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Volume 506: debated on Monday 22 February 2010

To ask the Secretary of State for Health whether he has made an estimate of the number of people there are in England who have been adversely affected by the drug Primodos. (317688)

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme; the yellow card scheme. Approximately 25,000 reports of ADRs are reported to the MHRA/CHM through this scheme each year. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. It is not possible to calculate from yellow card data the number of people who have been adversely affected by a drug, as the scheme is associated with an unknown level of under-reporting.

Reporters of ADRs will often cite the active substance(s) rather than a particular brand name. As of 12 February 2010, there are three retrospective cases for Primodos and 3,540 that have been recorded in our database for the combined drug substances norethisterone and ethinylestradiol.

To ask the Secretary of State for Health what steps his Department has taken to assess the needs of those adversely affected by Primodos; and if he will make a statement. (317689)

We have made no assessment. It is for local clinicians and multi-disciplinary teams to assess the health and care needs of people adversely affected by Primodos.