Drug Products

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

County sends teams to aid South Florida

A contingent of Osceola County public-safety and electric-utility workers is helping residents in South Florida recover from Hurricane Wilma.
On Thursday, eight Kissimmee police officers left for the Miami area to provide security for Florida Power & Light Co. as the utility restores electricity in the storm-devastated area. They plan to spend a week on the assignment.
Earlier, Kissimmee Utility Authority announced that it was sending repair crews, vehicles and supplies to South Florida to help restore power.
The hurricane left 94 percent of Fort Pierce’s 25,000 residents without electricity, KUA said.
On the night the storm struck, Osceola County and Kissimmee sent 13 paramedics and emergency-medical technicians to the Florida Keys to help with hurricane recovery.
The team was to help transfer hospital and nursing-home patients in hurricane-ravaged areas to other medical facilities.
The team brought its own food, water, cots and supplies and expects to stay in Monroe County as long as 11 days.

A rip in fabric that holds law enforcement together

ike many Americans, I watched with great interest, and with increasing anger, the recent beating of a 64-year-old retired schoolteacher on the streets of New Orleans. The glare of the public eye almost wasn’t there. A New Orleans police horse appeared to be made to walk backward, apparently to block the probing eye of the TV camera.
Unlike many Americans, as a former police chief and current manager of a police academy, I have learned that the facts of alleged police misconduct are many times at odds with the information that comes out publicly. Time after time, I would investigate complaints against officers, only to find the issue to be clouded in misunderstanding or sometimes even blatant lies against an officer making a lawful and professional arrest.
However, even in the eyes of law-enforcement professionals across the nation, who tend to hold back criticism of fellow officers until the very last shred of damning evidence is in, the New Orleans situation was very disturbing. Every officer and police instructor I spoke with in different regions of the country had a similar reaction: disgust.
As the picture speaks a thousand words for itself, so, too, does the obvious crossing of the line with Robert Davis. And while there exists a sliver (and I mean a tiny sliver) that there could be some truth in the position of the arresting officers, an even more unsettling development out of the same situation was the New Orleans police officer who threatened and used profanity with an AP television producer while physically pushing him back against a car.
The blatant and open hostility vented by the officer revealed a brand of law enforcement that could not support a bona fide arrest of that producer and could offer no credible explanation for the verbal barrage of expletives and obvious physical battery. Even if the producer was subject to a legitimate arrest, the officer’s behavior was not acceptable.
When I took the oath of a law enforcer years ago, I told myself that the true measure of what separated me from the bullies and predators in our society was not my badge. Rather it was the inner strength I possessed to curb my impulses and shape my behavior so that “I” did not become “them.” The badge was but the symbol. The true manifestation of policing was within me.
And the true essence of being an honorable law enforcer is in most police officers, deputy sheriffs, and state troopers. New Orleans is a situation that stretches the thread that binds the police fabric together. It pulls at the material and frays the edges, making it easy for an officer to fall victim to his impulses to loot sunglasses or take TVs.
The hidden strength in the blue fabric should be the presence of other interwoven blue threads that lend support for those rare moments of personal weakness. It behooves the rest of us in this noble profession to see the signs of tired and stressed threads and give them support.
When the officer pushed the media producer against the car, I observed several other officers that stood by and watched. Those officers should have been the “cross thread” that gave strength to the situation and intervened. Better yet, maybe they could have foreseen the buildup and moved their colleague down the street to cool off.
The image of New Orleans police as bullies and intimidators on national television does not help the cause of an agency that has strived for some 10 years to break its negative reputation. That impetus to clean up the department’s image began with the arrival of former police Superintendent Richard Pennington (now the police chief in Atlanta) and has come full circle with the recent events.
Nor, for that matter, does it help the image of police professionals elsewhere. While all would acknowledge that the stress on the New Orleans officers during this post-hurricane period has been inordinate, the oath has no clause that makes for allowances of police abuse and brutality.
My 4-year-old son interacts with police officers regularly, pretends that he is one, and wants to be one some day. I am ashamed to say that I had to have him leave the room when the images of those officers breaking their oath came on the television again and again. My little, wide-eyed boy did not yet need to see what happens when the blue fabric that holds the law-enforcement profession together is ripped.

Saunders & Walker, P.A.

Saunders & Walker represents seriously injured or abused persons and the families of persons whose lives have been adversely affected by the negligence of others. We seek justice and compensation from corporations, organizations, and individuals who intentionally or negligently cause harm, injury, or death to our clients.
The law firm was founded in 1987 and is located in Pinellas Park, Florida were it was founded. Pinellas Park is on the west coast of Florida midway between St. Petersburg and Clearwater. A second office was opened in Bradenton, Florida in 1994.
The law firm represents individuals both in Federal and State Courts. In one Federal court case which involved civil rights and police brutality, the City of St. Petersburg paid a client of our firm the largest settlement ever by the City for any type of injury or death case. The Federal cases also involve maritime claims and products liability cases based upon diversity jurisdiction.
The State court cases include medical malpractice, automobile accident, premises liability, products liability and general negligence cases.
Mr. Saunders is a Board Certified Civil Trial Lawyer by the Florida Bar Board of Legal Specialization and Education. He is an Eagle Member of the Academy of Florida Trial Lawyers, a member of Association of Trial Lawyers of American and a member of Maritime Law Association of the United States.

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Disclaimer

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