Gardasil Listed As Black Triangle Drug -New drugs and vaccines under intensive surveillance

MHRA

January 2011

United Kingdom

The Medicines and Healthcare products Regulatory Agency (MHRA) was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.

What are Black Triangle drugs (▼)?
When medicines come onto the market, we have relatively limited information about their safety from clinical trials in the UK. These trials generally involve only small numbers of eligible patients who take the medicine for a relatively short period of time. Therefore, patients in clinical trials may not be fully representative of those who will use the medicine when it is marketed.

Only when large numbers of patients have taken a medicine are rare or long-term adverse effects identified. Therefore, effective surveillance after marketing is essential for the identification of rare adverse effects, and to ensure that appropriate action is taken.

New medicines are intensively monitored to ensure that any new safety hazards are identified promptly. The Commission on Human Medicines (CHM) and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol (▼). This symbol appears next to the name of a relevant product:

• the British National Formulary (BNF)
• in the British National Formulary for Children (BNFC)
• in the Nurse Prescribers’ Formulary (NPF)
• in Monthly Index of Medical Specialities (MIMS)
• in the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium
• on advertising material
• in Drug Safety Update

This section provides information about reporting suspected adverse drug reactions for healthcare professionals. Information for patients is available in the ‘Patient reporting of suspected adverse drug reactions’ section (please see ‘Related information on the right of this page’).

Read the Documents:

Gardasil is listed in the second December 2010 PDF.  SV