UK-CAB 26 – TB and HIV – reporting adverse drug reactions – Theratechnologies

25 July 2008

Programme

09.45 – 10.00 Welcome, announcements
10.00 – 10.15 Feedback from UNGASS meeting, New York – Winnie Sseruma, UNGASS delegate
10.15 – 10.45 Feedback from the Resistance Workshop, Sitges – Simon Collins, HIV i-Base
10.45 – 12.15 Company meeting: Theratechnologies
12.15 – 13.30 Lunch
13.30 –14.30 Yellow card scheme for reporting side effects – Susan Kenion and Abidali Fazal, MHRA
14.30 – 14.45 Break
14.45 – 15.00 UK-CAB business
15.00 – 16.00 TB and HIV – Sanjay Bhagani, Royal Free Hospital
16.00 Close

Background reading

UNGASS

UNGASS meeting, June 2008

Tesamorelin

Tesamorelin (TH9507) is a treatment which reduces abdominal fat in patients with HIV-related lipodystrophy

Tesamorelin (TH9507) reduces abdominal fat in patients with HIV-related lipodystrophy: 52 week results

NEJM: Tesamorelin 26 week results

Theratechnologies

Video – how this drug works (works inAdobe Flash player)

Yellow Card scheme

The Yellow Card scheme is a system for reporting and monitoring adverse events (side effects) from newly licensed drugs. Both doctors and patients may report adverse events.

Yellow Card scheme – introduction

Guidance for public on reporting side effects PDF

From the MRHA website:

The Yellow Card Scheme is vital in helping the MHRA monitor the safety of the medicines that are on the market.

Before a medicine is granted a license so that it can be made available in the United Kingdom, it must pass strict tests and checks to ensure that it is acceptably safe and effective. All effective medicines, however, can cause side effects (also known as adverse drug reactions), which can range from being minor to being very serious. For a medicine to be granted a licence, the expected benefits of the medicine must outweigh the possible risks of the medicine causing adverse effects in patients. Sometimes, it is difficult to tell whether a possible side effect is due to a medicine, or something else. Even if it is only a suspicion that a medicine or combination of medicines has caused a side effect, we ask patients and health professionals to send us a Yellow Card.

Yellow Card reports that we receive on suspected side effects are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, in order to identify previously unidentified safety issues or side effects.

Information gathered from Yellow Card reports made by patients and health professionals is continually assessed at the MHRA by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, information is carefully considered in the context of the overall side effect profile for the medicine, and how the side effect profile compares with other medicines used to treat the same condition. The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimizes risk, while maximizing patient benefit.

In assessing the safety of medicines, the MHRA is advised by the Commission on Human Medicines (CHM), which is the Governments independent scientific advisory body on medicines safety. The CHM is made up of experts from a range of health professionals and includes lay representatives.

TB and HIV

Stop TB Stop TB Partnership

BHIVA TB/HIV coinfection guidelines

WHO manual on treatment of TB/HIV co-infection PDF

10 essential actions for effective TB infection control PDF

Financial support

The UK-CAB receives unrestricted funding from some pharmaceutical companies towards the direct costs of holding four meetings each year. This funding supports the travel and accommodation costs for members to attend from outside London, plus the cost of catering.

The content, programme and agenda for meetings is decided by the UK-CAB steering group in consultation with the wider membership. Funding is unconnected to meeting content.

We believe that manufacturers who currently develop and market medicines have a responsibility to actively engage with advocacy organisations and that HIV positive people and their advocates should be able to directly question manufacturers about the safety and efficacy of their products and proposals for future research.

For a list of companies that support the UK-CAB please see the “about us” page.

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Published: July 25, 2008
Last edited: August 13, 2013