Health Canada

Health Canada issued the warning based on adverse event reports in Canada and other countries of consumers using Champix suffering suicide-related events or the worsening of existing psychiatric disorders. The new warning says the drug should be discontinued and a doctor consulted immediately if caregivers or family members notice atypical behaviors in Champix users or if users develop a skin rash. SJS begins as a rash that blisters over causing the skin to peel off. The eyes, mouth and internal organs can also be affected, causing serious problems including dehydration and ocular problems.

In May 2008, Pfizer updated its safety information on Chantix to warn of possible serious psychiatric symptoms. In 2009, the FDA announced it was evaluating Chantix again, this time for additional side effects including serious skin reactions and accidental injury. As a result, the FDA placed a black box warning on the drug, the agency’s strongest safety warning, because of the risk of depression, suicidal thoughts and suicidal actions.

SOURCE: Stevens Johnson Syndrome › Health Canada issues stronger warnings about Chamtix,Chantix

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