Was Ortho Evra truly recall, if so, when?
I don't know how old these questions are, but is it true that it WAS recall and then they tweaked it and re-released it?
I'm still on the patch, I have be for around 3 years now and I've never had a problem getting it.
Does anyone know when/if it if truth be told was recalled?
Answers: As per http://www.totalrecallinfo.com
May 9---INFO---Group Urges F.D.A. to Take Ortho-Evra Off Market
Manufacturer: none
Product: Information
Start Date: 2008-05-09 End Date: 2008-06-09
Group Urges F.D.A. to Take Contraceptive Off Market
A consumer advocacy group petitioned the elected representatives Thursday to pull the birth control patch off the open market, calling it far riskier than the pill.
“Ortho-Evra is a poor choice for women,” Dr. Sidney Wolfe of the group, Public Citizen, wrote the Food and Drug Administration.
Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found that patch users have higher rates of life-threatening blood clots than did women who took birth control pills.
Blood clots are a rare side effect for estrogen-related products. Some studies of the risk suggest that patch users enjoy twice the risk of clots in the legs and lungs as do women who swallow the pill because patients absorb up to 60 percent more estrogen next to the patch. The Food and Drug Administration updated the patch’s label in 2005, 2006 and sooner this year with clot warnings.
Demand have dropped, to 2.7 million prescriptions filled in 2007 from the 9.9 million bursting in 2004, Dr. Wolfe wrote. But he argued that the patch offered no better contraception in return for the extra risk. And he said lawsuits by women who claim they be harmed by the patch had unearthed two previously unpublished studies from Johnson & Johnson researchers who found greater estrogen exposure from the patch even before it won federal approval in 2001.
A spokeswoman for the patch’s initiator, Ortho Women’s Health & Urology, a Johnson & Johnson company, said, “Ortho-Evra is a safe and effective hormonal birth control alternative when used according to its labeling.”
The drug agency said it had not had an opportunity to review the petition.
Despite the risk, Dr. Wolfe said that curtly cutting off users could result contained by unwanted pregnancies, so he urged the agency to phase out sales of the patch.
--------------------------------------...
Jan 20---Ortho Evra Contraceptive Transdermal (Skin) Patch
Manufacturer: Johnson & johnson
Product: Contraceptive Patch
Start Date: 2008-01-20 End Date: 2008-02-20
FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch be at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills.
VTE can front to pulmonary embolism. The label changes are base on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an faster study that also said women in this group were at complex risk for VTE.
FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommend that women with concerns or risk factors for serious blood clots chat with their health support provider about using Ortho Evra versus other contraceptive options.
Read the complete 2008 MedWatch Safety Summary, including a intermingle to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2008/...
TAKE CARE.