barbara.g
07.04.05, 13:01
W skrotowym tlumaczeniu: stanowczo zaprzeczaja doniesieniom o stwoerdzonej
szkodliwosci Elidelu, wyrazajac ubolewanie nad nieslusznym uznaniem tego leku
za rakotworczy w USA. Zapewniaja o prowadzeniu dalszych badan nad
dlugoterminowym wplywem stosowania specyfiku.
21-Mar-2005
Question: Elidel has been in the news quite a bit lately with regard to a
recommendation by the Pediatric Advisory Committee to add a ‘black box’
warning to the label. The FDA then followed with a Talk Paper and Public
Health Advisory. Do you agree with the FDA’s announcement, and what action is
Novartis taking in response to the FDA Talk Paper and Public Health
Advisory? — Name withheld
Answer: I am extremely disappointed with the recommendation of the FDA
Pediatric Advisory Committee. There is absolutely no scientific evidence to
support their recommendation for a label change. None. In fact, the FDA
itself acknowledges that no causual link between Elidel and cancer has been
established. We need to make sure physicians and patients have the
information they need to safely and effectively treat eczema—the recent
announcements regarding Elidel are misleading, and may steer patients towards
steroid treatments, which have a host of potentially serious side effects.
I’m especially disappointed because the safety of the people who use any of
our products is always our highest priority. Clinical studies involving more
than 19,000 patients worldwide--including more than 2,600 infants and 7,300
children--demonstrated Elidel to be effective with a favorable safety
profile. It has been used by over 5 million patients worldwide and no safety
signal has been observed. In addition, we are also committed to providing
assurances regarding the long-term safety of Elidel, and have initiated two
long-term clinical studies and an observational registry with thousands of
pediatric patients for 10 years.
Elidel is a safe and effective alternative to steroid-based treatments, and
this conclusion is supported by many of the world’s leading clinical experts.
For example, the American Academy of Dermatology states: “There is no data
that proves proper topical use of pimecrolimus and tacrolimus is dangerous in
people… These are valuable medications, and if used properly, they
significantly reduce the debilitating impact of eczema and allow millions of
our patients to live normal lives.”
We will continue to work with the FDA and to discuss an appropriate label for
Elidel. We will be sure to keep you informed. — Thomas Ebeling