Navigation Links
Contraceptive Patch Carries Risk of Blood clots

The U.S. Food and Drug Administration on Wednesday reported having updated the warning label on the Ortho Evra birth-control patch, cautioning users about the higher risk of blood clots from it.//

The drug manufacturer Johnson and Johnson’s commissioned study revealed that drug users faced two times the risk of clots in the legs and lungs compared to women taking traditional birth-control pills.

Another study commissioned by Johnson and Johnson, however, found no difference in risk between the patch and the pill. The FDA said, "Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women."

Dr. Daniel Shames, the acting deputy director of FDA's Office of Drug Evaluation in the Center for Drug Evaluation and Research, said, "Blood clots occurring in the legs or lungs are serious and rare events that are a potential risk for all hormonal contraceptive therapies."

Shames said that risk factors for blood clots associated with contraceptives include smoking, inactivity, obesity, surgery and high doses.

The FDA has also required Johnson and Johnson to conduct a longer follow-up study of women using the patch to check for developments of heart attack, blood clots and stroke. Currently, the FDA believes the patch is safe for most women. Shames said, "Ortho Evra risk profile is acceptable for a highly effective contraceptive."

However the FDA’s concerns about the potential risk of blood clots in some women could not be ruled.

Earlier information that had been reported by Johnson and Johnson in a Feb. 16, 2006, press release was also included in the label change. This information was partly based, on an interim report from one of the two studies. The FDA said that the label change announced on Wednesday is based on the latest results from the two studies.

According to the label change women using the weekly patch which is the only birth-control patch approved by the FDA is taking in substantially more estrogen than women who take a daily birth-control pill. These pills typically contain 35 micrograms of estrogen. These higher levels of estrogen put some women at increased risk of blood clots.

Dr. Steven R. Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine said, "When the patch came out, I enthusiastically used [it] in women who don't like to take pills. But I thought that there was too much estrogen in it, because four of the women lasted one or two months and complained of symptoms, which are usually attributed to excess estrogen."

He added, "My advice is that for a patient who had been on the patch for any period of time and is doing well, I don't see a need to take her off. With most of the estrogen-related blood clots, the risk is greatest in the first six months of use."


NL
'"/>




Related medicine news :

1. Contraceptives via Internet
2. FDA Approves Contraceptive Ring
3. Contraceptives decreases Libido
4. Contraceptives have dual effects
5. Drugs For Anthrax May Interfere With Oral Contraceptives
6. Contraceptive pill to reduce PMS
7. Smoking and Oral Contraceptives:
8. Contraceptive pills may lead to deformities in babies
9. Low-Dose Oral Contraceptives May Increase Risk For Heart Attack Or Stroke
10. Prevent Multiple Sclerosis From Oral Contraceptives
11. Usage Of Oral Contraceptives Need Not Be Feared By SLE Patients
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
(Date:6/25/2016)... D.C. (PRWEB) , ... June 25, 2016 , ... ... discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, ... their work on several important health care topics including advance care planning, healthcare ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
Breaking Medicine Technology: