Detrol is just one of the medications that has been added to the Food and Drug Administration (FDA) quarterly report on treatments identified as a potential safety risk to patients. According to the report, Detrol, also known as Tolterodine Tartrate, is being evaluated by the agency after reports of patients diagnosed with Stevens Johnson Syndrome (SJS), a rare but life-threatening skin condition, after taking the medication.

SJS and its most severe form, toxic epidermal necrolysis (TEN), are severe adverse reactions to medications. More than 200 medications have been linked to the condition. Those who suffer from SJS or TEN experience rashes that blister over and cause the skin to peel off in sheets. Blisters can also form on the eyes, inside the mouth and on internal organs, causing ocular problems, dehydration, infection and sometimes death.

Other medications listed in the FDA’s quarterly report and investigated for a possible link to skin reactions include hydrochlorothiazide in combination with other products, sleep disorder medications modafinil (Provigil) and Armodafinil (Nuvigil), and smoking cessation drug Chantix.

The FDA reports that it is continuing to evaluate these issues to determine if there is need for regulatory action. In the interim, the FDA emphasizes that the listing of a drug and a potential safety issue does not mean that the medicines should not be prescribed nor that patients taking those drugs should stop taking the medication. Patients with questions about their medication should contact their health care provider.

Source: FDA

SOURCE: Stevens Johnson Syndrome › New drugs investigated for possible skin reactions

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