Safety warnings from regulatory agencies in a Web search up to April 1, 2009.
| Regulatory Agency/Source | No .of Items Found | Summary of Warnings and Conclusions |
|---|---|---|
| US Food and Drug Administration38 | 70 | The abatacept label information highlighted the increase in serious infections, lymphoma, and lung cancer in patients taking abatacept compared to placebo. Label also included warning about using abatacept concurrently with anti-TNF therapy. No significant benefit in terms of efficacy was found with concurrent therapy and the concerns about an increase in infections and serious infections warranted a warning that abatacept should not be administered to patients on concurrent anti-TNF therapy |
| European Medicines Agency39 | 22 | The European Public Assessment Report’s Scientific Discussion report39 highlighted signals of a possible increased risk for infection and autoimmune disorders that will need to be further investigated as well as malignancies, given abatacept’s mechanism of action. The report concluded that ongoing pharmacovigilance is needed to address concerns about “potential rare and unexpected severe adverse effects of abatacept” |
| Current Problems in Pharmacovigilance and Drug Safety Update, UK | 0 | — |
| Australian Adverse Drug Reactions Bulletin | 0 | — |