[e-med] Contrefaçons de patchs contraceptifs aux Etats-Unis

[remed@remed.org]

E-MED: Contrefaçons de patchs contraceptifs aux Etats-Unis
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La FDA (US Food drug and administration) signale sur son site des
contrefaçons de patchs contraceptifs. C'est assez rare qu'on signale des
contrefaçons dans les pays développés...
Pour ceux qui sont intéressés voici l'article en anglais et vous pouvez
aussi consulter les photos...
Carinne Bruneton
ReMeD

***************

FDA News
FOR IMMEDIATE RELEASE
P04-13
 February 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive
Patches Sold Through Foreign Internet Site
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html
FDA and Johnson & Johnson of Raritan, NJ ar warning the public about an
overseas internet site selling counterfeit contraceptive patches that
contain no active ingredients. These counterfeit patches provide no
protection against pregnancy.

This internet site's domain name, www.rxpharmacy.ws apparently is operated
by American Style Products of New Delhi, India. The site also sells other
products that purport to be versions of FDA-approved drugs. FDA is
investigating these other products as well, and urges consumers to treat any
drugs purchased from this firm as being suspect. None of these products
should be considered safe or effective. Consumers who have any of these
products should not use them, but instead contact their healthcare providers
immediately.

"FDA will continue to do all it can to protect Americans from unsafe and
counterfeit drugs purchased from illegal foreign sites," said FDA
Commissioner Mark B. McClellan, M.D., Ph.D. "This case highlights the
serious risks posed by foreign drug operations that bypass FDA safeguards.
People are risking their health, in some cases their very lives, by buying
illegal internet drugs."

To protect the public health FDA has obtained the cooperation of the
U.S.-based internet service provider in shutting down service to this site.

The counterfeit contraceptive patches were promoted as Ortho Evra
transdermal patches, which are FDA approved, and made by Johnson & Johnson's
Ortho-McNeil Pharmaceutical, Inc. subsidiary.

Instead customers receive packages of patches without the active ingredient
necessary to make the patches effective. Moreover, the counterfeits are sent
in simple plastic zip-lock bags without identifying materials, lot numbers,
expiration dating or any other labeling information needed to safely and
effectively use this prescription product.

The FDA-approved Ortho Evra contraceptive patch is an adhesive patch that
contains a combination of an estrogen and a progestin for contraception. The
patch is applied to the skin of a woman's abdomen, upper outer arm, upper
torso or buttock for seven days. A new patch is applied each week for three
weeks (21 total days), followed by one patch-free week.

The FDA-approved patch product is 1¾ inches square, beige in color, made of
a thin film, and comes packaged in a sealed, opaque, white pouch with the
product label attached to one side of the pouch. The lot number and
expiration date for the product are printed on the attached label and on the
back side of the pouch without the attached label.

The counterfeit product is 1½ inches square, brown in color, made of woven
material, and has 5 holes that appear as red dots on the middle of the top
side of the patch. This product also has a ¾ inch orange square resembling
gauze under the plastic liner on the back side of the patch. The product
does not come packaged in a sealed pouch and does not contain lot number or
expiration date information.

Photos contrasting the legitimate contraceptive patch with the counterfeit
are on display at the FDA's website:
http://www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html

Women who have been sent contraceptive patches lacking proper labeling or
not having the appearance of the approved Johnson & Johnson Ortho Evra
product as described above should not use the product and should contact
their healthcare providers immediately.

FDA's Office of Criminal Investigation is working with Johnson & Johnson and
the Department of Homeland Security's Bureau of Immigration and Custom
Enforcement's (ICE) Cyber Crimes Center to combat counterfeiting and other
illegal internet drug sales and take effective action against those
responsible. Trafficking in counterfeit, unapproved adulterated, or
misbranded products is a felony violation of the Federal Food Drug, and
Cosmetic Act. FDA is particularly grateful for the expeditious assistance in
this matter provided by the ICE Cyber Crimes Center. The criminal
investigation is ongoing.

To date no reports of pregnancies linked to this product have been received
by FDA and distribution of the counterfeit products appears limited to this
internet site.

Consumers seeking to buy safe and effective drugs via the internet should
only purchase from internet sites bearing the Verified Internet Pharmacy
Practice Sites (VIPPS) seal showing that they  are in accordance with the
National Boards of Pharmacy standards.

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