ORTHOEVRA BIRTH CONTROL BLOG

Evelyn Pringle: Add Triaminic Vapor Patch To List Of Deadly Patches

June 30, 2006

Novartis Consumer Health issued a recall for the cough-suppressing Triaminic Vapor Patches in the US, about three weeks after Health Canada issued a warning after a Canadian child who chewed on a patch suffered a seizure.

There have been 8 adverse events with the patch, all involving ingestion, Navartis spokesperson, Julie Masow, told the Philadelphia Inquirer on June 21, 2006.

The patches were sold over the counter at pharmacies and retail stores and Novartis said it has sold more than 50 million vapor patches since they came on the market in 2000.

The Swiss drug maker warned consumers to stop using the patch immediately and said they should either be discarded or returned to the place of purchase for a full refund.

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as 2 years-old. Novartis said the placement of the patch can allow children to remove them and place them in their mouths. It is difficult to believe that the idea never occurred to the drug maker that a 2 year-old would attempt to pick the cherry-scented patch off and eat it.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, nausea, headache, vomiting and seizure. Other complaints received by the company associated with the patch include reports of blistering, bruising, scarring, hyperactivity and depigmentation.

Whether the patch will remain off the market is not known. According to a June 21, 2006, Press Release by the LecTec Corporation, in January 2004, LecTec entered into a Supply and License Agreement with Novartis under which LecTec licensed certain of its patents to Novartis for the production of vapor patches.

In response to a question from LecTec, a representative of Novartis indicated that no decision had been made whether to reintroduce the product in certain markets, although the patches would definitely not be reintroduced for use by young children, the press release said.

The royalties received by LecTec under this agreement represented substantially all of the firm’s revenues in fiscal 2005, as well as the first quarter of fiscal 2006. The specific patch that caused the seizure was not manufactured by LecTec, according to Novaris quoted in the press release.

Over roughly the past 25 years, patch medications have become a booming business for Big Pharma. More than 30 different types of patches have been used by 12 million people worldwide for conditions ranging from birth control to heart disease to chronic pain to bladder control. The first antidepressant patch was approved by the FDA this month.

In 2004, patch sales totaled about $3.4 billion, according to the medical market research firm Greystone Associates.

All medication releasing patches work the same, according to Bozena Michniak, who studies transdermal patch delivery systems at the Center for Biomaterials at Rutgers University. The medication seeps through the skin into the bloodstream, and the increased blood flow causes the body to absorb the drug.

As more versions of the medication patches are introduced on the market, medical experts say that many of them are unsafe. Multiple studies have shown that heat has a dangerous effect on the patches, whether from a high fever, exercise or a hot tub. Heat increases the absorption rate of the medication and sometimes with fatal results.

As far back as 1986, a study found that just 20 minutes of bicycling with a nitroglycerin patch increased concentration of the drug two to threefold. Similar results were found after 30 minutes in a sauna, according to an article in Philly.com on March 5, 2006.

But yet there was no public warnings added to the Fentanyl pain patch until 36-year-old Kurt Hophan died in Pennsylvania on March 4, 1994.

Fentanyl, a schedule II narcotic analgesic, is roughly 50-80 times more potent than morphine and is used to manage both pain during surgery and for persons with chronic moderate to severe pain who already are physically tolerant to opiates, according to the US Center for Substance Abuse Treatment.

Mr Hophan applied the patch for pain relief associated with a back injury and went to his bedroom in his mother’s home and fell asleep with a heating pad and an electric blanket.

When the heat from the pad and the blanket came into contact with the patch, the amount of Fentanyl released into Mr Hophan’s bloodstream was estimated to be about 100 times greater than the amount prescribed, according to a judge’s opinion in a lawsuit filed by Mr Hophan’s mother, Elaine Hophan, against the drug’s maker.

In 2001, a jury awarded Ms Hophan $5 million in damages but after an appeal, the case was settled under a confidential settlement agreement.

Fentanyl patches are sold under a variety of brand and generic names. Johnson and Johnson’s Duragesic was the first on the market arriving in the early 1990s. It’s the most popular patch with four million prescriptions filled at US pharmacies last year.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to J& J’s earnings reports. The cost of a 30-day supply ranges from $348 at Target to $408 at Wal-Mart, according to FDA documents.

On April 5, 2004, J&J issued a recall for defective patches that applied to specific lots of patches, which had a faulty seal that permitted Fentanyl to seep from the patch, resulting in patients being given an overdose of Fentanyl.

On July 15, 2005, the FDA issued a public health advisory about the proper way to use the Fentanyl patches to avoid overdose, in response to reports of deaths in patients using the narcotic patch for pain management.

The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch: 127 deaths over the last six years, according to a CBS News report on December 20, 2005.

“They’re not getting the relief that they want. Therefore they’re slapping more patches on trying to get that instantaneous relief,” says toxicologist Daniel Anderson. “What they don’t realize is that most of these patches are to be applied over a three-day period.”

Utah statistics according to the latest mortality data from the state Health Department show Fentanyl was related to 29 accidental deaths in 2005, up from nine in 2004, and 13 in 2002, according to the March 14, 2006 Salt Lake Tribune.

Lawsuit are being filed as a result of the high accidental overdose rate. Robert Debry & Associates, in Salt Lake City has taken about a dozen cases involving deaths allegedly from Fentanyl. One lawsuit is filed on behalf of the family of Marilyn Titus who died December 14, 2003, at age 72 and alleges Ms Titus, was suffering from severe back pain, and was sold defective and leaking patches.

In December 2005, surviving family members of two more Utah women filed wrongful death lawsuits, alleging the patches leaked and caused the deaths of both women.

Autopsy reports said the women died from drug poisoning after using pain patches. Both lawsuits claim the women were prescribed the patch and were found dead in their homes within one or two days of using the patch.

Both lawsuits claim negligence for failing to research and design the patch and allege the companies misrepresented the safety of the patch for human use.

Overall, US emergency room doctors saw overdoses of Fentanyl grow from 28 in 1994 to 1,506 in 2002, according to the most recent statistics available from the US Substance Abuse and Mental Health Administration.

In March 2006, the FDA announced it would conduct a review of all medication patches beginning with Fentanyl and the Ortho Evra birth control patch, also made by J& J.

The following month, an April 10, 2006, Long Island Newsday report said that “hundreds” of women had filed lawsuits against Ortho-McNeil, the J&J division that manufactures the Ortho Evra patch.

And there will no doubt be many more filed against the company because in 2005, doctors wrote more than 9.4 million prescriptions for the birth control patch, according to IMS Health, an pharmaceutical industry monitoring firm.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.

In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.

A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.

Around the time the company introduced the patch to the market, the lawsuit claims, Ortho’s patent for its contraceptive pill, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue.

In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.

The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.

Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA

The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.

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Free Prescription Drug Plan Helps Cover Birth Control Costs When Insurance Won’t

June 28, 2006

Many American women are still faced with paying for the cost of prescription birth control out of their own pockets, because their insurance companies don’t cover the drugs. The new free prescription drug card available through www.YourRxCard.com helps these women by offering a discount on prescription birth control in the same method as their discounts on any other prescription drugs. The free card can also be used with insurance plans to help the patient receive the lowest prescription drug cost possible.

as of February 2006, [only 23 states require insurers that cover prescription drugs in general to provide coverage of the full range of FDA-approved contraceptive drugs and devices.
Cover My Pills, sponsored by Planned Parenthood’s Fair Access to Contraception (FAC) project, states that nearly 70% of American women in their childbearing years (”age 15-44 on average”), are sexually active and do not wish to become pregnant at the current time. The organization also shares that 95% of women in the US use some kind of contraception during their lifetime, and more than half of those women use prescription birth control.

Yet, even with the high demand by American women for prescription birth control, Cover My Pills reports that “as of February 2006, [only 23 states require insurers that cover prescription drugs in general to provide coverage of the full range of FDA-approved contraceptive drugs and devices.” While the number of insurance companies covering prescription birth control drugs has improved in recent years, this demonstrates the fact that coverage is still a problem for women in many areas. The free prescription drug card from aims to serve as a simple solution to this complex and debated problem.

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Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of 37-Year-Old Woman Diagnosed with Bilateral Pulmonary Emboli After Using Ortho Evra Birth Control Patch

June 26, 2006

On June 17 2005, the injured woman was admitted to Piedmont Hospital in Atlanta, Georgia after experiencing intense lower chest pain on her left side. Diagnostic tests revealed a bilateral pulmonary embolism. Anticoagulation therapy with Coumadin and Lovenox was immediately administered. There is a strong likelihood that prolonged, or even permanent, treatment with blood thinners will be necessary.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA’s announcement on this warning can be found at http://www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but they can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestral. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17 month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six year period.

During a 12 month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that is worn on the torso. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products.

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Ortho-McNeil sued on birth-control patch

June 20, 2006

he New York-based law firm Parker & Waichman said it is suing Ortho-McNeil — a division of Johnson & Johnson — on behalf of a 37-year-old woman and her husband.

The plaintiff’s complaint — filed in a New Jersey District Court — alleges she suffered a bilateral pulmonary embolism after using Ortho Evra for just over one year.

The plaintiff claims she suffered the injury June 17 of last year and had to be hospitalized.

“There is a strong likelihood that prolonged, or even permanent, treatment with blood thinners will be necessary,” Parker & Waichman said in a statement.

In November 2005 Ortho McNeil and the Food and Drug Administration issued a warning about an increased risk of blood clots associated with Ortho Evra, the firm noted.

“In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60 percent more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen,” Parker & Waichman said.

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OxyContin Maker, Insurer Settle Legal-Bill Dispute

June 14, 2006

Word Count: 642 | Companies Featured in This Article: Zurich Insurance, Merck , Pfizer, Johnson & Johnson
Purdue Pharma L.P. has settled a civil case brought by its insurer over spiraling legal costs incurred by the drug company in defending nearly 1,400 lawsuits over OxyContin, its prescription painkiller.

The insurer, Steadfast Insurance Co., a unit of Zurich Insurance Co. of Switzerland, had balked at paying more than $400 million in OxyContin-related defense costs Purdue has generated in defending consumer claims that OxyContin is addictive. Underlying the insurance dispute: 200 boxes stuffed with paper invoices of Purdue’s legal costs for defending the OxyContin cases, none of which has gone to trial.

The truce came on the eve of …

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Evelyn Pringle: Ortho Evra Patch Maker Johnson & Johnson Waves A White Flag

June 8, 2006

On May 2, 2006, Johnson & Johnson attorney, Susan Sharko, wrote to New Jersey Superior Court Judge, Peter Bariso, to inform the court that the company had reached confidential settlements with 11 of the 12 plaintiffs involved in litigation in New Jersey.

Less than a month earlier, on April 9, 2006, the New York Post reported that women who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch were already receiving cash settlements from the manufacturer.

“Ortho-McNeil Pharmaceutical,” the Post wrote, “a subsidiary of Johnson & Johnson, has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending.”

With J&J waving a white flag this early in the game, the litigation period involving the Ortho Evra birth control patch may go down in history as being the shortest ever against a drug company.

However, many more cases are pending in other federal and state courts. On March 1, the Judicial Panel on Multidistrict Litigation issued a transfer order and appointed a federal judge in Ohio to oversee the consolidated pretrial proceedings of 13 federal products liability suits filed by plaintiffs in different states over the Ortho Evra patch.

The JPML assigned the 13 cases to US District Judge David Katz of the Northern District of Ohio, who was already handling the first federal lawsuit over the Ortho patch.

That case, Bernard v Ortho-McNeil Pharmaceuticals, is “progressing well,” the Panel said, and the Ohio venue would provide a relatively central situs in regard to the geographic dispersal of the constituents and tag-along cases..

As of March 1, 2006, the Panel said it had been notified of 54 potentially related actions pending in the multiple federal districts and said, these actions will be treated as potential tag-along actions.

The Panel noted “that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.”

“Among other things,” the Panel wrote, “these action share allegations that i) the Ortho Evra contraceptive patch was defectively designed, and ii) plaintiffs received inadequate warnings regarding Ortho Evra’s side effects and safety profile.”

“All actions seek damages for personal injury and/or economic damages on behalf of users of Ortho Evra,” the Panel wrote, “asserting various state law claims, such as negligence, products liability, breach of warranties, and negligence and/or fraudulent misrepresentation regarding the risks of using Ortho Evra.”

“Centralization,” the Panel said, “is necessary in order to eliminate duplicate discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary.”

However a white flag has already been waved at many of the plaintiffs in these cases as well. On May 2, 2006, at the very first status conference held by Judge Katz, Johnson & Johnson attorney, Robert Tucker, stated the company was prepared to settle suits in which plaintiffs were hospitalized for heart attacks, stroke, pulmonary embolisms or deep vein thrombosis, according Charles Toutant, in the May 16, 2006 New Jersey Law Journal.

Ellen Relkin, of Weitz & Luxenberg in South Orange, NJ, a member of the plaintiffs’ executive committee for the federal suit, In re Ortho Evra Products Liability Litigation, told the Journal that “many of these cases are seven figures, many are probably substantial six-figure cases.”

“It’s not like a Vioxx, where you have clients in their 50s, 60s, 70s,” explained David Eisenbrouch, of Balkin & Eisenbrouch, who represents plaintiffs. “You’re dealing with primarily very young women, and J&J would rather cut its losses,” he told the Journal.

Less than 2 weeks later, on May 13, 2006, Bloomberg News reported that J&J has settled lawsuits with about 30 women quoting Attorney, Ray Chester, the lawyer who negotiated the confidential agreements.

J&J settled state courts cases in Texas, New Jersey, and California and federal courts in North Carolina and Pennsylvania, Mr Chester said.

One settlement involved Philomena Ugochukwu, 40, who had a massive stroke after wearing the patch for 12 days, he said.

The mother of two is now a quadriplegic with brain damage and needs round-the-clock care, Mr Chester told Bloomberg. She was his first Ortho Evra client.

“Johnson & Johnson is going to lose most of these cases,” he warned. “The cost to defend them and the public relations hit they would take if they tried the cases,” he advised, “has tilted them toward settling.”

The early settlement offers are no doubt due in large part to the damning internal documents that have surfaced that show the company was aware of the lethal dangers of the patch but kept right on selling it in pursuit of the almighty dollar.

For instance, on November 11, 2005, the Associated Press reported that documents “released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA’s death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.”

“In addition,” the report said, “an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’â€?

According to FDA records obtained in July 2005, by the Associated Press with a freedom of information request, over a 71 month period, there were 1,237 adverse event reports by women taking the pill, but over an 18 month period, there were 9,116 adverse event reports by women using the patch, which means there were over seven times more adverse event reports with the patch.

The AP found that before the patch was approved, the FDA had already noticed that blood clots with the patch were 3 times more common than with the pill. In 2000, FDA doctors reviewing the clinical trials submitted by the company warned that blood clots could be a problem if the patch was approved. In those trials, the doctors found that 2 of the 3,300 women using the patch were treated for blood clots that traveled to their lungs.

The reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.â€? But it didn’t and there were no requirement for follow-up studies other than routine reviews of voluntary reports called in by doctors, consumers, and the drug company.

Experts say the dangers with the patch stem from how it works in that rather than digestion and metabolization of the hormones like with the pill, the patch releases the hormones directly into the blood stream, leaving a significantly high concentration of hormones in the body.

In fact, the FDA advisory in November 2005, said users of Ortho Evra are exposed to about 60% more estrogen in their blood than if they were taking a birth control pill.

According to the complaints in many of the lawsuits filed, beginning on May 1, 2002, the FDA received 44 reports of clot-related injuries or deaths caused by the Ortho patch, but only 17 similar reports during the same time period for J&J’s Ortho Tri-Cyclen birth control pill, even though the pill was used by close to six times as many women.

However the statistics are known to be inaccurate because FDA officials acknowledge that as few as 1 to 10% of all serious side effects are ever reported to the agency so the number of clot related adverse events reported would have to be multiplied many times over to get an actual account of the cases.

According to a CBS news report in November 2005, based on documents that had surfaced in litigation, the drug maker’s own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while only 61 reports were received on all types of birth control pills.

In addition, there were four times as many strokes in women on the patch compared to women taking the pill even though 3 times as many women were taking the pill.

Overall, in medically confirmed cases, the risk of clots was estimated to be 14 times higher with the patch.

And yet, according to the complaint filed in the California case of Thoren v Johnson and Johnson, filed on January 20, 2006: “The various sales messages sent to health care providers failed to warn that the patch carried a higher risk of blood clots than oral contraceptives and actually implied that the patch carried the same risk as a pill.�

Injuries listed in many of the complaints are defined in medical terms by the National Institute of Neurological Disorders and Stroke, with thrombosis being the formation of a clot within a blood vessel of the brain or neck, and embolism defined as the movement of a clots to another part of the body such as the heart to the neck or brain and can kill depending on where they lodge in the body.

All hormonal birth control products are known to increase the risk of blood clots because estrogen promotes coagulation. Clots are semisolid masses of blood tissue that form as a result of coagulation. When clots break off into the bloodstream they can block the blood flow to other areas of the body.

Common symptoms for blood clots can include, but are not limited to, pain in the calf, shortness of breath, chest pain, or coughing blood.

If a clot is lodged in the brain, a stroke can occur when the brain does not receive an adequate amount of oxygen. Symptoms of a stroke include sudden: (1) numbness or weakness of face, arm, or leg, especially on one side of the body; (2) confusion, difficulty speaking, or understanding; (3) trouble seeing in one or both eyes; (4) difficulty walking, dizziness, or loss of coordination; and (5) severe headache with no apparent cause

Milder symptoms may include drowsiness, double vision, drowsiness, nausea, or vomiting.

Attorneys say the plaintiffs in these cases have a “signature disease,” meaning a condition that is closely linked to use of the product but is otherwise rare. In this instance, blood clots are highly unusual in women of childbearing age.

The 7 lawsuits reported in the January 30, 2006 Madison St Clair Record, filed in in US District Court for the Southern District of Illinois on January 23, 2006, allege the drug maker knew about the problems with the patch but failed to warn the plaintiffs about the risk of blood clots and include the following claims and injuries by plaintiffs:

Maral Annayeva suffered from bleeding, heart pain, headaches, nausea and general malaise.

Brandy Houk suffered shortness of breath, fatigue, excessive bleeding, and passed large clots as a result of use of the patch.

Melody Miller suffered multiple blood clots which resulted in the miscarriage of her child in the fifth month of pregnancy.

Tanya Lowe suffered blood clots in her right leg that shattered and spread to her lungs.

Reannon Tutkus suffered blood clots.

Stephanie Curtis discontinued the patch and immediately became pregnant and developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.

Kristine Bailey suffered blood clots, dizziness and fatigue.

The plaintiffs in the above cases also allege that the drug maker violated the Illinois Consumer Fraud Act by the use of false and misleading misrepresentations in the marketing, promotion and sale of the patch.

The injuries described in women all across the country who have been injured by the patch mirror each other as evidenced by the following cases:

In La Cross Wisconsin, 8th grader, Alycia Brown, died of blood clots in her lower pelvis.

A woman in Maine suffered from a blood clot in her right lung.

An 18-year-old student, Zakiya Kennedy, died in a New York subway station.

In Indiana, a 12-year-old girl was diagnosed with deep-vein thrombosis.

In Missouri, Rachel Cook, 22, experienced chest pains and was hospitalized for blood clots in her lungs.

In California, doctors found a blood clot in the lung of 37-year-old Stephanie Sanchez after she experienced bad cramping in her chest.

In Glen Carbon, Illinois, Jennifer McNichols had to undergo anti-coagulant therapy and vascular surgery because of clots in her right calf and thigh.

Seventeen-year-old Laurie Swanson died after suffering a stoke in August 2004.

In Georgia, Lydia Lilly, 35, experienced pain and difficulty breathing and suffered a pulmonary embolism

In Wyoming, 25-year-old, Kathleen Thoren died when a blood clot caused a fatal amount of pressure on her brain.

In New York, a 25-year-old mother of two, Sasha Webber, died of a heart attack.

And there are bound to be thousands more suits filed because J&J reportedly sold 5 millions Ortho patches to women since the product came on the market in 2002. According to its 2005 annual report, all total J&J sold $1.1 billion in contraceptives last year.

Attorneys warn that medical professionals had better think twice before prescribing the patch because any doctor writing a prescription for it after the November 10, 2005, FDA warning, they say, could very well be considered irresponsible in terms of accepted medical practice if an otherwise healthy young patient is paralyzed or dies after using the device.

Injured parties can find more information at Lawyers and Settlements.com.

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Report Shows Popular Birth Control Pill, Ortho Tri-Cyclen(R) LO, Not Associated With Increased Pregnancy Risk In Heavier Women

June 5, 2006

Main Category: Women’s Health / OBGYN News
Article Date: 11 May 2006 - 0:00am (PDT)

The popular birth control pill, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) Tablets, is not associated with an increased risk of pregnancy in heavier women, according to findings(1) presented today at the 54th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).

Previous research suggested that higher weight or body mass index (BMI) may compromise the efficacy of birth control pills leading to a greater number of unintended pregnancies.(2,3) This analysis evaluates the risk of pregnancy in heavier women using ORTHO TRI-CYCLEN LO.

“A significant number of women with a wide range of weights and BMIs were included in this analysis, creating a rich source of data to evaluate the association between body weight and efficacy,” said Dr. Katherine LaGuardia, director, medical affairs, Ortho Women’s Health & Urology. “These results reinforce ORTHO TRI-CYCLEN LO as an effective birth control option for women in a broad range of body weights.”

Study Details

The report is based on a retrospective analysis of ORTHO TRI-CYCLEN LO Phase III efficacy data to determine the association of pregnancies with body weight and BMI, a standard measure of weight-for-height. The data were from 1,673 ORTHO TRI-CYCLEN LO users, weighing from 90 to 240 pounds, for 11,003 use cycles.

Investigators found that a total of 20 pregnancies occurred - 14 likely due to “method failure” (eg, the Pill did not work) and six due to failure on the part of the individual (eg, forgetting to take the Pill). This translated into a total pregnancy probability of 1.9 percent and a probability of failure of the Pill of 1.5 percent.

The probability of total and method-failure pregnancies was the same across different body weights. ORTHO TRI-CYCLEN LO users weighing 155 lbs. or more (n=435) did not experience significantly higher pregnancy risk than those less than 155 lbs. with either method-failure pregnancies (relative risk 1.03, p=0.95) or total pregnancies (relative risk 1.42, p=0.46). The results were the same when other weight criteria (median weight of 139 lbs. and over vs. less than 139 lbs., over 175 lbs. vs. less than or equal to 175 lbs., and 198 lbs. and over vs. less than 198 lbs.) and BMI criteria (25 and over vs. less than 25) were applied. The study was conducted and funded by Ortho Women’s Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc.

About ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.

Important Safety Information

Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives are strongly advised not to smoke. The Pill does not protect against HIV or sexually transmitted diseases.

For more information about ORTHO TRI-CYCLEN LO, please visit http://www.thepill.com.

About Ortho Women’s Health & Urology

Ortho Women’s Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc., is a leader in the fields of women’s health and urology and is committed to providing patients with products that help them to live healthier lives. Ortho Women’s Health & Urology, a trusted partner of healthcare professionals, is committed to meeting the needs of providers and patients with products such as ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system), ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), DITROPAN XL(R) (oxybutynin chloride), and ELMIRON(R) (pentosan polysulfate sodium).

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A life without periods?

June 3, 2006

Jennifer Burch has seen the ads for Seasonale, Barr Pharmaceutical’s new packaging of the standard birth control pill available in the US that promises users just four periods a year.
But, she said, she’s not buying it.

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“Let the body do what it does naturally,” said Burch, a 32-year-old yoga instructor who said she was in the midst of her monthly period at the time, with its usual bothersome mood swings.

“If we weren’t meant to have periods - if for some evolutionary reason that made the most sense and was the healthiest - then we wouldn’t have them,” Burch said from her home in New York City. “I say, let the energy flow.”

Susan Greenhalgh, a 40-year-old chemicals broker from Amityville, New York, has also put up with the physical and emotional hassles that come with periods. But, she said, she has her suspicions, too.

“As much as I would love to not be bothered by a monthly period, I can’t believe that manipulating hormones and your body’s natural cycle to that degree could be healthy,” Greenhalgh said.

Experts say it is safe
And yet gynaecologic experts say putting an end to the period is safe, and that the growing popularity of interventions such as Seasonale - whose sales jumped 62 percent last year to over $110 million - shows there are a lot of American women willing to take that step.

“I believe that most women would really like to get rid of their period,” said Dr Camelia Davtyan, an expert in women’s health and assistant professor of medicine at the University of California, Los Angeles, Medical Centre. She pointed out that any woman who is on the Pill ceased having a real period long ago, anyway.

Period on the pill is not natural
“When women are on the Pill and have a period, it’s not a natural period - there was no actual maturation or transformation of the lining of the uterus,” Davtyan said. Instead, gynaecologists call it “withdrawal bleeding.” This bleeding only occurs because the uterine lining experiences a sudden drop in progestin during the placebo week, Davtyan explained.

And the Pill’s 7-day placebo “break” was arbitrary in the first place, she added.

“There’s an anecdote that’s floating around the gynaecologic world that when the Pill was first introduced 40-something years ago, it was made by a bunch of guy gynaecologists,” Davtyan said. “They just thought women would be much happier to have something closer to their natural period, rather than to have no periods at all.”

Dr Shari Brasner, an obstetrician/gynaecologist affiliated with Mount Sinai Hospital, in New York City, said she’s used the conventional Pill continuously - without the 7-day break - for years. She said opting for a life without periods has left her with no regrets.

“I have an incredibly busy day, and I was never the kind of woman who, quite frankly, had a rigid enough schedule that I could remember to go into the bathroom and deal with issues involving periods,” Brasner said. “I did it on the basis of understanding what the pills were and believing that they were safe.”

Placebo not really required
Indeed, gynaecologists have been prescribing “continuous” birth control pill regimens for decades to help women struggling with problems such as endometriosis. And, Brasner said, new products like Seasonale simply stretch the number of days women take the active pill.

In Seasonale’s case, women take the hormonal medication for 12 weeks at a time with a one-week placebo break 4 times per year, when the user experiences “withdrawal bleeding.”

“And that placebo week, quite frankly, was only added to just be more acceptable to the user,” Brasner said. “The concept of going from 12 or 13 periods per year down to none was a huge [mental] leap, so they’ve tried to soften that by still giving women that occasional withdrawal bleeding. It doesn’t serve any true medical purpose, though,” she added.

Seasonale is just the first of many period-suppressing products to hit the market. Drug maker Wyeth is hoping to receive US Food and Drug Administration approval next month for its continuous low-dose contraceptive pill, Lybrel; Berlex Inc. has its own version poised for launch; and Organon USA is hoping to receive an FDA heads-up within the next few weeks for Implanon, a single-rod, three-year contraceptive implanted in the upper arm that’s been used by European women for more than a decade.

Just last week, the FDA announced its approval of Barr’s successor product to Seasonale, a long-term contraceptive called Seasonique.

Various long-term options
Other long-term contraceptive devices currently available in the United States include NuvaRing, a three-week vaginal contraceptive ring, the Ortho-Evra patch, and Pfizer’s injectable three-month contraceptive Depo-Provera.

While long-term use of Depo-Provera can cause thinning bones, Davtyan said other hormone-based contraceptives do not pose bone risks. “Remember, oestrogen is actually good for bones,” she said.

“As for low-dose pills, the main side effect is blood clots,” she said. “But whether a woman decides to take the Pill for 21 days or continuously for 28, most likely she will have a similar blood-clot risk.” The absolute risk for any healthy, non-smoking woman for a Pill-linked blood clot remains extremely low, experts say.

Contains nothing new
According to Brasner, the take-home message for women is that these new hormonal contraceptive regimens contain “nothing new. We have had traditional birth-control for 40-some-odd years, and, overall, I think their safety has been proved.”

But, if that’s true, why are women like Burch and Greenhalgh resistant to the idea of a life without periods?

“I guess there is something about femininity and periods that kind of goes together psychologically,” Davtyan said.

Not really what I want
Brasner agreed. “That’s definitely been the biggest barrier to getting women to accept this,” she said. “Even once I tell them that I firmly believe in its safety, and that I have used this myself, many of my patients will say, ‘Yes, I hear you, I believe you - but it’s not really what I want.’ ”

And both experts said that’s totally fine with them.

“The bottom line is that [period suppression] is a safe thing to do, but it should be optional,” Davtyan said. “Women should simply be given the option of having a monthly period, or a period once every three months, or not at all. Then they can decide.” – (HealthDayNews)

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