patch, developed in collaboration with Noven Pharmaceuticals (NOVN Quote - Cramer on NOVN - Stock Picks) is now under review by the FDA. The agency is expected to act in early April on the product called Daytrana, which would treat children ages 6 to 12.

Shire also is working with New River Pharmaceuticals (NRPH Quote - Cramer on NRPH - Stock Picks), whose drug NRP104 is meant for children from 6 years old to 12. The FDA began reviewing the drug in January.

Adderall XR and Adderall already have a black box warning, alerting doctors and patients to the potential abuse of amphetamines, which could cause heart damage or sudden death. These drugs are stimulants, as are J&J's Concerta, Novartis' Ritalin and generic forms of Ritalin.

The Shire-Noven product contains the same ingredient found in Ritalin and Concerta. The Shire-New River compound contains an amphetamine derivative, which, the companies say, has a reduced risk of addiction.

Cephalon's Sparlon isn't considered a stimulant. Neither is Lilly's Strattera, a drug on the market since 2003. Strattera carries a black box warning that it could cause suicidal thinking among adolescents and children, as well a strong caution about potential liver damage.

Safety of Millions

On Wednesday, the panel of medical experts wrestled with issues that affect not only ADHD drugs but also other many other drugs -- how to balance a concern for safety vs. a desire to find treatments for difficult diseases.

Some panel members worried that a black box warning would dissuade patients from seeking treatment for ADHD, whose symptoms include restlessness, inability to concentrate for long periods of time and impulsiveness.

The balancing act with ADHD becomes more complicated because so many children are involved and because some critics say these drugs are overprescribed.

A recent study by Medco Health Solutions (MHS Quote - Cramer on MHS - Stock Picks) said the number of people 19 years old and younger using ADHD drugs in the U.S. grew 82% between 2000 and 2005. The number of adults between ages 20 and 44 taking ADHD drugs surged 139% during the same period.