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Author Topic: FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist  (Read 3649 times)
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3catkidneyfailure
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« on: July 30, 2010, 05:53:36 AM »

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220540.htm

FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist
FDA NEWS RELEASE
For Immediate Release: July 29, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist

The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product. ...

Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child’s skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product.  If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.

At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.

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Spartycats
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« Reply #1 on: July 30, 2010, 06:00:08 AM »

A related article

http://news.vin.com/VINNews.aspx?articleId=15950
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JJ
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« Reply #2 on: August 10, 2010, 07:54:16 PM »

OMG just now reading this. If this spray and also the cream which came first has this kind of effect on pets and children - what does it do to the person using it? Thanks so much 3cats for posting this as this is the first I have heard of it.

To stop hot flashes (at least give it a try for a couple of weeks to see if it works for you) stop using, eating all forms of sugar whether in baking, cooking, or eating. (this includes bread, crackers etc. as the carbs turn into sugar) Years back a female doc was on a show and said stopping sugar and hot flashes will vanish. (btw I tried it and it works so might for you too)

This stuff is dangerous. I would not want any of it on me, near me or around my pet, let alone children.
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caylee
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« Reply #3 on: August 10, 2010, 08:00:46 PM »

Small ice packs - the kind used to keep your work lunch cold - can also work wonders for those hot flashes. And best of all, no side effects!

ETA - OT but . . 

caylee
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« Last Edit: August 10, 2010, 08:13:46 PM by caylee » Logged
JJ
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« Reply #4 on: August 10, 2010, 08:05:24 PM »

caylee ice plus combo of no sugar - you get cool both ways and added benefit of no sugar - less calories and still no side effects (er maybe wt loss as a benefit side effect  Wink  )
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Fizzy1
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« Reply #5 on: August 10, 2010, 08:55:47 PM »


ETA - OT but . . 

caylee
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Whoo EEEE!  You go Girl Grin 
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menusux
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« Reply #6 on: October 12, 2010, 04:03:02 PM »

http://news.vin.com/VINNews.aspx?articleId=16733

VIN News October 11, 2010

Accidental hormone exposures prompt proposed drug label changes

"Ther-Rx Corp., marketer of the spray-on female hormone therapy product Evamist, has proposed changes to the product label aimed at preventing accidental exposures of people or pets coming in contact with the drug’s users, according to a company official.

"Jennifer Gudeman, a pharmacist and director of medical communications for KV Pharmaceutical, parent company of Ther-Rx, said the company notified the U.S. Food and Drug Administration (FDA) in September 2009 of reports it had received of children and animals being inadvertently exposed to the topical hormone treatment. At that time, the company proposed modifications to the drug label to address such exposures, Gudeman said.

"Gudeman said the FDA is reviewing the proposed changes. In July — 10 months after the company alerted it to secondary-exposure incidents — the agency issued a safety announcement that it was reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed through skin contact with women using the product.

"The agency also received reports of inadvertent exposure in three spayed dogs: a 13-year-old Yorkshire terrier; a dog of unknown age or breed; and a 9-year-old dog of unknown breed. (The FDA’s July 29 safety announcement referred to two canine cases but on Aug. 6, in response to a Freedom of Information Act request from the VIN News Service, the agency provided information on three cases.)

"Symptoms in the Yorkshire terrier were a swollen vulva, swollen nipples and liver failure. The second dog experienced vaginal prolapse and elevated estrogen levels. The 9-year-old dog presented with an enlarged vulva and enlarged uterine stump.

"A fourth case of suspected Evamist exposure in a dog was reported to the VIN News Service in September by the pet’s owners, Daniel and Denise Haney of Las Vegas, after they read a VIN News report on secondary hormone exposures in household pets."

The Haney's story continues at the link.  Ther-Rx invited the couple to submit copies of the veterinary bills for treatment of Dory's exposure to their product.  Despite the fact that noted veterinary specialists made the connection between Dory's illnesses and her exposure to Evamist, the pharmaceutical company refused to reimburse the Haneys for Dory's medical care.  Angry
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3catkidneyfailure
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« Reply #7 on: October 12, 2010, 04:48:11 PM »

I'm sure the cost of veterinary care would probably exceed the cost of pet property replacement in the pharmaceutical company's
view. Until the legal status of pets as replaceable property gets changed, this keeps happening to pet owners and pets. The AVMA is the only medical profession sworn to promote animal health and welfare by oath and keeping pet replacement costs low that I can think of. What if the AMA adopted this approach to human medical treatment and welfare. The dichotomy just burns me up and is the reason
pet food companies and drug companies and even vets have no reason to fear pet owner lawsuits.
« Last Edit: October 12, 2010, 04:50:14 PM by 3catkidneyfailure » Logged
JJ
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« Reply #8 on: October 12, 2010, 10:03:22 PM »

Holy cripes! Since this Evamist can do this to pets and children - exactly what does it do to the woman using it? Scary stuff - thanks for the info menusux.
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