Table 1. Serious (§2) off-label promotion violation rulings, 2003–2012.
| Case no. | Case summary | Drug class/ATC |
|---|---|---|
| 1544/1/04 | Napp marketed OxyContin (prolonged release oxycodone) in detail aid and leave piece 1 with claims of “Straightforward dosing” and “5 mg starting dose in frail patients or those with renal or hepatic impairment.” However, the drug was contraindicated in patients with moderate to severe hepatic impairment or severe renal impairment. According to the ruling, claims gave the impression that patients with any degree of renal or hepatic impairment could have treatment initiated at 5 mg. This could lead to OxyContin use in patients for whom it was contraindicated and might therefore compromise patient safety. | Analgesics (N02) |
| 1557/2/04 | At a scientific meeting, Aventis promoted an off-label use of Taxotere (docetaxel) by soliciting requests from health professionals for a publication that discussed unlicensed use of Taxotere in combination with carboplatin. Dissemination of the publication had previously been found to breach the Code. Aventis was therefore in breach of an undertaking. | Antineoplastic agents (L01) |
| 1708/5/05 | After reports of adverse effects in ongoing clinical trials for a competitor’s MS (multiple sclerosis) drug, Serono sent company-produced clinical guidelines with a cover letter signed by Serono’s medical director for northern Europe to trial investigators encouraging them to switch patients over to Serono’s drug Rebif (interferon beta-1a). Provided information implied that Rebif could be used to treat all MS patients, but Rebif was indicated for the treatment of MS with two or more relapses within the last 2 y. This was considered a particularly serious matter “where it appeared aggressive marketing had been undertaken with disregard of the Code.” | Immuno-stimulants (L03) |
| 2008/6/07 | ProStrakan reused an advertisement with a claim that Rectogesic (glyceryl trinitrate) could heal chronic anal fissures when it was only licensed for relief of pain associated with chronic anal fissures. The claim had previously been ruled in breach and ProStrakan was thus in breach of an undertaking. | Vasoprotectives (C05) |
| 2125/5/08 | Advertisement by Takeda in Diabetologia claimed that “there are no long-term cardiovascular concerns regarding the use of Actos (pioglitazone).” However, there was no mention that Actos was contraindicated in patients with cardiac failure or a history of cardiac failure or might cause fluid retention, which might exacerbate or precipitate heart failure. The MHRA had found Takeda to have breached advertising regulations for a similar advertisement before, and had also asked Takeda to issue a corrective statement. The PMCPA expressed its concern for patient safety. | Diabetes drugs (A10) |
| 2330/7/10 | In a poster session at the British Pain Society meeting, Grünenthal promoted Versatis (lidocaine) with the following claim: “Conclusion, Versatis has an ‘off-label’ use for the symptomatic relief of localised neuropathic pain, and could provide a substantial saving to the local health-economy.” | Anaesthetics (N01) |
| 2383/2/11 | Bayer promoted Yasmin (ethinylestradiol and drospirenone) with the following claim: “Yasmin. It’s for more women than you might imagine.” The product logo to the right of the claim at issue included the strapline “Contraception and more.” A bullet point stated that Yasmin had been shown to have a beneficial effect versus baseline on acne, fluid retention, hirsutism, and premenstrual symptoms. These were not licensed indications but instead included possible adverse reactions listed in the SPC. | Sex hormones and modulators of the genital system (G03) |
| 2404/5/11 | Boehringer Ingelheim issued a press release on Pradaxa (dabigatran) that formed the basis for articles in the consumer press referring to Pradaxa use for stroke prevention, an unlicensed indication. Boehringer Ingelheim had promoted a prescription-only medicine to the public in an indication that was not yet licensed, the PMCPA concluded. | Antithrombotic agents (B01) |
| 2435/8/11 | Chiesi invited UK health professionals to a symposium at which Fostair (beclometasone and formoterol) was promoted for chronic obstructive pulmonary disease (COPD) when only licensed in the UK for the regular treatment of asthma. Chiesi had previously been ruled in breach for Fostair promotion off-label at a meeting of the British Thoracic Society. Chiesi had thus failed to comply with a previous undertaking. | Drugs for obstructive airway diseases (R03) |
| 2506/5/12 and 2507/5/12 | Lilly and Daiichi-Sankyo marketed Efient (prasugrel) with a leave piece 1 that promoted use beyond the maximum licensed duration of treatment. The SPC stated, “Treatment of up to 12 mo is recommended, unless the discontinuation of Efient is clinically indicated …”, but the leave piece promoted off-label use for 15 mo. The leave piece also included various misleading statements and misrepresentation of safety data. A breach of §2 was ruled in relation to the leave piece as a whole. | Antithrombotic agents (B01) |
1 Leave piece refers to print marketing material that is left behind during a sales visit.