FDA Letters to Send Dr. Sebelius

Too all:

       Attached are samples of two letters that would be helpful if you could fill in the blanks and send to Dr. Sebelius. The longer letter is for the patient to fillout and the other for a friend, relative etc. Send the letter return receipt requested. We really need to get her attention. I have sent my own letter which I will copy  you on tomorrow. Also, I working on a letter to the editor I will also copy you on. I am hopeing to get the media involved shortly.

     Finally, I started this blog “The Darvocet Cause” to enable an exchange of idea’s on how to get this drug on the market again, so input would be appreciated.

     Looking forward to hearing from you all,

                            Barbara

Dr. Kathleen Sebelius

Secretary of Health and Human Services

200 Independent Ave. S.W.

Washington, D.C 20201.

 

 

Dear Dr. Sebelius

My________(son, daughter, relative, friend) was using Darvocet/Propoxphene for _______.This was the only drug that allowed my _____ to have a fairly good quality of life.

Prior to the recall my______ could do________. Since the recall_____(he, she, my friend etc) can no longer do ______or does so in extreme pain. Also, the personalty changes have been significant because of having to live in chronic pain, so it affects everyone.

My_______has tried other pain medications, such as________. Either these don’t work or the side effects are too severe. I would implore you to assist in getting this drug back on the market.

Thank you,

OR

DATE

 

 

Address

 

 

Dear______

I am participating in a formal citizen’s petition and supplement filed with FDA in mid-January 2011 to revoke the recall of Darvocet/Propoxphene. After waiting for approximately 6 months the FDA didn’t issue a decision, but instead opted to continue its evaluation. Because there is still no decision (no other pain medications work or have too many side affects) my quality of life remains severe compromised.

I suffer from_________ which causes me severe pain and has affected my life in the following ways:______________. Prior to the recall I had been using Darvocet/ Propoxphene for ___)years ,with no adverse effects. Since its recall I have tried _______ which causes me________. So, I have no other alternatives and now my quality of life is severely affected. Shouldn’t it be my decision (after being informed of the side effects) whether the “benefits outweigh the risks” of using Darvocet.?

This drug has been on the market since 1957, if it causes heart problems that would have been apparent a long time ago. One study with questionable results doesn’t justify removing the one pain medication that affords me a decent quality of life. The drug was removal in the US and other countries because of misuse, either accidentally or intentionally, that does n’t justify the recall.

No doubt if there was reliable scientific data to support the removal, that it causes heart problems, I would be part of this recall. Please look into this matter and help get this drug back on the market. Everybody has the right to decide the risks they want to take and the quality of life they want to live.

Thank you,

 

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FDA Darvocet Update

To All:

I haven’t forgotten you, I have been focusing on the status of the Darvocet lawsuits mulitple plaintiff’s have filed claiming cardiotoxicity. I spoke to the individual overseeing the evalution of the petition to get the status. As most of you know we are coming up on the deadline for FDA to respond. I’ve been told we will receive some type of response within the deadline. This could be agreeing to revoke the recall, disagreeing or requesting additional time. Hardly helpful, but at least there is an indication we will hear any day. As soon as I know I will post the decision on this blog .

Keep in mind that I am hopeful but wouldn’t be surprised if it was denied. It was always my expectation that I would have to file suit in federal court. Filing the petition was required before I could bring a federal action. In the event an action is filed I believe there is a good possibilty of prevailing-no guarantees. have faith.

Finally, there are manufacturers willing to produce Darvocet, but are concerned about liability.

Barbara