Beware Ortho Evra Birth Control Patch Danger

Ortho Evra® birth-control patches may cause:

Increased risk of blood clots
Increased risk of heart attacks
Increased risk of strokes

The Ortho Evra® contraceptive patch delivers increased levels of hormones to the bloodstream through the skin.

The FDA says " In general, increased estrogen exposure may increase the risk of blood clots."The FDA also says "Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks."

If you or a loved one have been prescribed Ortho Evra® and have had a heart attack, stroke or blood clots, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation. Call toll free at 1-866-333-3529 now or email us at info@bagoliefriedman.com.

School Board to Test for Vinyl Chloride

The Corona-Norco school board voted Tuesday night to test the air at two local schools for a cancer-causing chemical that has been found at Norco High.

Over the next month, new science buildings at El Cerrito Middle and Corona High will be tested to see if plastics in the building are emitting a vapor called vinyl chloride.

Low levels of the same chemical have been found at Norco High for more than a year, but officials have presumed that the gas was coming from an underground plume of pollution from a nearby toxic-waste site.

However, earlier this month soil gas tests showed no link to the underground plume, prompting state regulators to consider building materials as the potential source.

Test results at the other two schools could reveal whether Wyle or the building materials are to blame for Norco High's problems. If the schools do test positive for the chemical, the district would also have to decide how to deal with the pollution.

Board member Bill Hedrick spearheaded this week's unanimous decision to test at other schools.

There is "no safe level" of vinyl chloride, he said.

"Whether they find a small amount or a large amount, it's got to be mitigated," Hedrick said. "Unfortunately, this is such a bad player you really don't want any of it."

Hedrick said mortgage companies have been reluctant to make loans for homes in the area.

"If mortgage companies look at it and go, we have questions, how much more of an obligation do we have as a school district to ensure safety?" he said.

It is not the first time the school district has grappled with hazardous materials in the schools, said Ted Rozzi, the district's assistant superintendent for facilities.

Over the past decade, the district mitigated hazardous mold and cancer-causing formaldehyde vapor from materials used to make portable classrooms. If found elsewhere, air circulation systems could help treat the vinyl chloride gas, he said.

In the meantime, officials with California's Department of Toxic Substances Control will continue to test for a link between the contamination at Norco High and the plume from Wyle Labs, a former hazardous-testing facility across the street from the school.

As for the building materials, the potential sources are the same poly vinyl tiles, carpets and wall coverings used in the other schools and in buildings around the nation. Such materials are capable of "off-gassing" -- defined as emission through evaporation.

According to the Environmental Protection Agency, vinyl chloride is a carcinogen that chemically alters DNA in ways that could lead to the development of tumors, liver cancer, brain cancer and angiosarcoma.

The levels found so far don't pose a health threat to students but could slightly increase the risk of cancer for teachers working in the building over a period of decades, said a state toxicologist.

At least four cases of leukemia among Norco High students in recent years have raised concerns about students' health.

No such illnesses or concerns have been linked to Corona High, said Patti Anders, the school's Parent Teacher Association president.

"I think it's good that they're testing," she said. "At least this way, they can find out what's causing the problem at Norco High School."


Bagolie Friedman Injury Lawyers can help victims of vinyl chloride and PVC exposure. Contact them now, toll free at 1-866-333-3529 for a confidential and free consultation.

Beware: The ORTHO EVRA PATCH - Whare the adverse reactions ORTHO EVRA causes?at

Blood clots and the birth control patch — Blood clots in the leg and blood clots lungs are behind the calls for a recall on the Ortho Evra patch.

Blood clots were the adverse reactions Ortho caused in the lungs of two women given the drug in clinical trials conducted before the drug was approved and in addition to many similar cases in women after the drug was marketed.

Adverse reactions ortho evra caused are now in the new warning. The FDA belatedly acknowledges the increased dangers of using ORTHO EVRA. These adverse reactions were first noted by the FDA physician who reviewed the drug before the agency approved it.

Despite the adverse ortho reactions that the FDA has now admitted -- that women who use the ORTHO EVRA birth control patch are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill, the FDA still allowed the ORTHO EVRA on the market and is unwilling to ban or recall it.

The problem is that hundreds of pharmaceutical lobbyists put pressure on the government to keep the drugs on the market.

Birth control is prescribed to young, healthy women and should be associated with the lowest possible risk of serious adverse drug reactions. There is no evidence that the ORTHO EVRA birth control patch is a superior contraceptive compared to older birth control pills.

The Associated Press used the Freedom of Information Act to obtain adverse drug reaction reports for ORTHO EVRA from the FDA. They reported that in 23 cases where death was the outcome, doctors found that 17 of the patients’ death appeared to be blood clot-related, including 12 from last year. The FDA estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious adverse drug reactions that actually occur, meaning that the actual rate of adverse reactions for Ortho Evra may be much higher.

Additionally, the Associated Press looked at the reviews of clinical trial results done by FDA physicians and scientists prior to the weekly birth control patch’s approval. The results were submitted for review by drug manufacturer Ortho-McNeil in support of ORTHO EVRA.

Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in young women participating in the pre-approval clinical trials were caused by the birth control patch. The FDA medical officer wrote:

The FDA reviewer did not agree with Ortho-McNeil’s above conclusions. The two blood clot cases of pulmonary embolus/PE, a serious and potentially fatal condition, must be counted as two cases in the original group. Furthermore the FDA insisted that ORTHO EVRA’s labeling include the possible risk of fatal blood clots such as venous thromboembolism (VTE).

The FDA also expressed concern that 211 out of 3,088 women ( or 6.8 percent) in the pre-approval clinical trials gained 10 or more pounds in the trials and the contraceptive effectiveness of the ORTHO EVRA birth control patch was reduced in women weighing more than 198 pounds.

Precautions to consider before taking ORTHO EVRA:
You could be at high risk for developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using the ORTHO EVRA birth control increase significantly if you:
• Smoke
• Have high blood pressure, diabetes, or high cholesterol
• Have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors

Before using the ORTHO EVRA birth control patch, you must consult your doctor and pharmacist about all the prescription drugs, vitamins, and supplements you are taking:

Are you allergic to estrogens, progestins, or other medications?

Be sure to mention any of the following: Tylenol, antibiotics, anticoagulants such as blood thinners, Lipitor, cyclosporine, HIV protease inhibitors, medications for seizures, Phenobarbital, morphine, oral steroids, thyroid medications, St. John Wort, and many more. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

In our 21st century pill popping society – drug interactions can be fatal and/or could alter the effectiveness of the ORTHO EVRA birth control patch.

Why take the risk when birth control pills are a much safer option? Women should be empowered to make the right choice for their bodies and long term health goals.

If you or a loved one has experienced problems from using the Ortho Evra Birth Control Patch, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.

Beware: Permax (pergolide mesylate) 2003 Safety Letter

Source | FDA

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285

Dear Health Care Professional,

During postmarketing surveillance for Permax®, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during Permax therapy. Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports.


In the reports made to Lilly, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients.
It is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare but well known adverse effects seen with Permax.


Since Permax was first launched in the United States in 1989, a very limited number of cases have been reported to Lilly and to the FDA. Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.


Based on these reports, the Warnings section of the US Package Insert for Permax will be modified as follows (new wording underlined):
Serous Inflammation and Fibrosis–There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.


If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.
Sincerely,
Valerie E. Simmons, MD, FFPM
Director
Worldwide Pharmacovigilance and Epidemiology
Eli Lilly and Company
Permax® is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Please see accompanying Prescribing Information. Permax is a registered trademark of Eli Lilly and Company, and is licensed exclusively in the United States to Amarin Pharmaceuticals, Inc.


Do I Have a Permax or Dostinex Lawsuit?

If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects, you should contact Bagolie Friedman Injury Lawyers immediately for a free and confidential consultation.

Blood Thinner Medication Warfarin Linked To Brain Bleeds In Elderly

(Posted by Tom Lamb at DrugInjuryWatch.com)

The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage. Warfarin is sold under various different brand names, with one of the more popular being Coumadin.

According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:

Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.

"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.

As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain. By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.

The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:

One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.

"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.

Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.

Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.

In closing, we want to make an important point: As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.

Bagolie & Friedman Lecture to Lawyers on Workers' Compensation Practice

New Jersey - December 2006 - Workers' Compensation Trial Lawyers Ricky Bagolie and Alan Friedman were invited to speak to a group of lawyers interested in advanced workers' comp trial tips. The unique program took place on December 2 at Pines Manor in Edison and was sponsored by the Association of Trial Lawyers of America - New Jersey (ATLA-NJ). It featured a panel of some of the most respected workers’ compensation attorneys in the state.

The program was packed with practice pointers that have proven successful in matters ranging from Using Epidemiology to Cross Examining Defense Experts, Post Settlement Enforcement Motions, Navigating the Latest Lien Issues and the Ethical Considerations in Dealing with Problem Clients. "Attendees took home new ideas that they could immediately apply to their current and future cases", said Bagolie.

Ricky Bagolie and Alan Friedman have lectured to attorneys locally, nationally as well as internationally and are the founding members of Bagolie Friedman Injury Lawyers, of Jersey City & Clifton, NJ and affiliate offices in Hollywood, Florida and Brisbane, Australia may be reached toll free at 1-866-333-3529, via e-mail at info@bagoliefriedman.com