Biologies adverse events

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

Anakinra is the first biologic drug that has been developed specifically as an interleukin (IL)-l receptor antagonist and is derived from an endogenous IL-IRa. The drug blocks the activity of IL-1 in synovial joints, reducing the infiammatory and joint destructive processes associated with rheumatoid arthritis. It is administered subcutaneously and is generally well tolerated. Injection-site reactions are the most commonly reported adverse event. 

Bexarotene is a member of a subclass of retinoids that selectively activate rehnoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of rehnoic acid receptors (RARs). After oral administration bexarotene is rapidly absorbed. Bexarotene is thought to be eliminated primarily through the hepatobiliary system. It is approved for the treatment of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Adverse events possibly related to treatment are lipid abnormalities, hypothyroidism, rash, and blood dyscrasias. 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

To evaluate the biological consequences of antibodies, patients with positive responses should be monitored for their impact on the pharmacokinetic and pharmacodynamic effect of the therapeutic protein. Also the effect on adverse events and possible neutralization of the endogenous protein, in cases where human proteins are administered at pharmacological doses, should be monitored. When the consequences of the immunogenicity are known, the risk can be established. 

---