The Yellow Card Scheme acts as an early warning system for the identification of previously unrecognised adverse reactions. It also provides valuable information on recognised adverse reactions, allowing the MHRA to identify and refine the understanding of risk factors that may affect the clinical management of patients. The value of the scheme has been demonstrated many times and it has helped to identify numerous important safety issues.
The following table shows safety issues which Yellow Card reports have helped identify:
| Year | Medicine | Adverse Reaction | Resulting action or advice |
|---|---|---|---|
| August 2011 | Lei Gong Teng (Tripterygium wilfordii) | Risk of serious side effects | Healthcare professionals are asked to remain vigilant and advise anyone currently using this product to stop taking it |
| January 2011 | Sitaxentan (Thelin) | Worldwide withdrawal from the market | Worldwide withdrawal from the market |
| June 2010 | Rivastigmine (Exelon) | Medication errors | Warning issued in Drug Safety Update (DSU) |
| December 2009 | Finasteride (Proscar, Propecia) | Potential risk of male breast cancer |
Product information for prescribers updated |
| June 2009 | Antipsychotics | Venous thromboembolic events |
Product information for prescribers updated |
| April 2009 | Antiepileptics | Adverse effects on bone | Vitamin D supplementation should be considered for at risk patients |
|
January 2009/ |
Tacrolimus (Advagraf and Prograf) |
Risk of serious medication errors |
Prograf and Advagraf are not interchangeable and should not be substituted without careful therapeutic monitoring |
| December 2008 | Hedrin (dimeticone) | Hair fire accident | Warning to keep hair away from fire |
| April 2008 |
Unlicensed herbal product marketed for diabetes |
Dangerous advice to patients to stop taking prescribed dedication |
|
| Febuary 2008 | Varenicline (Champix) | Depression, suicidal thoughts and behaviour | Warnings issued and monitoring of patients with history of psychiatric illness advised |
| November 2007 | St John’s Wort, Hypericum perforatum | Interaction with all antiepileptics |
Current warnings about interactions should extend to include all antiepileptic medicines |
| November 2007 | Aristolochia in Chinese herbal remedies | Renal failure, transitional-cell carcinoma | Reminder of warnings, and ban |
| 2006 | Linezolid (Zyvox) | Optic neuropathy | Improved warnings and monitoring recommendations |
| 2006 | Chinese herbal remedy: Polygonum multiflorum | Hepatotoxicity | Warnings |
| 2006 | Black cohosh (Cimicifuga racemosa) | Hepatotoxicity | Improved warnings |
| 2004 | Rosuvastatin (Crestor) | Rhabdomyolysis | Revised dosing instructions and improved warnings |
| 2003 | Warfarin | Interaction with cranberry juice leading to changes in INR values and bleeding episodes | Warnings |
| 2003 | Aspirin | Reye’s Syndrome in children under 16 years | Statutory label warning |
| 2003 | Kava-kava (Piper methysticum) | Hepatotoxicity | Supply prohibited in the UK |
| 2002 | Ergot derived dopamine receptor agonists; pergolide (Celance), bromocriptine (Parlodel), cabergoline (Cabaser), lisuride | Fibrotic reactions | Class warnings added to product information |
| 2001 | Bupropion (Zyban) | Seizures | Improved warnings and revised dosing instructions |
| 2000 | St John’s wort (Hypericum perforatum) | Interactions including with oral contraceptive pill | Improved warnings |
| 2000 | Cisapride (Prepulsid, Alimix) | Serious cardiovascular reactions | Use of Cisapride suspended in the UK* |
| 1999 | Human clottable protein concentrate (Quxil) | Fatal neurotoxic reactions following unlicensed using in neurosurgery | Improved warnings |
| 1999 | Aristolochia in Chinese herbal remedies | Renal failure | Aristolochia banned |
| 1998 | Isotretinoin (Roaccutane) | Psychiatric reactions | Improved warnings |
| 1998 | Sertindole (Serdolect) | Sudden cardiac death | Medicine withdrawn§ |
| 1997 | Clozapine (Clozaril) | GI obstruction | Improved warnings |
| 1997 | HIV protease inhibitors | Hyperlipidaemia, lipodystrophy | Improved warnings and monitoring recommendations |
| 1996 | Alendronate (Fosamax) | Severe oesophageal reactions | Warnings and revised dosing instructions |
| 1995 |
Cyproterone acetate (Cyprostat, Androcur) |
Hepatotoxicity | Restricted indications and added requirement for hepatic function monitoring |
| 1995 | Tramadol (Zydol) | Psychiatric reactions | Warnings |
| 1995 | Cyproterone acetate (Cyprostat, Androcur) | Dose-related hepatotoxicity | Restricted indications, requirement for monitoring of liver function |
| 1995 | Vigabatrin | Visual field defects | Change of recommended dosage, range of indications and addition of warnings |
| 1995 | Quinolone antibiotics | Tendonitis, tendon rupture | Improved warnings |
| 1995 | Tacrolimus (Prograf) | Hypertrophic cardiomyopathy | Warnings, dose reduction and monitoring requirements |
*Cisapride licences have been cancelled
§Sertindole was reinstated in 2002 with increased warnings
Information on the nature of risk and benefit to healthcare professionals and patients helps allow informed choices to be made about treatment options and in the management of ADRs should they occur.
Patients and health professionals reporting suspected adverse drug reactions to the Yellow Card Scheme help contribute to these important processes. Suspected reactions can be reported online at www.mhra.gov.uk/yellowcard
