Monday, December 12, 2011

FDA Panel Cites Clot Risk From Contraceptive Patch

FDA Panel Cites Clot Risk From Contraceptive Patch

MONDAY, Dec. 12 (HealthDay News) -- An advisory panel to a U.S. Food and Drug Administration on Friday pronounced that a Ortho Evra birth control patch carries a aloft risk of blood clots for women compared to older methods, though should not be taken off drug store shelves.

The panel, that formed a preference on a formula of a new examination of the data, voted 19 to 5 that a advantages of Johnson & Johnson's Ortho Evra patch surpass a risks, that enclosed a aloft risk for blood clots lodging in a legs or lungs.

The panelists felt that a patch, initial authorized in 2001, stays a valuable choice for those younger women who find it tough to hang to a daily fast of a 'Pill,' a Associated Press reported.

"I have many teenagers and it's a customarily process they'll use -- for them it's a ideal method," Dr. Melissa Gilliam of a University of Chicago, told a AP.

The row did opinion 20 to 3 (with one abstention) that a patch's labeling requires updating to improved surprise women of a aloft risk for clots.

Studies on risks compared with a patch have had opposing results. The many new investigate by a FDA found a 50 percent aloft risk for clots for women on a Ortho Evra patch contra those on several forms of a 'Pill.' But FDA scientists stressed that a information was not conclusive, a AP said.

The news group pronounced that prescriptions for Ortho Evra have waned over the past 5 years, from 5 million in 2006 to around 1.3 million in 2010.

Friday's proclamation followed on a heels of a preference by a same FDA-appointed row on Thursday that several newer forms of verbal contraceptives lift revised labels warning about an augmenting risk of potentially deadly blood clots.

The U.S. Food and Drug Administration advisers voted 21-5 in preference of the new labels for verbal contraceptives such as Bayer's Yaz or Yasmin. Both contain a newer form of synthetic progestin hormone called drospirenone, which could boost a chances of dangerous clots in a legs or lungs, compared to comparison forms of verbal contraceptives. The newer contraceptives have been successfully marketed on a grounds that they have fewer of a unwanted side effects of comparison hormone pills such as bloating, mood swings and acne.

Speaking forward of a decision, Dr. Tara Narula, a cardiologist during Lenox Hill Hospital in New York City, pronounced that a risk of clotting with the newer pills is "a low risk though a risk exists. The thought of a FDA looking during this and potentially augmenting a warning has no downside. If anything, it increases recognition and that can customarily be a good thing."

Earlier Thursday, a row members voted 15 to 11 that a newer contraceptives, that gained initial FDA capitulation in 2001, are a viable method of birth control, and that a advantages of preventing pregnancy outweigh a health risks.

While a FDA isn't thankful to follow a recommendations of a advisory panels, it customarily does so.

More information

The U.S. Department of Health and Human Services has some-more about birth control during .


News referensi http://news.yahoo.com/fda-panel-cites-clot-risk-contraceptive-patch-170210054.html

No comments:

Post a Comment