← Back to Cases
PMCPA Case

AUTH/3239/8/19: Pharmacist v Colonis Pharma Limited – promotion of Melatonin Oral Solution and off-label implication

📅 8 March 2026 | 🖉 Anzal Qurbain
📊

Key facts

⌄
Case numberAUTH/3239/8/19
Case referencePharmacist v Colonis
ComplainantA pharmacist in a medicines optimisation team (university NHS foundation trust)
Respondent/companyColonis Pharma Limited
Product(s)Melatonin 1mg/ml Oral Solution
Material/channelOne-off mailed letter/launch notification (ref UK-CPL-121-008) to pharmacists/procurement/medicines optimisation teams and CCG medicines management teams
Key issuePromotion implying off-label use (including implication of use across a wide age range despite SPC paediatric restrictions) and omission of prominent warnings; incorrect prescribing information enclosure
Dates (received/completed if stated)Complaint received 13 August 2019; Case completed 20 December 2019; Mailing sent 25 June 2019; Corrective letter dated 24 July 2019
AppealNot stated
Code yearNot stated
Breaches/clausesClause 3.2; Clause 9.1; Clause 2
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI
📋

What happened

⌄
  • A pharmacist in a medicines optimisation team complained about a Colonis Pharma Limited letter (ref UK-CPL-121-008) which allegedly promoted off-label use of Melatonin 1mg/ml Oral Solution.
  • The product was indicated for the short-term treatment of jet-lag in adults; the Panel noted this indication appeared only once in the first sentence of the letter.
  • The letter was a one-off mailing sent on 25 June 2019 to 18,649 recipients including hospital pharmacists, procurement pharmacists, medicines optimisation teams and CCG medicines management teams.
  • The Panel noted the letter mainly discussed using the product in preference to unlicensed alternatives and stated it should be prescribed over unlicensed alternatives.
  • The Panel noted the letter included the statement “Can be used over a wide age range” in prominent coloured circles and larger font than the licensed indication.
  • The Panel noted the SPC stated safety and efficacy in children and adolescents (0–18 years) had not been established and the product should not be used in children and adolescents due to safety and efficacy concerns.
  • The Panel noted a schematic ranking options from low to high risk placed “UK licensed medicines used off-label” at the low-risk end.
  • The Panel noted incorrect prescribing information was supplied with the letter: it related to Melatonin 3mg film-coated tablets, while the letter promoted Melatonin 1mg/ml Oral Solution.
  • Colonis stated that, following MHRA correspondence and complaints, it sent an agreed corrective letter dated 24 July 2019 clarifying the licensed indication and safety restrictions (including paediatric restrictions) and included a copy of the SPC.
  • During consideration, the Panel noted the corrective letter stated that a reference citing a named CCG was not intended to suggest endorsement and apologised for referring to the CCG’s document without express permission; the Panel noted Colonis’ submission to Case AUTH/3221/6/19 did not include that appropriate permissions had not been obtained, and reminded that self-regulation relied on complete and accurate responses.
⚖️

Outcome

⌄
  • The Panel ruled the letter promoted Melatonin 1mg/ml Oral Solution for off-label use (Clause 3.2 breach).
  • The Panel ruled patient safety had been compromised by the promotion of off-label use and the lack of warnings (including that it should not be used in children and adolescents), and that high standards had not been maintained (Clause 9.1 breach).
  • The Panel ruled the letter brought discredit upon and reduced confidence in the pharmaceutical industry (Clause 2 breach).
🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value
£249/year
Annual — save £99
or
£29/mo
Monthly
Join Now — Instant Access
← All Cases Book a Free Compliance Call

📰 Weekly PMCPA Case Breakdown

One real case. One key lesson. Every week — free.

Subscribe Free