FDA Panel Rejects Cephalon's Sparlon

Sparlon contains the ingredient modafinil, the same ingredient found in Provigil, a sleep-disorders drug that also is Cephalon's best-selling product. Sparlon contains a higher dose of the ingredient than does Provigil.

Provigil doesn't have any black box warnings nor does it have any alerts for dangerous skin problems.

No ADHD drug has such a warning for the dangerous skin rashes. Strattera, from Eli Lilly (LLY), has a black box warning about suicidal thinking in adolescents. The label also alerts patients to potential liver damage.

Adderall and Adderall XR, from Shire PLC (SHPGY) have a black box regarding potential amphetamine abuse.

Last month, another FDA advisory committee recommended that all stimulant-type ADHD drugs carry a black box warning for cardiovascular risk. The vote was 8-7, with one abstention, covering drugs such as Shire's medications, Ritalin from Novartis (NVS), generic versions of Ritalin, and Concerta from Johnson & Johnson (JNJ).

Several smaller brands also would be affected because they are stimulants. Neither Strattera nor Cephalon is viewed as a stimulant by the FDA.

Stevens-Johnson syndrome played a role in the FDA's requesting the removal from the market of Bextra, a Pfizer (PFE) arthritis drug that was withdrawn last April.

Bextra's label already had a black box warning for this disease when the FDA asked Pfizer to pull it, saying the drug's risks outweighed its benefits. The agency also cited a "potential increased risk" of serious cardiovascular injury in asking Pfizer to withdraw Bextra.

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