Drug Alerts & Adverse Event Reporting
Xultophy 100/3.6 is a combination insulin indicated for adults with Type 2 Diabetes Mellitus. It is associated with an increased risk of acute pancreatitis and a potential risk of medullary thyroid carcinoma. Clinicians should refer to the Xultophy 100/3.6 REMS(51 KB PDF) when prescribing this medication (link).
Receive Drug Alerts
The AAFP has partnered with PDR Drug Alerts(www.pdr.net) to help you receive FDA-mandated and product-related patient safety alerts as soon as they are issued.
Features of PDR Drug Alerts include:
- Ability to appoint a family medicine team member to manage practice alerts
- Free for U.S.-based prescribers
- Traditional "dear doctor letter" (DDL) sent when online alert has not been reviewed within 72 hours (weekends not included)
- Email addresses kept secure and confidential
- Access to 12-month alert history master file
- No advertisements
- Information paid for by manufacturers required by the FDA to deliver safety alerts
- Exclusive specialty-specific service fulfilling FDA guidance for electronic delivery of drug warnings
Adverse Event Reporting
Using RxEvent, U.S. physicians and other health care providers can easily and effectively report adverse drug events. This service is a collaboration of medical professional insurance carriers and governmental experts.
Features of RxEvent include:
- Easy-to-use, standardized report form with pre-populated information
- Minimal required questions
- Prompt acknowledgment sent upon submission of a report
RxEvent has been established for use by U.S. health care professionals for reporting adverse events on U.S.-distributed drugs only.
ADVERSE DRUG EVENTS REPORTING
U.S. health care professionals may report adverse events on U.S.-distributed drugs only.