Monthly Archives: November 2005

FDA Issues Warning About Birth Control Patch

On November 10, 2005 the FDA issued an “updated lablelling” concerning possible adverse health effects of using the Ortho Evra birth control patch. Here is the warning issued by the FDA:
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.
FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm

FDA Issues Warning About Birth Control Patch

On November 10, 2005 the Food and Drug Administration issued an updated labeling concerning Ortho Evra, the birth control patch used by many women. Here is the statement released by the FDA:
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.
FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm

Bishop Nevins Earned a Reputation

As a former priest and Auxiliary Bishop of Miami, Bishop John Nevins of Venice knows where most of the clerical skeletons are buried in South Florida. Nevins, a NY native, has gained an ignominious reputation for accepting priests accused of child rape and child sexual abuse. After returning from the Dallas bishops’ meeting in 2002, Nevins vowed to lead the way in bringing healing to the church. Yet, in the midst of all the talk of sweetness and light he neglected to mention that some 15 years earlier he had accepted for service in his diocese a priest credibly accused of abusing a 15 year old boy in Louisville Kentucky. Of course, the infamous case of Fr. Ed McLoughlin who was finally removed from ministry after Nevins ignored victims’ cries for help, can’t be left unmentioned. Nevins was part of the same Archdiocese of Miami that allowed the Rev. Rocco D’Angelo to move from Miami to St. Petersburg without a word of warning to the authorities in St. Petersburg. D’Angelo had had a long career of molestation and Miami so when Miami church officials had had enough they sent him packing with high recommendations for priestly service. When he arrived in St. Petersburg, he continued his reign of terror and molested more young boys. As an Auxiliary Bishop in Miami, Nevins was taught the subtle nuances necessary in covering up for abusive priests and transferring them to new dioceses. No wonder the Diocese of Venice is known as a “priestly dumping ground”.

Motorcyclist dies in I-Drive crash

ORANGE COUNTY — A Kissimmee man on a motorcycle died Wednesday afternoon on International Drive in what witnesses told investigators was possibly a street-racing accident.
Gabrail Montanez, 28, was riding a 2005 Kawasaki motorcycle south on International Drive south of Central Florida Parkway about 4:45 p.m. Beside him, Christopher Jones, 27, of Orlando was riding a 2005 Yamaha.
Montanez tried to move left to pass a Ford pickup driven by 41-year-old Matthew Burns of Orlando but clipped the back of the truck, said Trooper Kim Miller, a Florida Highway Patrol spokeswoman.
Montanez was airlifted to Orlando Regional Medical Center, where he was pronounced dead. He was not wearing a helmet.
Jones and Burns were not injured.