AUTH/2484/2/12: Therapist v Sanofi (Clexane) — medical information request from member of the public (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2484/2/12
Parties	Therapist v Sanofi
Product	Clexane (enoxaparin)
Issue	Alleged obstruction/refusal to provide information about timing of injection prior to a long flight (personal medical enquiry)
Applicable Code year	2011
Clauses considered	9.1, 22.2, 22.3
Panel decision	No breach of the Code
Complaint received	29 February 2012
Case completed	11 April 2012
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A clinical hypnotherapist/psychoanalyst/behavioural therapist phoned Sanofi’s medical information department about his possible personal use of Clexane (enoxaparin) before a nine-hour flight (and long car journeys).
He asked how long before travel he should inject Clexane and said Sanofi had “lots of data” but would not share it with him.
He said his GP and pharmacist “had no idea what time parameter to use” and that being told to have his doctor call was difficult.
Sanofi explained the SPC did not include a dosing regimen for prevention of in-flight thrombosis and that Clexane did not appear indicated for that circumstance.
Sanofi told the caller it could not comment on his personal medical situation and advised him to consult his own doctor or pharmacist; it offered to provide information to the doctor/pharmacist if they contacted Sanofi directly.

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No breach of the Code was ruled.
The Panel found Sanofi handled a personal medical enquiry appropriately by referring the caller back to a health professional and not providing product use information to the caller.

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