FDA Warning issued on birth control patch

[zendari]

Text

The Food and Drug Administration warned users of the popular Ortho Evra birth control patch that they are being exposed to more hormones, and are therefore at higher risk of blood clots and other serious side effects, than previously disclosed.

Until now, regulators and patch-maker Ortho McNeil, a Johnson and Johnson subsidiary, had maintained the patch was expected to be associated with similar risks as the pill. But a strongly worded warning was added to the patch label Thursday that says women using the patch will be exposed to about 60 percent more estrogen than those using typical birth control pills.
lthough most pills and the patch are loaded with the same amount of estrogen, hormones from patches go directly into the bloodstream while pills are swallowed and digested first. The result is that women using the patch have much higher levels of estrogen in their bodies.

Thursday's warning comes four months after The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill.

More than 4 million women have used the patch since it went on sale in 2002. Several lawsuits have been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.


Let this be a lesson to the liberals trying to rush the FDA into a decision prematurely. Interestingly, the same liberals are first in line for the lawsuits!

 

[imported_tss4]

Originally posted by: zendari
Let this be a lesson to the liberals trying to rush the FDA into a decision prematurely. Interestingly, the same liberals are first in line for the lawsuits!

You sound like a nut. Is it the fault of the republican party that the big drug companies have been under fire for some of the side affect of their drugs lately? NO, its not. And neither is this the fault of the liberals. Don't be such a political hack.

If its found to be dangerous then by all means, remove it from the market or at the very least label the dangers.

 

[zendari]

It would be much easier to determine whether a product is dangerous or not with adequate time to do the proper research, without the demands from PP.

 

[imported_tss4]

Originally posted by: zendari
It would be much easier to determine whether a product is dangerous or not with adequate time to do the proper research, without the demands from PP.

There are both conservative and liberal interest groups pushing drugs through as fast as possible. To blame one or the other is pure punditry.

 

[Strk]

Some of the appointments are raising serious concerns in the agencies themselves and on Capitol Hill about the competence and independence of agencies that the country relies on to keep us safe, healthy and secure. Internal e-mail messages obtained by TIME show that scientists' drug-safety decisions at the Food and Drug Administration (FDA) are being second-guessed by a 33-year-old doctor [Scott Gottlieb] turned stock picker.

Behind the scenes, however, Gottlieb has shown an interest in precisely those kinds of deliberations. One instance took place on Sept. 15, when the FDA decided to stop the trial of a drug for multiple sclerosis during which three people had developed an unusual disorder in which their bodies eliminated their blood platelets and one died of intracerebral bleeding as a result. In an e-mail obtained by TIME, Gottlieb speculated that the complication might have been the result of the disease and not the drug. "Just seems like an overreaction to place a clinical hold" on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication "seems very clearly a drug-related event." Two days prior, when word broke that the FDA had sent a "non-approvable" letter to Pfizer Inc., formally rejecting its Oporia drug for osteoporosis, senior officials at the FDA's Center for Drug Evaluation and Research received copies of an e-mail from Gottlieb expressing his surprise that what he thought would be a routine approval had been turned down. Gottlieb asked for an explanation.

Yeah.... such a liberal issue.....

One day you'll make a post that makes sense, Zendari.

I pretty much disagree with all of the Bush cheerleaders, but at least most of them at least try to make sense in their posts. (Well, some do, I just disagree with the conclusions )

 

[Todd33]

I wasn't aware of liberals trying to rush drugs to the market. I was aware of people being against politics in the FDA which hold up safe drugs. The FDA should not be a political or religious federal institution, but I guess crazies can blame "liberals" for everything.