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Zelnorm Petition Update:
4/22/2008
Official Release from Novartis today re Zelnorm:
Zelnorm/Zelmac (USD 2 million, -98% lc), for irritable bowel syndrome
and chronic constipation, will not be resubmitted for US regulatory
approval. This medicine was suspended in the US in March 2007, and
subsequently in many other countries, to comply with a request from the
FDA to review cardiovascular safety data. However, Zelnorm/Zelmac
remains available in some countries, and Novartis will discuss next
steps with local health authorities, as requested. An emergency
treatment access program remains open in the US to provide Zelnorm to
appropriate patients.
4/16/2008
I have been contacted by a
number of patients who have been negatively impacted by the removal of
Zelnorm from the market last year. Zelnorm was taken off the market due
to unsubstantiated studies that it created cardiac problems in a small
handful of patients. Although over 900,000 people were benefiting
dramatically from the use of this drug, the FDA pulled it from the
market last year based on only a few cases in which patients experienced
cardiac complications while taking Zelnorm. The connection between
Zelnorm and the cardiac problems are questionable and not thoroughly
researched.
After the removal of Zelnorm, patients who had benefited experienced a
dramatic change in their conditions. They were forced to seek other
alternatives, and in the case of gastric motility disorders, those
alternatives are extremely limited or non-existent. This is not the
first time the FDA has removed a safe medication for the treatment of
gastric motility disorders from the market. Domperidone was never even
approved for use in the US, even though the associated risk factors were
far less than some of the more commonly used drugs such as Reglan,
Compazine, and Phenergan! Currently, there are NO drugs available in the
US to treat the underlying cause of Gastroparesis and associated
motility disorders, with the exception of Reglan, which causes
neuropathy symptoms in most patients. There are only anti-emetics to
treat the symptoms which are usually not very effective.
The FDA has a history of shying away from medication to treat gastric
motility disorders due to the history of Propulsid/Cisapride in the
1990's. The government and FDA do not recognize that Gastroparesis is a
severely disabling condition, and affects a large portion of the
population. The need for awareness of our plight is great, and by
speaking up and fighting for our cause, we will be able to make an
impact. This could lead to future treatment options being more carefully
considered, and not denied so quickly.
Everyone who has been impacted by the removal of Zelnorm from the market
last year, please contact your local senators and representatives and
fight to get back on it through an IND program, or to campaign for its
return. You can find the contact information for your local government
officials at
http://www.usa.gov/Contact.shtml.
In addition, call the FDA hotline at
1-888-463-6332 (INFOFDA) or the drug info line
between 8-4:30 PM EST at
301-796-3400 to share your story. There may be ways
that you can receive Zelnorm again if you fight for it.
More information about this can be obtained at
http://www.fda.gov/cder/drug/infopage/zelnorm/default.htm,
www.zelnorm.com, and more specific questions are addressed at
http://www.fda.gov/cder/drug/infopage/zelnorm/QA_2008.htm.
Please do not hesitate to contact me at
hastonc@g-pact.org, or through
Facebook, if I can be of any assistance. I would like to make this
process as easy as possible for everyone who participates in order to
ensure maximum participation and impact.
4/08/2008
In the short amount of time since
I posted the latest news information on Zelnorm, I have received a
number of e-mails from people expressing their experiences with
deterioration in their GP symptoms after Zelnorm was discontinued. This
has solidified my belief that the need for the return of this medication
is great.
G-PACT would like to encourage everyone who has been affected by the
withdrawal of Zelnorm from the market to please participate in a
campaign to bring it back. One of the reasons Novartis stated that they
did not fight harder to keep Zelnorm on the market, or at least
available on a tIND basis, is because they did not receive much feedback
from patients who had been taking it and fighting to keep it available
in the US.
If you have been adversely affected by the decision by Novartis and the
FDA to remove access to the drug except under emergency situations,
please share your story with them by going to
http://www.pharma.us.novartis.com/util/contact/email.jsp.
It is possible that with enough participation, we can influence their
decision and bring Zelnorm back to patients who were benefiting from it
with no adverse effects.
Please also feel free to contact me at
hastonc@g-pact.org if you would
like to share your experiences with me, have questions, or would like to
help in any way with the organization of this campaign. This is not the
first time patients with GP have been denied access to a safe and
effective medication, as Domperidone (Motilium) was never approved for
use in the US either.
Together, we can make a difference! Let's fight to let the FDA and
pharmaceutical companies aware of our need for effective medication and
impact the process of GP medication approval in the future!
4/08/2008
G-PACT received a call this
morning from Novartis that the eIND (emergency) access to Zelnorm
continues, but the tIND (temporary) program is history. This still
greatly limits the number of people who have access to this drug.
Originally, 900,000 people were benefiting from it. When it was pulled
from the market, tIND patients dropped to 90 and now there are currently
only 42 on emergency access.
I have received e-mails from people who had greatly benefited from
Zelnorm, and experienced great deterioration when it was pulled from the
market. They were then forced to seek other alternatives, which are not
as effective or generally, not as safe.
We experienced this with Domperidone as well. Two of the best and safest
drugs for motility disorders are not approved in the US and patients are
forced to stop taking them or to buy them from other countries. In that
instance, these drugs are not covered by insurance and patients are
forced to pay for them out of pocket. Some patients have even had their
medication seized at the border because they are not considered legal!
Please consider helping G-PACT in our fight to get Zelnorm returned to
the US, and have an impact on the availability and approval of future
drugs for gastroparesis!
Please contact me at
hastonc@g-pact.org. Also, please note if we are
allowed to share your story with representatives from the FDA and
Novartis who are involved in this process. For more info go to
www.zelnorm.com.
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