Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Name of policy document:
- ARM 49: Request to Reclassify a Product from POM to P -
Voltarol Pain-eze tablets
- Deadline for response:
- 4 January 2008
Background: This consultation sought views on the reclassification from POM to P of Voltarol Pain-eze tablets. Voltarol Pain-eze tablets are indicated for the short term relief of headache, dental pain, period pain, rheumatic and muscular pain, backache and the symptoms of colds and flu, including fever. The active ingredient is diclofenac potassium.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
ARM 49: REQUEST TO RECLASSIFY A PRODUCT FROM
POM TO P - VOLTAROL PAIN-EZE TABLETS
The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on consultation ARM 49.
The proposal is to change the prescribing of Voltarol (Diclofenac) at a low dose from POM to P. It is argued that it is no different from ibuprofen and safer than aspirin in terms of its toxicity profile. However, there is no doubt that studies of the gastrointestinal toxicity of diclofenac have consistently shown it to have a higher relative risk than ibuprofen. The College accepts that it is dose dependent and that the proposed dosage is at the lower end, but the proposal to make it P rather than POM could well be taken by consumers as an indication of greater safety.
In addition, there are also concerns about increased thrombotic risks with these compounds and, again, diclofenac appears less safe than ibuprofen. Other adverse effects of diclofenac include renal dysfunction and fluid retention.
Overall, the College accepts that these effects will probably be diminished with the dose levels proposed. However, we believe that prudence would suggest that there are already a number of analgesic alternatives available for P and GSL prescribing, including ibuprofen. In our view, it would be better to leave the prescribing of diclofenac to general practitioners who will have a much better awareness of each patient's medical history and, therefore, the potential for drug toxicity. If it is to be approved, the College would support the Commission for Human Medicines’ proposal that the company should be required to collect and present high quality post-marketing surveillance data for a considerable period after its transfer to P prescribing.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[3 January 2008] |
