§ Mr. David Marshallasked the Secretary of State for Social Services what side effects have been reported to the Committee on Safety of Medicines in respect of Minoxidil; when it was approved for prescription-only use; if he has any plans to permit its sale without prescription; and if he will make a statement.
§ Mr. HayhoeThere have been 46 reports of suspected adverse drug reactions associated with Minoxidil received by the Committee on Safety of Medicines and these are set out in the table. It should be noted that, such a report does not necessarily indicate a causal relationship between a product and the reported reaction, and considerable caution should be exercised in interpreting these numbers in the absence of data on the prescription volume and other relevant factors.
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Reports to the Committee on Safety of Medicines on adverse reactions associated with Minoxidil since June 1978* Reaction Reports Face oedema 1 Hair abnormal 1 Hirsutism 9 Hypertrichosis 3 Oedema periorbital 1 Rash maculo-papular 1 Rash pustular 1 Urticaria 1 Headache 1 Mouth dry 1 Vasospasm 1 Conjunctivitis 1 Vision loss temporary 1 Deafness 1 Diarrhoea 3 Haemorrhage rectal 1 Vomiting 1 Cirrhosis biliary 1 Gynaecomastia 3 Hepatic function abnormal 1 Jaundice cholestatic 1 Hyponatraemia 1 Pericardial effusion 1 Myocardial infarction 1 Pericarditis 1 Cardiac arrest (death) 1 Abnormal bruising 1 Peripheral ischaemia 1 Lymphadenopathy 1 Ascites 1 Granulomatous lesion 1 Pain 1 * Date of first report. Minoxidil was granted a product licence in 1979, as a prescription-only medicine, and I have no plans to change this.