Re: [MOL] Hydrazine Sulfate [01785] Medicine On Line


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Re: [MOL] Hydrazine Sulfate



Dear Bill,

Thank you for this message.

God Bless
marty auslander

Bill Comcowich wrote:
> 
> I thought that MOLers would like to see the following article on Hydrazine Sulfate. It comes from Health News Daily, a newsletter. Bill
> 
> Pharmacy Compounding Advisory Committee defers vote on hydrazine sulfate inclusion on bulk drugs list until more information is obtained; FDA calls widely used substance "toxic".
> 
> Health News Daily: HYDRAZINE SULFATE INCLUSION ON LIST OF BULK DRUG SUBSTANCES SHOULD AWAIT FURTHER DATA before it can be added to the list of substances that can be compounded, members of the Pharmacy Compounding Advisory Committee suggested at its inaugural meeting Oct. 14. Committee chair Randy Juhl, PhD, University of Pittsburgh, indicated that the discussion on hydrazine would be deferred until another meeting but added: "What we will get will not be much more than what we have got."
> 
> On Oct. 15, the committee decided by a 6-5 vote to defer the decision on hydrazine until an expanded session is held in February, rather than deciding not to list the substance. Committee members supporting deferral included industry representative David Liebman, Kaye's Pharmacy (Baltimore), who noted that a decision not to list hydrazine would change the end-of-life treatment options for a large number of cancer patients, and should be carefully considered.
> 
> Hydrazine sulfate is used to treat cachexia in cancer patients. The compounded preparation is used in 5,000-10,000 patients annually, the International Academy of Compounding Pharmacists estimated. A number of committee members agreed with member Christopher Rhodes, PhD, University of Rhode Island, who argued that hydrazine should not be included on a list of bulk drug substances that pharmacists could use to compound drugs which are not components of FDA-approved drugs or listed in U.S. Pharmacopoeia or National Formulary monographs. "We know the drug substance is toxic; for this drug I would have great reservations for the committee to approve it," Rhodes said.
> 
> Rhodes highlighted two placebo-controlled clinical trials published in the Journal of Clinical Oncology, one showing no efficacy advantage for patients treated with hydrazine and the other showing decreased survival for treated patients versus those on placebo. However, the validity of the studies has been questioned, and Rhodes stated that "perhaps those criticisms are valid. " However, he noted that "if we do not approve the drug at this particular meeting, that does not mean that the drug" will never be placed on the list.
> 
> FDA "questions whether [hydrazine sulfate] is appropriate for inclusion on the bulk drugs list" because the substance "is extremely toxic," according to a preliminary draft proposed rule scheduled to be published in the Oct. 16 Federal Register. The compound has caused "liver and kidney damage, gastrointestinal damage, convulsions and coma," the agency says.
> 
> The proposed rule addresses the 38 substances that were nominated by the public for inclusion on the bulk drugs list, in accordance with an April 7 Federal Register notice. Nine of the nominations (clotrimazole, fluocinonide, hydrocortisone, hydroquinone, pramoxine, quinacrine hydrochloride, salicylic acid, tretinoin, and triamcinolone) are components of approved drug products or have USP monographs and already are permitted to be used in compounding. The remaining 29 were evaluated by the agency after researching literature references for each substance.
> 
> William J. Comcowich, President, UltiTech, Inc. / Medicine OnLine
> http://www.meds.com http://www.cyberalert.com
> Foot of Broad Street, Stratford, CT. 06497 203-375-7300
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