It may be helpful if I first clarify the data that I provided in my previous response of 14 January (DE379334). As you are aware, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 653 reports of suspected adverse drug reaction (ADR) reports associated with haloperidol through the Yellow Card Scheme.

All Yellow Card reports received are entered onto the MHRA’s database for rapid analysis by its scientists, pharmacists and medical assessors to determine whether an adverse reaction may be related to the drug.

When assessing whether a suspected adverse reaction is causally linked to the medicine prescribed to the patient, MHRA need to assess whether any other factors involved may have contributed to the adverse reaction. This might include other potential causes, such as an underlying disease for which the patient is being treated, or other medicines. MHRA do not categorise data as real or imaginary during this assessment.

The Yellow Card Scheme allows health professionals and patients to report suspected ADRs on a voluntary basis. In addition, there is a legal requirement for companies to report suspected ADRs to their products. The number of ADR reports associated with haloperidol received by the MHRA does not equate to the number of patients who have suffered suspected ADRs to Haloperidol as there is a level of under-reporting. Information on how to use haloperidol and the known side-effects, such as tardive dyskinesia, is available in the product information. The product information can be viewed on the website: www.emc.medicines.org.uk/medicine/17426/SPC/Haldol+10mg+Tablets/

As with all medicinal products, the MHRA continues to monitor the safety of haloperidol and will review potential safety issues in the light of any new evidence which may emerge from data sources such as data from the Yellow Card scheme, formal safety studies, published medical literature and information from pharmaceutical companies.

One of its key roles is to advise health care professionals about the safe use of medicines. However, the prescribing of any drug including information on treatment and possible side effects and your clinical care remains the responsibility of your doctor. They are in the best position to decide on the type of treatment that is most appropriate for you given their clinical expertise and their knowledge of your medical condition, and you may wish to discuss this matter with them further.

If you have any queries about this email, please contact me. Please remember to quote the reference number above in any future communications.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original letter and should be addressed to:

Section Head
Freedom of Information Unit
Department of Health
Room 334b
Skipton House
80 London Road
SE1 6LH

Email: xxxxxxxxxxxxxxxxxxxx@xx.xxx.xxx.xx

If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner (ICO) for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Department. The ICO can be contacted at:

The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely,