E-DRUG: information on Lodema brand of Coumarin

[Joel Lexchin <joel.lexchin@utoronto.ca>]

E-drug: information on Lodema brand of Coumarin
-----------------------------------------------

Dear E Druggers:

I received this notice and I am posting it here in the hopes that someone,
especially in Australia might be able to provide some further information.
If anyone can help they can either get in touch with me or contact Cathy
McPherson directly at her e mail address: nermo@interlog.com

Thanks,

Joel
--------------------


>Joel - I would appreciate any information members of your e-list have about
>Lodema brand of Coumarin (5,6-benzo-[alpha]-pyrone) and other types of
>coumarin, benzopyrones (ie effectiveness of creams, etc.).
>
>My problem is this:
>
>In August, 1996 The Secretary of the Department of Health and Family Services
>cancelled the registration in Australia of Lodema brand of coumarin tablets
>200 mg. Lodema brand of coumarin tablets 200 mg were marketed in Australia
>>before the current Therapeutic Goods Act took effect in 1991. For this
>reason, >they were automatically registered ("grandfathered") on to the
>Australian
>Register of Therapeutic Goods. The sponsor of the product was The
>Lymphoedema >Association of Australia Inc.
>
>In May 1996, the sponsor was given notice of the intention to cancel the
>registration and also given an opportunity to make submissions. The notice
>of the intention to cancel the registration was given following advice from
>the Australian Drug Evaluation Committee.
>
>The Committee had recommended cancellation of registration following the
>receipt of two reports of deaths of Australian women who developed
>hepatotoxicity associated with the use of Lodema.
>
>Other drugs had also been taken. There had also been a number of other
>Australian reports of patients who developed abnormalities of liver function
>test results or more serious signs of hepatoxicity associated with the use
>of Lodema. In addition, the Committee had some concerns about the adequacy
>of available information about the pharmaceutical aspects of Lodema 200mg
>>tablets.
>
>After the decision the Lymphedoema Association of Australia posted a list of
>places people could get the drug through mail order.
>
>I have posted the decision of the Committee on the Lymphovenous Canada web
>site to ensure that people with lymphedema can get unbiased information on
>this drug. (see Lymphovenous Canada: Health Watch -
>http://www.interlog.com/~mcpherc/watch.htm)
>
>Canada does not permit the drug to be sold here - I have heard that France
>and Germany have cancelled there approval of the drug in their countries
>because of deaths/liver damager that have happened there but I have not been
>able to confirm this information despite making a number of long-distance
>calls, sending e-mails, etc.
>
>Then - to add to the challenge/mystery I was contacted by a law student from
>an Adelaide Australian law firm representing the family of an elderly woman
>whose death was the subject of a coroner's inquest.
>
>The woman was prescribed Lodema in response to the development of
>Lymphoedema arising from a radical mastectomy. The cause of death was
>given as spontaneous bacterial peritonitis and ascites due to acute
>liver failure, mentioning a past history or carcinoma of the breast.
>
>Once again I attempted to find out about the inquest and heard that the
>inquest was taking place in early 1998 but I never found out who it was,
>what the outcome was, etc.
>
>I would appreciate any information your e-mail chums might have on this and
>also any additional research/information on this drug.  I am not a scientist
>or doctor so it would be helpful if they provided a plain language
>explanation as well as the scientific one and references, etc.
>
>Also if people have heard of deaths or liver damage/abnormalities as a
>result of this drug I would appreciate learning about it.
>
>Thanks so much for your help with this.
>--
>Cathy McPherson, 8 Silver Ave., Toronto, Ontario M6R 1X8, Canada
>E-mail: nermo@interlog.com
----------------------------------

Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone:  (416)-964-7186
Fax:  (416)-923-9515
e mail:  joel.lexchin@utoronto.ca

 
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