Bedford Laboratories®14 April 2014

Technical Support and Adverse Event Reporting

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.

Adverse Event FAQ

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 medication use or harm to a patient.

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, call 911 or go to the nearest emergency room as soon as possible.