The European Agency for the Evaluation of Medicinal Products (EMEA) has issued an urgent safety restriction on Viramune (nevirapine), Boehringer Ingelheim's AIDS drug, after receiving numerous reports of cutaneous and hepatic reactions.

The reactions, which have sometimes been fatal, have been associated with risk factors such as lack of adherence to dosing regimens and failure to promptly seek evaluation when adverse reactions first appear. Most cases of hepatitis occurred within the first 8 weeks of treatment, the agency says. The EMEA calls the first 8 weeks of therapy "critical," and recommends that during that time physicians closely monitor patients for signs of skin reactions, hepatitis, and hepatic failure. They also recommend that initial dosing regimens be closely adhered to. If a serious cutaneous reaction, a hypersensitivity reaction, or hepatic complications do develop in a patient who is taking nevirapine, treatment should immediately be terminated.

Source Medscape