Cephalon, makers of Treanda, has filed documents with the Securities and Exchange Commission this week stating it will update its prescribing information for the Treanda drug to include a warning of the possibility of SJS when used with allopurinol, a medication used to treat excess uric acid in the blood plasma, according to the Philadelphia Business Journal.

According to the documents, two patients treated with Treanda and allopurinol were diagnosed with SJS. One of the two died.

SJS is a rare but life-threatening condition in which a rash forms on the skin and blisters over. The skin peels off, leaving the skin exposed to infection. Blisters also can form on mucus membranes such as the eyes and mouth, which can lead to dehydration and vision problems. More than 200 medications have been linked to SJS.

“Although the relationship between Treanda and Stevens Johnson Syndrome cannot be determined, there may be an increased risk of severe skin toxicity when Treanda and allopurinol are administered concomitantly,” Cephalon stated in its filing, adding that allopurinal is known to cause the syndrome.

The updated prescribing information is expected to be implemented in early May.

SOURCE: Stevens Johnson Syndrome › Cancer drug’s prescribing information to include warning of SJS

Modafinil (Provigil) is approved by the FDA to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea. Modafinil (Provigil) also has been shown effective in the treatment of depression, cocaine addition, Parkinson’s Disease and schizophrenia, though the FDA has not approved the drug for those conditions. It also was thought to be an effective treatment for Attention-Deficit Hyperactivity Disorder (ADHD), however in 2006 it was rejected by the FDA for use by children for ADHD. Cephalon now discourages the drug’s use in children for any purpose.

Since December 1998, when Modafini (Provigil) was introduced to the market until January 30, 2007, seven cases of seven cases of severe cutaneous adverse reactions to the medicine were reported to the FDA. Those cases included SJS and its more severe form, toxic epidermal necrolysis (TEN).

SJS and TEN has a reported incidence rate of about one case per million people each year. It is most often caused by an adverse reaction to medication. Medications that have been linked to SJS and TEN include NSAIDS (non-steroidal anti-inflamatory agents), anti-seizure medications and some antibiotics.

SOURCE: Stevens Johnson Syndrome › Stimulant drug added to list of meds that can cause SJS/TEN