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

Intelence is a tablet available only by prescription. It is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke. It is used to control HIV infection in adults and must be used in conjunction with other HIV medications. Intelence is for patients who have previously received treatment for HIV-1 and showed resistance to NNRTIs and protease inhibitors.

The clinical trials revealed that Intelence does carry a slight risk for serious skin reactions such as Stevens Johnson Syndrome (SJS), hypersensitivity reaction and erythema multiforme.

More than 200 medications have been linked to SJS and its more severe form, toxic epidermal necrolysis (TEN), most commonly ibuprofen, antibiotics and anti-seizure medications. SJS and TEN are severe expressions of a simple rash known as erythema multiforme. As the condition worsens, the rashes blister over causing the skin to peel off. Mucus membranes, such as the mouth and eyes, can blister over causing dehydration, infection, blindness and even death.

Patients taking medication, including Intelence, should be aware of the potential life-threatening risk of SJS/TEN

SOURCE: Stevens Johnson Syndrome › HIV treatment linked to slight risk of SJS/TEN