Letters
Safety of thalidomide
EDITOR, - C L Crawford has raised some questions about the prescription of thalidomide on a named patient basis to patients with leprosy in Britain.1 He wrote to me when I was chairman of the Committee on the Safety of Medicines to ask what information a supplier is required by law to provide with thalidomide when supplying the drug to a doctor for prescription to a named patient. According to the Medicines (Labelling) Regulations 1976 (regulations 11(1)(b)(i) and 11(1)(b)(ii), suppliers are required to provide information on the containers and packages of a medicine supplied for a named patient prescription but are not required to give details of contraindications, warnings, and precautions. The patient should be told of contraindications, warnings, and precautions by the prescribing doctor, who is entirely responsible for his or her actions when prescribing an unlicensed medicine.
Crawford also asked for advice about the clinical management of patients
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BMJ 1994 308: 1437.[Extract] [Full Text]
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