Decision report 201005378

Summary
Mr C was HIV-positive and was prescribed an anti-retroviral drug, efavirenz, by healthcare professionals at the board. Mr C was told that the potential side-effects of the drugs included dizziness, light-headedness, skin rash and vivid dreams or nightmares. After taking the initial dose, Mr C experienced very distressing mental changes including depression, paranoia, suicidal thoughts and violent thoughts. Mr C complained that he should not have been prescribed the drug in light of his history of mental ill health and that he had not been warned that he might suffer from serious mental change.

After taking advice from one of our medical advisers, we found that Mr C's history of mental ill health was not a reason to avoid the drug, which was a first choice of drug by practitioners in the treatment of HIV because of its effectiveness. We also found that, although healthcare professionals had discussed the main side effects with Mr C, he was not told that he might suffer from serious mental change but we considered this to be reasonable because it was such a rare side-effect. However, we considered that the information provided to patients about the side-effects could be better.

Recommendation
We recommended that the board:
• review the information provided to patients about the potential side-effects of efavirenz.