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Subject:
From:
Sukie Crandall <[log in to unmask]>
Date:
Thu, 29 Jul 2010 15:48:51 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (142 lines)
<http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220548.htm>

<http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm220217.htm>

Also see:
<http://news.vin.com/VINNews.aspx?articleId=15950>
about hormonal exposure of pets

This topic has come up before because in ferrets the symptoms can
look like heat, or like adrenal disease, or cause other problems and
symptoms related to hormonal levels that are too high, such as can
happen with adrenal disease or heat.

A veterinary piece leads me to believe that this could not be the
only product related to such problems so if other companies are as
responsible then more alerts will happen as more is known and reported:

> On this page
>
> - Advice for Consumers
> - If Contact Occurs
>The Food and Drug Administration (FDA) says children and pets should
>not be exposed to Evamist, a drug for women that is sprayed on the
>skin to treat hot flashes caused by menopause.
>
>The agency also wants consumers to take precautions to ensure that
>children and pets do not make contact with skin where Evamist has
>been sprayed.
>
>Evamist contains the estrogen hormone estradiol. It is sprayed inside
>the forearm between the elbow and wrist.

[a spot where ferrets often touch -- moderator(SDC)]

 ...
>"Women using Evamist need to be aware of the potential risks to
>children who come in contact with the area of skin where this drug is
>applied," says Julie Beitz, M.D., a director of drug evaluation with
>FDA. "It is important that people know to keep both children and pets
>away from the product to minimize exposure."
 ...
> - not allow pets to lick or touch the arm where Evamist was sprayed.
>Small pets may be especially sensitive to the estrogen in Evamist.
>Contact a veterinarian if your pet shows signs of nipple and/or
>vulvar enlargement, or any other sign of illness
> - wear a garment that covers the arm where Evamist was sprayed if
>they know they cannot keep a child or pet from making contact with it
 ...

> If Contact Occurs
>
>- washing the child's [pet's] skin with soap and water as soon as
>possible
>- contacting the child's [pet's] health care professional if ...signs
>or symptoms
 ...
>You can report any side effects from the use of Evamist to FDA's
>MedWatch Adverse Event Reporting Program online or by mail, fax, or
>phone.
> o Regular Mail: Use postage-paid, pre-addressed FDA form 3500
> o Fax: 1-800-FDA-0178
> o Phone: 1-800-332-1088
>
>At this time, it is unknown whether unintended exposure can occur with
>other topical (applied to the skin) estrogen products.
>
>FDA continues to review adverse event reports and evaluate ways to
>reduce unintended exposures.
>
>This article appears on FDA's Consumer Updates page, which features
>the latest on all FDA-regulated products.
>
>Posted July 29, 2010


The press release:

>Evamist (estradiol transdermal spray): Drug Safety Communication -
>Unintended Exposure of Children and Pets to Topical Estrogen
>[Posted 07/29/2010]
> AUDIENCE: OB/GYN, Patient
>
>ISSUE: FDA notified healthcare professionals and patients that it is
>reviewing reports of adverse effects from Evamist, an estrogen hormone
>used to reduce hot flashes during menopause. Children unintentionally
>exposed to the drug through skin contact with women may experience
>premature puberty. Female children may experience nipple swelling and
>breast development. Male children may experience breast enlargement.
>
>BACKGROUND: Evamist is a topical product, sprayed on the skin on
>the inside of the forearm between the elbow and the wrist. FDA is
>currently reviewing reported adverse events and is working with the
>company to identify any factors that may contribute to unintended
>exposure. The Agency will update the public when this review is
>complete. FDA and the company are also evaluating ways to minimize
>the risk.
> RECOMMENDATION: Patients should make sure that children are not
>exposed to Evamist and that children do not come into contact with any
>skin area where the drug was applied. Women who cannot avoid contact
>with children should wear a garment with long sleeves to cover the
>application site. Additional information for Healthcare Professionals,
>Information for Patients, and a Data Summary are provided in the Drug
>Safety Communication at the link below.
>
>Healthcare professionals and patients are encouraged to report adverse
>events or side effects related to the use of these products to the
>FDA's MedWatch Safety Information and Adverse Event Reporting Program:
>
> - Online: www.fda.gov/MedWatch/report.htm
> - Phone: 1-800-332-1088
> - Mail: return the postage-paid FDA form 3500, which may be
>   downloaded from the MedWatch "Download Forms" page, to address
> on the
>        pre-addressed form
> - Fax: 1-800-FDA-0178
>
>
> [07/29/2010 - Drug Safety Communication - FDA]
> [07/29/2010 - Keep Kids, Pets Away From Skin Sprayed With Evamist -
>               FDA Consumer Updates]
> [07/29/2010 - News Release - FDA]
> [07/2009 - Evamist Prescribing Information - Ther-Rx Corporation]

Sukie (not a vet)

Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/
http://www.ferrethealth.msu.edu/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html
all ferret topics:
http://listserv.ferretmailinglist.org/archives/ferret-search.html
"All hail the procrastinators for they shall rule the world tomorrow."
(2010, Steve Crandall)

[Posted in FML 6774]


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