Reporting Adverse Drug Reactions
Please report adverse drug reactions and withdrawal reactions to APRIL for use in our campaigns:
Please report to RxISk www.rxisk.org A new independent data base for reporting and finding information.
Founding members of RxISK see the need for independent data collection of ADRs.
They include Dr David Healy, Dr Derelie (Dee) Mangin, Dr Kalman Applebaum, Dr Ralph Edwards, Dr Brenda Gallie, Robert Whitaker, Dr Joanna Le Noury, Dr Nancy Oliviera.
Be assured the submission of your experience is of a great value to us and to RxISK and will help others. We anonymise your experience and use the information in our campaigning for safer drugs and awareness of psychiatric side effects.
You should also please report to the UK Regulator using the Yellow Card System for reporting adverse drug reactions (ADRs) www.yellowcard.gov.uk
Millie Kieve (founder of APRIL) was Chair of the Advisory Group to the Evaluation of Patient Reporting using the Yellow Card System in the UK. The Evaluation was undertaken by Professors and researchers at Nottingham, Liverpool, John Moores, Aberdeen Universities and the Drug Safety Research Unit.
the full report is now available: http://www.hta.ac.uk/project/1628.asp
Patient reporting is valuable in highlighting signals of ADRs and this was confirmed by over 40 new signals being found in the recent Evaluation
Patients, carers and health professionals may report to the Medicines and Healthcare Products Regulatory Agency (MHRA): Report side-effects that are serious enough to have an adverse effect on your life in any way.
You can report to the UK regulator by phone, on the Internet or by mailing a form obtained from the pharmacist or direct from the MHRA. Make sure it is a patient YellowCard as some pharmacists tear one out of the BNF a medical book for doctors that lists all the drugs available in the UK.
Report on line using the above link (no need to register) or telephone to report or to request a Patient YellowCard reporting form
Telephone: 0808 100 3352 between 10am - 2pm
US Regulator
Worldwide reports accepted from patients carers and health professionals: Food and Drug Administration (FDA)
www.fda.gov/medwatch/report.htm
http://www.fda.gov/medwatch/report/.htm (this site has extra info for consumers)
Other websites collecting ADRs
The following web site contains over 2,800 press reports involving SSRI, SNRI and other antidepressants. Please add your own or reports you find for inclusion. The information on this web site, has helped to influence the FDA to strengthen warnings about the adverse effects of antidepressants.