Healthy Skepticism Library item: 13507

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Publication type: news

Advertising complaint - Actos (pioglitazone) - healthcare professional advertisement - January 2008
MHRA 2008 Mar
http://www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/Advertisinginvestigations/CON014509

Full text:

An advertisement for Actos published in January 2008 by Takeda for healthcare professionals in Pulse and GP was reviewed as part of the MHRA’s scrutiny of published advertising. The MHRA was concerned that claims relating to pioglitazone and cardiovascular risks did not reflect the balance of risks and benefits for the product as stated in the SPC.
Takeda withdrew the advertisement and agreed to publish a corrective statement.
Date case raised: 21 February 2008
Date action agreed: 19 March 2008
Date of publication: 3 April 2008
Corrective statement
The MHRA have asked Takeda UK Ltd to provide a corrective statement regarding the promotional content of an advertorial concerning Actos®▼ (pioglitazone HCl) which was commissioned by Takeda. The advertorial was published in a single edition of GP and Pulse in January 2008. The advertorial will not be used again.
The MHRA considered that the advertorial was inconsistent with the SPC as a claim was made about CV risk repeatedly throughout the advertorial which was felt to be inappropriate in the light of information in the SPC that states that the product may cause fluid retention which may exacerbate or precipitate heart failure. The MHRA viewed the information presented in the advertorial on the risks of heart failure to be insufficient in that the specific monitoring of patients for signs of fluid retention that may exacerbate or precipitate heart failure as given in the SPC were not specifically stated in the advertorial itself but only in the prescribing information at the bottom of the advertorial.
We would like to emphasise that Actos is contraindicated in patients with cardiac failure, or history of cardiac failure and patients should be observed for signs and symptoms or cardiac failure, weight gain or oedema. The MHRA judged that this advertorial was in breach of the Medicines (Advertising) Regulations in that it was misleading and did not encourage rational use of the product as the appropriate checks on patients were not specifically mentioned.
Takeda regrets this potential breach of the Advertising Regulations. As a company which seeks to operate to the highest ethical standards it has never been Takeda’s intention to mislead following the recent review of glitazones by Health Authorities. Takeda would like to take this opportunity to restate its commitment to compliance with the Advertising Regulations and with the ABPI Code of Practice.
Should you have any further questions, please contact Takeda UK Ltd on 01628-537900.
Date of preparation: March 2008