Tibotec Therapeutics

Early this year, Intelence was approved by the the Food and Drug Administration (FDA) for use in the treatment of HIV. At that time, data indicated a slight risk of SJS.

SJS, and its most severe form, toxic epidermal necrolysis, TEN, are identified by a rash on the skin that blisters over causing the skin to peel off in sheets. The condition is extremely painful and often requires hospitalization to treat the open wounds on the skin, mouth, eyes and other mucous membranes. Complications include infection, dehydration, vision problems, organ dysfunction and death.

SJS and TEN is a severe adverse reaction to medication. Some of the dugs most commonly associated with SJS and TEN include ibuprofen, antibiotics, and anti-seizure and anti-viral medicines.

Tibotec Therapeutics, in cooperation with the (FDA), issued a Dear Healthcare Professional Letter informing them that the WARNINGS and PRECAUTIONS sections of the drug information was updated to include warnings of severe skin and hypersensitivity reactions from use of Intelence (etravirine).

The letter urged health care providers to discontinues the medication immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop including but not limited to severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, and eosinophilia.

A delay in stopping the treatment after the onset of a severe rash may result in a life-threatening reaction.

SOURCE: Stevens Johnson Syndrome › HIV drug linked to deadly skin condition