Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The FDA recently approved safety labeling revisions for darunavir tablets, also known as Prezista, to warn of adverse reactions including skin rashes and Stevens Johnson Syndrome (SJS), according to MedScape.

Darunavir, manufactured by Tibotec, belongs to a class of anti-HIV drugs called protease inhibitors (PI). It works to prevent cells infected by HIV from producing new virus, thus reducing the amount of virus in the body. Darunavir must be coadministered with 100-mg ritonavir and with other antiretroviral agents. It was approved by the FDA in June 2006 for HIV-positive adults who were treatment-experienced.

Last October, darunavir was approved for HIV-positive individuals beginning treatment. The medication has proven effective for patients who are not likely to respond to older PIs and for those who are starting antiretroviral therapy for the first time.

SJS and its more severe form, toxic epidermal necrolysis (TEN), are serious adverse reactions to medication. The reaction begins with a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes in the eyes and mouth also can blister over, leading to dehydration, infection, blindness, and even death. More than 200 medications have been linked to SJS and TEN, including NSAIDs such as ibuprofen, antibiotics and anti-seizure medication.

Other warning included in the labeling revisions for darunavir include warnings of potential drug-drug interactions and pregnancy risk. Darunavir should not be taken with dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. John’s Wort, lovastatin, simvastatin, or rifampin.

Darunavir also should be taken during pregnancy only if the potential benefit justifies the potential risk, according to the report. Mothers on darunavir should not breast feed, and children younger than 3 should not take darunavir.

This entry was posted on Friday, January 23rd, 2009 at 8:00 am and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.