From:
Sukie Crandall
Date: 2010-07-29 19:48:51 UTC
Subject: [ferrethealth] FDA pet alert
To: fhl <ferrethealth@yahoogroups.com>, Ferret Mailing List <ferret-l@LISTSERV.FERRETMAILINGLIST.ORG>
<http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanM=
edicalProducts/ucm220548.htm
>
<http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm220217.htm>
Also see:
<http://news.vin.com/VINNews.aspx?articleId=3D15950>
about hormonal exposure of pets
This topic has come up before because in ferrets the symptoms can look=20
like heat, or like adrenal disease, or cause other problems and=20
symptoms related to hormonal levels that are too high, such as can=20
happen with adrenal disease or heat.
A veterinary piece leads me to believe that this could not be the only=20
product related to such problems so if other companies are as=20
responsible then more alerts will happen as more is known and reported:
> On this page
>
> =95 Advice for Consumers
> =95 If Contact Occurs
> The Food and Drug Administration (FDA) says children and pets should=20
> not be exposed to Evamist, a drug for women that is sprayed on the=20
> skin to treat hot flashes caused by menopause.
>
> The agency also wants consumers to take precautions to ensure that=20
> children and pets do not make contact with skin where Evamist has=20
> been sprayed.
>
> Evamist contains the estrogen hormone estradiol. It is sprayed=20
> inside the forearm between the elbow and wrist.
>
[a spot where ferrets often touch -- moderator]
...
> "Women using Evamist need to be aware of the potential risks to=20
> children who come in contact with the area of skin where this drug=20
> is applied," says Julie Beitz, M.D., a director of drug evaluation=20
> with FDA. "It is important that people know to keep both children=20
> and pets away from the product to minimize exposure."
>
>
>
...
> =95 not allow pets to lick or touch the arm where Evamist was=20
> sprayed. Small pets may be especially sensitive to the estrogen in=20
> Evamist. Contact a veterinarian if your pet shows signs of nipple=20
> and/or vulvar enlargement, or any other sign of illness
> =95 wear a garment that covers the arm where Evamist was sprayed if=20
> they know they cannot keep a child or pet from making contact with it
>
...
> If Contact Occurs
>
>
> =95 washing the child's [pet's] skin with soap and water as soon as=20
> possible
> =95 contacting the child's [pet's] health care professional=20
> if ...signs or symptoms
...
> You can report any side effects from the use of Evamist to FDA=92s=20
> MedWatch Adverse Event Reporting Program online or by mail, fax, or=20
> 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=20
> with other topical (applied to the skin) estrogen products.
>
> FDA continues to review adverse event reports and evaluate ways to=20
> reduce unintended exposures.
>
> This article appears on FDA's Consumer Updates page, which features=20
> the latest on all FDA-regulated products.
>
> Posted July 29, 2010
>
>
>
The press release:
> Evamist (estradiol transdermal spray): Drug Safety Communication -=20
> 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=20
> reviewing reports of adverse effects from Evamist, an estrogen=20
> hormone used to reduce hot flashes during menopause. Children=20
> unintentionally exposed to the drug through skin contact with women=20
> may experience premature puberty. Female children may experience=20
> nipple swelling and breast development. Male children may experience=20
> breast enlargement.
>
> BACKGROUND: Evamist is a topical product, sprayed on the skin on the=20
> inside of the forearm between the elbow and the wrist. FDA is=20
> currently reviewing reported adverse events and is working with the=20
> company to identify any factors that may contribute to unintended=20
> exposure. The Agency will update the public when this review is=20
> complete. FDA and the company are also evaluating ways to minimize=20
> the risk.
>
> RECOMMENDATION: Patients should make sure that children are not=20
> exposed to Evamist and that children do not come into contact with=20
> any skin area where the drug was applied. Women who cannot avoid=20
> contact with children should wear a garment with long sleeves to=20
> cover the application site. Additional information for Healthcare=20
> Professionals, Information for Patients, and a Data Summary are=20
> provided in the Drug Safety Communication at the link below.
>
> Healthcare professionals and patients are encouraged to report=20
> adverse events or side effects related to the use of these products=20
> to the FDA's MedWatch Safety Information and Adverse Event Reporting=20
> Program:
>
> =95 Online: www.fda.gov/MedWatch/report.htm
> =95 Phone: 1-800-332-1088
> =95 Mail: return the postage-paid FDA form 3500, which may be=20
> downloaded from the MedWatch "Download Forms" page, to address on=20
> the pre-addressed form
> =95 Fax: 1-800-FDA-0178
>
>
> [07/29/2010 - Drug Safety Communication - FDA]
> [07/29/2010 - Keep Kids, Pets Away From Skin Sprayed With Evamist -=20
> 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)
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