Announcements
Osteonecrosis with CART
The European Medicine Agency’s Committee for Medicinal Products
for Human Use (CHMP) has advised that information regarding osteonecrosis
should be included in sections 4.4. (special warnings) and 4.8 (undesirable
effects) of the summaries of product characteristics of all antiretroviral
medicinal products. SPCs are being updated with the following statement: “Although
the aetiology is considered to be multifactorial (including corticosteroid
use, alcohol consumption, severe immunosuppression, higher body mass
index), cases of osteonecrosis have been reported, particularly in patients
with advanced HIV disease and/or long-term exposure to combination antiretroviral
therapy (CART). Patients should be advised to seek medical advice if
they experience joint aches and pain, joint stiffness or difficulty in
movement.” |
The
Pharmaceutical Journal