Paxil Information and Warnings

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Paxil Information and Warnings

Paxil is a selective serotonin reuptake inhibitor (SSRI) approved for treatment of depression and several related disorders in adults. Paxil is not approved by the FDA (Food and Drug Administration) for treatment of children, because studies presented to the FDA have not shown that Paxil is effective for treating children under 18.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Paxil has been implicated in several serious and often life-threatening side effects including suicide, birth defects, and terrible withdrawal symptoms in patients and infants whose mothers took Paxil during pregnancy. A March 2006 study linked Paxil and other SSRIs to a new form of birth defect. The study, published in the New England Journal of Medicine, found that infants born to mothers who took SSRIs, including Paxil, in the last half of their pregnancies were 6 times more likely to develop persistent pulmonary hypertension (PPHN). Infants with PPHN don’t get enough oxygen and require intensive care to survive. Around 10 to 20 percent die soon after birth and some survivors suffer from deafness and neurological problems.
A 2005 FDA warning also implicated Paxil in congenital malformations. (See Drug Warnings: Paxil Side Effects and Risks) Two studies in 2005 indicated that Paxil was more likely to cause side effects than other drugs in the SSRI category. A September 2005 study presented to the FDA showed that there was a higher risk of major congenital malformations in infants whose mothers took Paxil during the first trimester of pregnancy than with other SSRIs.
Paxil, along with all the other SSRIs has been linked with suicide and suicidal thoughts in children, adolescents, and adults. An August 2005 study from Norway found that Paxil presented a higher risk of suicide in adults than other drugs.
Paxil and other SSRI drugs are often prescribed under the American Psychiatric Association treatment guidelines, which say, “most moderately and severely depressed patients will require medication.” A 2005 study led by Pennsylvania psychologist Robert DeRubeis and Steven Hollon from Vanderbilt, has challenged this assumption. Their study found that cognitive therapy was as effective and lasted longer than treatment with SSRI drugs in depressed patients. Most of the patients in the study took SSRIs received Paxil. DeRubeis and Hollon recommend that the American Psychiatric Association revise its treatment guidelines.
A study published in the New England Journal of Medicine in 2008 showed that there were several negative studies showing that antidepressants are not significantly successful in treating depression, but that these studies were either usually not published in the U.S. or were published with misleading results. Because this information has been withheld from doctors and the public, they have been unable to make informed choices about whether antidepressants like Paxil are worth the many risks.
If you’re taking Paxil, you may want to consult with your health care provider about alternative therapies. If you’re pregnant or considering becoming pregnant, consult with your health care provider immediately about possible birth defects. If you or a family member has been injured from using Paxil, you may be entitled to damages. See Paxil Attorney and Lawyer – How to Hire for more information on finding a qualified Paxil attorney to evaluate your case.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
To find out more about the FDA warning, see Paxil Side Effects and Risks
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease

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Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease

Antidepressant drugs have received a lot of scrutiny in recent years because of the large number of life-threatening and serious side effects they produce. Studies have shown that the antidepressant Paxil, manufactured by the pharmaceutical giant GlaxoSmithKline, is more likely to produce deadly side effects than other SSRI (selective serotonin reuptake inhibitor) drugs. See Paxil Information and Warnings for more information about Paxil’s safety.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Paxil produces a variety of side effects, all of them serious and several deadly.
Paxil is the only SSRI that carries an FDA warning for birth defects, and Paxil has been particularly linked to heart birth defects. Like other SSRI antidepressants, Paxil has also been linked to abdominal wall and brain birth defects in infants. The most recent side effect discovery concerns yet another form of birth defect. Infants born to mothers taking SSRIs in the last half of pregnancy are 6 times more likely to have persistent pulmonary hypertension (PPHN). Infants with this disorder are unable to get enough oxygen and require intensive care. Usually 10 to 20 percent die soon after birth and some survivors suffer from deafness and neurological problems.
Paxil and other SSRI drugs cause problems to babies whose mothers took the drugs during pregnancy, even if they are born without defects. These newborns often suffer withdrawal symptoms including:
Seizures
Tremors
Jitters
Gastrointestinal problems
Loss of appetite
Sleep disturbance
Additional studies have linked SSRIs with premature births and stillbirths. The long-term effects of fetal exposure to SSRI drugs like Paxil have not been tested and won’t be known for several years.
Paxil has also been linked to increased risk for:
Suicidal thoughts
Suicide attempts
Violent behavior
Aggression
Agitation
Worsening emotional states
Anxiety
Sexual dysfunction
Dizziness
Drowsiness
Gastrointestinal complications
An estimated 50 to 75 percent of patients who stop taking Paxil suffer withdrawal symptoms, which might include (and increase) suicidal thoughts and attempts. Other withdrawal symptoms include:
Electric “zaps” in the brain
Dizziness and vertigo
Nightmares
Sleep disturbance
Crying spells
Tremors
Agitation and irritability
Confusion
Difficulty concentrating and remembering
Changes in gait and coordination
Lethargy and fatigue
Weakness
Nausea and vomiting
High fever
Flu-like symptoms
Diarrhea
Another Paxil side effect has surprised researchers, because at this time it cannot be explained. SSRIs have also been found in a Duke University study to increase the risk of death in patients with coronary artery disease by 55 percent.
Recent studies have revealed another surprise. SSRI use has been linked to loss of bone density and bone in elderly men and women.
If you or a family member have suffered injury for Paxil side effects, you might be able to receive damages. See Paxil Attorney and Lawyer – How to Hire to find an attorney to evaluate your case and your assess your legal options.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney.
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
To find out more about the FDA warning, see Paxil Side Effects and Risks
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
To learn more about Paxil attorneys and how to find one, see Hiring a Paxil Attorney and Lawyer
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Indiana Judge Rules Preemption Not a Factor in Paxil Case

Preemption Not Factor In Paxil Case Drug Toxic Chemicals

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Indiana Judge Rules Preemption Not a Factor in Paxil Case

A federal judge in Indiana has reversed his prior ruling that the family members of a Paxil patient who committed suicide were preempted from suing SmithKline Beecham, the manufacturer of the drug.
The underlying case
The underlying case involves a 55 year old Indiana Catholic priest who committed suicide by shooting himself in the head after he began taking the anti-depressant drug Paxil for 22 days in 2000. The sister of the priest brought a lawsuit against SmithKline Beecham, now GlaxoSmithKline, alleging that her brother’s Paxil use caused him to commit suicide.
U.S. District Court Judge David Hamilton originally dismissed the case based on preemption – which states that a plaintiff cannot bring a claim against a drug manufacturer when the U.S. Food and Drug Administration (FDA) was ultimately responsible for approving the drug’s use in the marketplace. However, Hamilton reversed his own decision and allowed the case to move forward. In his opinion, he explained that he originally “failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.”
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
What the case means
This case comes on the heels of a similar case to be decided by the U.S. Supreme Court this fall. In that case, Wyeth v. Levine, a Vermont woman lost her arm after taking Wyeth Pharmaceutical’s drug, Phenergan. She sued Wyeth in a case that ended up in the Vermont Supreme Court, which ultimately upheld a $6 million judgment in her favor. She alleged that the pharmaceutical giant had not established an adequate warning – even though it complied with the FDA’s requirements.
The ruling in the Indiana case lends further credence to the theory that pharmaceutical companies should be held liable for their products regardless of the FDA’s involvement. However, others – such as Bush Administration – disagree and believe that the FDA, and not pharmaceutical companies, should be responsible for drug safety. Unfortunately, patients cannot sue the FDA when it errs.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Hiring A Paxil Attorney and Lawyer – How to Hire

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Hiring A Paxil Attorney and Lawyer – How to Hire

If you or a family member has suffered injury from one or more of the many Paxil side effects, you may be entitled to receive compensation for those injuries. You will want to have your Paxil lawsuit evaluated as soon as possible, because your state’s law limits the time you have to file this litigation. It is important to get your case to an experienced Paxil attorney before the deadline. Your qualified Paxil lawyer can help you file your case on time and make procedural decisions, such as who to name as defendants and the best and most favorable court to file your Paxil lawsuit.
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Pharmaceutical litigation is very complicated and specialized and not the kind of litigation that you would want to handle on your own or where you would want to be represented by an inexperienced attorney. You are up against the power and resources of expert and very competent attorneys who regularly represent large pharmaceutical companies. Where the stakes are high, the most prudent course is to consult with an attorney, even to negotiate your case.
Finding a good specialist is not always easy. You might try getting recommendations from friends or attorney you know. If that doesn’t work, a good place to start looking is AttorneyPages.com, where you’ll find listings for drug liability specialists in your area, or post your case to the free Case Evaluation Form. After posting your case, an experienced law firm that handles Paxil and similar cases will contact you for a free case evaluation, without any obligation.
Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:
For more information about Paxil, see Drug Overview: Paxil Side Effects and Claims
For more information about Paxil side effects, see Paxil Side Effects – Suicide, Birth Defects & Death from Coronary Artery Disease
To find out more about the FDA warning, see Paxil Side Effects and Risks
For more information about Paxil updates, see Paxil Information and Warnings
If you would like to learn more about Paxil lawsuits, see Paxil Lawsuits, Litigation & Lawyers
Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Ortho Evra Lawsuit – What Is It?

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Ortho Evra Lawsuit – What Is It?

Ortho Evra is a contraceptive patch used by approximately 4 million women since 2002, when it first went on sale. The patch contains estrogen at levels that are 60% higher than the pill and, as Ortho McNeil has itself disclosed, this higher level of estrogen poses a greater risk for blood clots and other serious side effects than previously disclosed to women who use it. Blood clots are an accepted risk of birth control pills because estrogen is a known blood coagulant. However, while Ortho McNeil maintains that the patch is as safe as the pill, FDA records show that before the patch was approved for release, the FDA had already noted that incidences of non-fatal blood clots caused by the patch were three times higher than that of the pill.

Suffered harm from Ortho Evra? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots, and possible strokes in the past two years. Dozens more were allegedly affected by the patch, but survived according to 16,000 drug reports filed with the FDA. On November 11, 2005, the FDA announced approval for updated labeling of the Ortho Evra contraceptive patch product. The new labels warns doctors and patients that the patch contains more estrogen than most birth control pills. This warning is important because higher levels of estrogen mean higher levels of risk. The FDA is, at this time, unwilling to ban the product.

Several lawsuits have been filed by families of women who died of or suffered from blood clots while using the patch. The family of a 14-year-old girl who died claim that she was the youngest victim of the patch. A suit by 10 women was filed in 2005, and in 2006 a suit by more than 40 women who claimed hundreds of other suits was filed.

Suffered harm from Ortho Evra? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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What about family gifts?

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What about family gifts?

Small customary gifts to family members are not voidable preferences. “Small” means less than $200 in aggregate during the past year.

Example: you give your daughter an Aston Martin for her birthday. If it’s a real one worth $250,000, it’s avoidable as a fraudulent transfer. If it’s a Corgi toy costing $25, it’s not.

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Duragesic Patch Side Effects – Drug Overdose

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Duragesic Patch Side Effects – Drug Overdose

The Duragesic Patch, manufactured by Janssen Pharmaceutical Products, and the generic fentanyl transdermal skin patch manufactured by Mylan Laboratories and Actavis Inc., are drug delivery patches that administer doses of the potent narcotic fentanyl through the skin. The FDA (Food and Drug Administration) issued a Public Advisory Warning in July 2005 announcing an investigation into the safety of pain patches after 120 deaths were linked to fentanyl patch use.

Suffered harm from Duragesic Pain Patch? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

Fentanyl is a narcotic drug, said to be up to 100 times as strong as morphine, and an overdose can cause death. The symptoms of a fentanyl overdose include:

Trouble breathing or shallow breathing

Loss of consciousness or coma

Seizures

Cold and clammy skin

Small pupils

Tiredness

Extreme sleepiness or sedation

Confusion

Inability to function normally

Faintness

Dizziness

Overdoses of fentanyl that are not fatal can cause damage to the cardiovascular system (bradycardia) and to the central nervous system. Continued exposure to high doses can lead to dependency and narcotic addiction.

If you or a family member have been prescribed a Duragesic or generic pain patch, you should consult with your health care provider about how to avoid overdoses and be very careful not to use damaged patches or old patches that might have been on the recall list for leaking patches.
In 2007 the FDA issued an additional alert about fentanyl patches, giving the following advice: :

The fentanyl patch should only be used by patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines.

Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose.

Patients prescribed the fentanyl patch should tell their doctor about all the medicines that they take to avoid dangerous interactions.

Patients and their caregivers should be told how to use the fentanyl patch.

Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death.

If you use fentanyl patches take them out of the package with protective gloves on and examine them carefully for leaks, flaws, or variations in size. If you have any doubts about a patch, do not use it.

If you or a loved one have been injured or a family member has died after using a Duragesic Patch or generic pain patch, you may be able to recover damages. See Hiring a Duragesic Patch Attorney for information on finding a Duragesic Patch lawyer who can evaluate your case.

Check out the following articles for more information about Duragesic Patch, filing a Duragesic Patch lawsuit and finding a Duragesic Patch attorney.

For more information about Duragesic Patch, see Drug Overview: Duragesic Patch Side Effects and Claims

For more information about Duragesic Patch updates, see Duragesic Patch Information and Warnings

To find out more about the FDA warning, see Duragesic Patch Side Effects and Risks

If you would like to learn more about Duragesic Patch lawsuits, see Duragesic Patch Lawsuits, Litigation & Lawyers

To learn more about Duragesic Patch attorneys and how to find one, see Hiring a Duragesic Patch Attorney and Lawyer

Suffered harm from Duragesic Pain Patch? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Florida Duragesic Pain Patch Lawsuit – $13 Million Award

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Florida Duragesic Pain Patch Lawsuit – $13 Million Award

A Florida jury awarded a family $13 million after a 34-year old mother of five died from an overdose of painkillers that were delivered by a fentanyl transdermal system patch marketed as Duragesic and manufactured by Johnson & Johnson subsidiaries Janssen Pharmaceutica Products and Alza.
A dangerous drug
According to news reports, Susan Hodgemire, a 34-year old mother of five and an Army military policewoman, had back surgery and was given pain medications afterwards. Some of those medications were delivered through the Duragesic pain patch manufactured by Janssen Pharmaceutica Products and Alza – both subsidiaries of pharmaceutical giant Johnson & Johnson. The patch contained fentanyl, which is an opioid pain medication. She subsequently died from a drug overdose.
Her family sued the drug manufacturers for not warning patients about the potential dangers of the patches and her physician’s assistant for giving improper medical advice. A Florida jury found that the drug manufacturers were 80% responsible for her death, that the physician’s assistant was 20% responsible and awarded her family $13 million in damages.
FDA took action in 2007
The U.S. Food and Drug Administration (FDA) had been investigating pain patches manufactured by several drug makers including Mylan Laboratories since 2005 after receiving reports of 120 deaths that were linked to the patches. At that time, Johnson & Johnson recalled some of its patches due to leaks. In 2007, the FDA issued a safety warning to doctors about the potential risks of using the patch.
Plaintiffs winning lawsuits
According to an article from Bloomberg Johnson & Johnson is 0 for 3 when it comes to winning products liability lawsuits brought by plaintiffs injured by its pain patches. So far, juries in Texas and Florida have awarded millions of dollars in damages in two other lawsuits. Johnson & Johnson’s pain patches are one of its best selling products and generated over a billion dollars in sales in 2007.
If you or a loved one has been injured due to a pain patch, contact an experienced Duragesic patch attorney to discuss your situation. Consultations are free, without obligation and are strictly confidential. To speak with a qualified lawyer, please click here. We may be able to help.

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Jury Awards $16.6 M in Fourth Wrongful Death Duragesic Patch Lawsuit

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Jury Awards $16.6 M in Fourth Wrongful Death Duragesic Patch Lawsuit

An Illinois jury has awarded the family of a 38-year old wife and mother of three nearly $16.6 million in the fourth wrongful death lawsuit against Johnson & Johnson and its subsidiaries over its Duragesic pain patches.
The latest verdict
The latest verdict for $16.56 million was entered against Johnson & Johnson’s subsidiaries Pharmaceutica Inc. and the ALZO Corporation who manufacturer Duragesic fentanyl pain patches. The patches contain fentanyl gel which is 100 times stronger than morphine. According to news reports, the wrongful death lawsuit was filed by the family of Janice DiCosolo, a 38-year old wife and mother of three.
DiCosolo was prescribed the patch in 2004 to alleviate pain from a neurological condition, but died of an overdose. Her family sued the manufacturers, Johnson & Johnson subsidiaries Janssen Pharmaceutica Inc and the ALZO Corporation, for wrongful death and alleged that the patches were defective. A Chicago jury awarded them $16.56 million. This is the fourth verdict against Duragesic pain patch manufacturers in the past two years.
Previous verdicts The first two wrongful death verdicts came in 2006 and 2007 for a combined total of $6.3 million. The third verdict came only a few weeks ago when a Florida jury awarded the family of Susan Hodgemire, a 34-year old mother of five and an Army military policewoman, $13.3 million after she died from an overdose of a fentanyl pain patch which was prescribed after she underwent back surgery.
Other lawsuits pending
Legal experts say that the manufacturers face another 60 product liability / wrongful death lawsuits concerning the patches and the U.S. Food and Drug Administration (FDA) has issued a warning letter to doctors about the product’s dangers. However, many believe that the pharmaceutical industry has convinced doctors that patches are more beneficial than harmful and that it all comes down to money in the end. Whether or not that’s true, more and more overdoses are being reported and the awards in wrongful death and product liability lawsuits continue to escalate.
If you’ve been injured due to a pain patch, contact an attorney to discuss your situation. Consultations are free, without obligation and are strictly confidential. To speak with an experienced products liability lawyer, please click here. We may be able to help.

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Johnson & Johnson Recalls Duragesic Pain Patches

Johnson Johnson Recalls Duragesic Patches Drug Toxic Chemicals

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Johnson & Johnson Recalls Duragesic Pain Patches

Johnson & Johnson issued a voluntary recall all lots of its 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold in the US by PriCara and all 25 mcg/hr fentanyl patches sold in the US by Sandoz Inc. The company reported that the patches may have a cut edge that could leak fentanyl gel and cause serious injury.
Details of the recall
According to a Johnson & Johnson press release – PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and a member of the Johnson & Johnson family of companies – the following products are being recalled:
All lots of 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold by PriCara in the United States
All 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States
All of the recalled patches were manufactured by the ALZA Corporation, an affiliate of PriCara, and have expiration dates on or before December 2009. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled. Patches with 12.5, 50, 75 and 100 mcg/hr strengths aren’t affected.
Safety warnings
The patches may have a cut along one side of the drug reservoir within the patch that may result in the possible release of fentanyl gel and may expose patients or caregivers to that gel – an opioid analgesic with a potency approximately 80 times that of morphine or greater. Patches that are cut or damaged should not be used as serious injury could occur. According to the company:
Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
Additional information
Johnson & Johnson provided the following consumer information:
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.

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