Healthy Skepticism Library item: 13640
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Silverman E.
Both Sides Now? Novartis Magnet Gets FDA Warning
Pharmalot 2008 May 12
http://www.pharmalot.com/2008/05/both-sides-now-novartis-magnet-gets-fda-warning/
Notes:
FDA warning letter:
http://www.fda.gov/cder/warn/2008/Trileptal-WL.pdf
Promotional material:
http://www.fda.gov/cder/warn/2008/Trileptal-Promo.pdf
Full text:
This was either clever or not too bright. A magnet distributed by Novartis for the past couple of years to promote its Tripleptal drug for epilepsy placed all of the safety and risk info on the back. As a practical matter, this meant the safety and risk info was obscured. (Take a look – http://www.fda.gov/cder/warn/2008/Trileptal-Promo.pdf). Think about it – when you place a magnet on the refrigerator, how often do you look at the other side?
If you answered once in awhile, you must move your magnets around a lot, because the FDA believes most people simply don’t see the back side of a magnet and sent Novartis a warning letter. The magnet “because it omits the full indication for Trileptal and omits information about the risks associated with its use,” the FDA wrote.
Of course, the FDA wants Novartis to stop distributing the magnets. Meanwhile, Ludwig Hantson, who heads Novartis’ Pharma operations in North America, can replace his own magnet on his refrigerator with the FDA letter, as a reminder.
Speaking of reminders. Shire Pharmaceuticals was also sent a warning letter by the FDA for distributing a notebook and medical exam light case (look here – http://www.fda.gov/cder/warn/2008/Fosrenol-Promo.pdf) that make representations or suggestions about its Fosrenol med for end-stage renal disease. These failed to pass the smell test for reminder labeling, which is labeling that calls attention to the name of the drug, but doesn’t include indication, dosage recommendations, or other info relating to the drug.
