For routine inquiries, reporting an adverse drug event or to obtain other technical information, call (800) 521-5169 between 9:00 a.m. and 7:00 p.m. EST. For emergency medical information we are available 24 hours.
Drug Safety Q & A
What is an adverse event?
Any undesirable and/or unintended event that is associated with the use of a drug or biological product in humans whether or not considered product-related. Example: Taking a prescribed medication and experiencing a rash.
When can adverse events (AE) occur?
- An AE can occur in professional practices
- An AE can occur from drug abuse
- An AE can occur from a drug overdose, either accidental or intentional
- An AE can occur from drug withdrawal
- An AE can occur as a result of any failure of expected pharmalogical action (lack of effect, ineffective, subpotent)
- An AE can result from a medication error - Any preventable event that may cause or lead to inappropriate me
Why report an adverse event?
- In order to document and maintain patient safety Bedford Laboratories wants all adverse events reported both non-serious and serious events. Reports should be submitted as soon as possible after the adverse event occurs (ideally within 24 hours).
- Although it is helpful to have as much information as possible about an adverse event when submitting a report, reports should be submitted even if all details of the incident are not yet known.
How do I report an adverse event?
- Visit www.fda.gov/medwatch or call 1-800-FDA-1088
- Call Bedford Laboratories' Technical Support at 1-800-521-5169
Patients experiencing a medical emergency should contact their doctor or go to the emergency room as soon as possible.