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Novartis removes 'share' button for Tasigna

Novartis has removed a 'Facebook share' widget from the Tasigna (nilotinib) website following a warning letter issued by the US FDA

Novartis has removed a 'Facebook share' widget from the website for its tyrosine kinase inhibitor Tasigna (nilotinib), after the company received a warning letter from the US Food and Drug Administration (FDA), which stated that the shared content was misleading and did not meet FDA requirements for disclosing drug information.

In 2007, Tasigna was approved for the treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukaemia (Ph+ CP-CML) in adult patients whose disease had progressed or who could not tolerate other therapies, including Gleevec/Glivec (imatinib).

In June 2010, the FDA approved Tasigna as a first-line treatment for Ph+ CP-CML. Its approved labelling warns that Tasigna may cause an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures or sudden death.

The letter stated that: "The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products. Thus, the shared content for Tasigna misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations."

It goes on to state that Novartis failed to submit the shared content for FDA review, though the Tasigna website itself had been submitted and approved.

"We have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA," Novartis wrote in a statement. "[The company] will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our web assets and materials based on these concerns."

The issue of how pharmaceutical companies can comply with FDA marketing guidelines – adequately to express complete indications and risk information – in the little space permitted by social media widgets has not yet been solved, and the area is not yet regulated.

The warning letter (pdf) was sent by the Agency's Division of Drug Marketing, Advertising and Communications (DDMAC) section on July 29 and published on the FDA website last week. This letter represents the fourth communication Novartis has received from DDMAC so far this year.

9th August 2010

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