Drug ADR Research Articles

SAT0484 Incidence of tuberculosis, serious infections, and lymphoma in patients with rheumatoid arthritis who received biologics and non-biologic treatment in taiwan

BackgroundThe risk of tuberculosis (TB), infection and lymphoma is a major concern for anti-tumor necrosis factor (anti-TNF) therapies. However, limited comparative data about the rates in Asia and TaiwanObjectivesTo assess...

Adjunctive Corticosteroid to Counteract Adverse Drug Reactions from First-Line Antituberculous Drugs

Inclusion of H and R in anti-TB drug regimen is critical to highly effective short-duration TB treatment. Completion of antiTB therapy is severely compromised when H or R are removed from treatment regimens. Unfortunately, H or R induces ADRs and physicians may initiate desensitization therapy to promote anti-TB therapy completion. When desensitization therapy does not mitigate the anti-TB ADRs, anti-TB therapy is often delayed. Previous studies suggest that corticosteroid adjust therapy may improve anti-TB drug ADR management. In this study, patients receiving prednisolone to counteract ADRs, despite desensitization therapy, display modest benefits in anti-TB treatment completion.

87 Drug interactions and ADR

87 Drug interactions and ADR

Suspected ADRs of new drugs underreported

Suspected ADRs of new drugs underreported

Suspected ADRs of new drugs underreported

Suspected ADRs of new drugs underreported

Changing the Review Process: The View of the Japanese Ministry of Health and Welfare

On the basis of the discussion at the Committee for Drug Safety Ensuring Measures, the Japanese Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law (PAL) and related laws, and is reforming its review system for new drugs. Under the amendments, good clinical practice (GCP) is mandatory for all clinical trials, Phase 1 protocols are reviewed within 30 days of submission, and advice on all protocols is provided by the Organization for Drug ADR Relief, RD strengthen compliance reviews of documents for approval, reexamination, and reevaluation applications; improve the quality of the review process; and bolster the collection of data on adverse drug reactions.The drug organization con...