**Please note that we are no longer taking these cases**
Potentially Life-Threatening Serotonin Syndrome with Combined Use of SSRIs or SNRIs and Triptan Medications
There is the potential for life-threatening serotonin syndrome (a syndrome of changes in mental status, autonomic instability, neuromuscular abnormalities, and gastrointestinal symptoms) in patients taking 5-hydroxytryptamine receptor agonists (triptans) and selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs) concomitantly.
This information is based on reports of serotonin syndrome occurring in patients treated with triptans and SSRIs/SNRIs, and the biological plausibility of such a reaction in persons receiving two serotonergic medications. The FDA recommends that patients treated concomitantly with a triptan and an SSRI/SNRI be informed of the possibility of serotonin syndrome (which may be more likely to occur when starting or increasing the dose of an SSRI, SNRI, or triptan) and be carefully followed.
Debate Resumes on the Safety Of Depression’s Wonder Drugs
Warnings by drug regulators about the safety of Paxil, one of the world’s most prescribed antidepressants, are reopening seemingly settled questions about a whole class of drugs that also includes Prozac and Zoloft.
Doctors are just beginning to react to the finding — reported first by British drug authorities in June and then endorsed the next week by the Food and Drug Administration — that unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide.
Because the studies also found that Paxil was no more effective than a placebo in treating young people’s depression, the regulators recommended that doctors write no new Paxil prescriptions for patients under 18. Experts say that the suicide risk is highest in the first few weeks young patients are on the drug.
The concern that Paxil and drugs like it could cause suicide had been weighed, and rejected, by regulators a dozen years ago, amid early concerns about the group of antidepressants known as selective serotonin reuptake inhibitors, or S.S.R.I.’s. In the meantime, millions of people have taken the drugs, and many experts say that they have prevented far more suicides by teenagers and children than any reading of the new findings suggests they could have caused.
Almost no one suggests that Prozac, Zoloft, Paxil and their cousins are not safe for the vast majority of adults, although studies have shown them to be only modestly effective.
Still, the warnings have the early critics saying they feel vindicated. Plaintiffs’ lawyers who have uncovered evidence that they say shows drug makers withheld evidence of the S.S.R.I.’s suicide risk from regulators say the warnings give fresh urgency to their claims.
FDA 2006 Data Summary
FDA 2006 Data Summary on SSRI Study
A retrospective case-control study published on February 9, 2006, in the New England Journal of Medicine assessed the risk for persistent pulmonary hypertension of the newborn (PPHN) following exposure to SSRIs during pregnancy. 377 women whose infants were born with PPHN and 836 women whose infants were healthy were enrolled in the study in four United States metropolitan areas between 1998 and 2003.
The study showed that infants born to mothers who took SSRIs after the completion of the 20th week of gestation were 6 times more likely to have PPHN than infants who were not exposed to antidepressants during pregnancy. 14 infants with PPHN and 6 healthy control infants had been exposed to an SSRI after the 20th week of gestation. There were too few cases of PPHN with each individual SSRI to compare risks for PPHN with individual SSRIs. The study did not find an association between exposure to SSRIs during the first 20 weeks of gestation and PPHN.
Exposure to non-SSRI antidepressants did not appear to be associated with an increased risk of PPHN, although the number of infants with exposure to non-SSRI antidepressants was too small to permit a reliable risk estimate or comparison with the risk observed for SSRIs.
In weighing the risks and benefits of treatment with SSRIs and other antidepressants during pregnancy for individual patients, physicians should also note the recent publication of a prospective longitudinal study of 201 pregnant women with a history of major depression in the February 1, 2006, issue of JAMA. In this study, women who discontinued antidepressant medication during pregnancy had a higher risk of relapse of major depression during pregnancy (68%) than women who maintained antidepressant medication throughout pregnancy (26%).
Increased Risk of Neonatal Persistent Pulmonary Hypertension FDA
Alert June 2006
A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births.
Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.
Depakote has been linked to serious birth defects.
The family has been awarded $15 million to cover the child’s medical expenses and loss of future earnings, which were estimated to be between $10.3 – $13.7 million, and $1.8 million. The jury declined to levy punitive damages against Abbott.
Christina Requel, the child’s mother, had been prescribed Depakote while pregnant for a severe bipolar disorder. Her treating physicians said the drug label showed the risk of spina bifida at 1-2% but later learned that the risk is actually 10%. The drug is an anti-epilepsy drug used to treat many conditions.
Attorneys for the family argued that a conscious decision was made by Abbott to hide the true risk to keep the drug profitable. Depakote was the first of the Abbott’s drugs to reach $1 billion in sales.
This is the sixth lawsuit over Depakote. There are currently hundreds of lawsuits filed against Abbott with the majority consolidated in the Southern District of Illinios.
Case number 3:15-cv-00702, Southern District of Illinois
Depakote (divalproex sodium), is an anti-convulsant medication used to treat epilepsy and manic episodes in bipolar disorder. Use of Depakote by pregnant women poses the risk of serious Depakote birth defects in their unborn infants including spinal birth defects, malformations of the hands, mid face and ribs, heart defects and malformations of male genitalia.
The FDA classifies Depakote as a Class D drug because it is known to cause a significant risk of birth defects when taken by pregnant women. Manufactured by Abbott Pharmaceuticals Ltd., the drug has been on the market since 1983. The ingredient in Depakote that is responsible for most of the risk of fetal injury is valproate sodium which is also sold under generic names by several pharmaceutical companies.
NOTE: we are no longer accepting Paxil cases
Paxil is one of the highest selling antidepressant drugs known as a selective serotonin reuptake inhibitors (SSRIs). It was introduced by GlaxoSmithKline (GSK) in 1992 and has been prescribed to millions of pregnant women to control depression. It has been discovered that potentially hundreds of thousands of children may have been born with debilitating and deadly birth defects.
Paxil Defective Drug Lawsuits
2004 – The Food and Drug Administration (FDA) discovered that Paxil potentially caused serious birth defects.
2005 – The FDA issued a Paxilblack box warning regarding the chance of birth defects, the most serious warning they can issue.
2010 – GSK fined $750 million to settle civil and criminal charges that it made and sold adulterated Paxil to Medicaid under violation of the False Claims Act. Estimated cost to the American tax payer totaled $6 Billion.
2011 – Thousands of current and former Paxil patients seek just compensation for birth defects.
The lawsuits allege:
- Paxil causes birth defects.
- GlaxoSmithKline knew about the risk and withheld the information.
- The company failed to provide adequate warnings.
Paxil Birth Defects
Anal Atresia: The child’s anus is either non-existent or placed in the wrong place on the body. Major surgery is required.
Anencephely: Either the child is born without a brain or there is inadequate development to allow the child to survive. There is no treatment.
Cleft Lip or Palate: A lack of adequate tissue forms on the roof of the mouth and upper lip. Beyond the cosmetic problems, this results in the child having serious eating and breathing problems. Surgery is required.
Clubfoot: Clubfoot happens when the baby is born with a foot that is twisted out of shape or position. Treatment is painful to the child, but fixable depending on the severity of the defect. Movement is generally marred for the rest of the child’s life.
Coarctation of the Aorta: The aorta is underdeveloped and narrow. This makes it hard for blood to pass through the artery resulting in inadequate blood flow to the rest of the body. Fixed with a stint, it may lead to future heart health concerns.
Congenital Heart Defects: These are defects in the structure of the heart and may require major surgery or heart transplant.
Craniosynostosis: The head develops in an odd shape. For the brain to grow and to relieve pressure doctors must reshape the skull.
Infant Omphalocele: The abdominal muscles of the baby don’t properly develop leaving them unable to adequately contain the intestines causing the organs to pop out of the belly button. Major surgery and cosmetic reconstruction usually required.
Lung Defects: There are many types of lung defects from blood flow, to deformity, to underdevelopment. These are addressed separately with varying treatments that can be resolved through incubator or surgery. A lifetime of breathing problems may follow.
Patent Ductus Arteriosus: A blood vessel called the ductus arteriosus fails to close normally (“patent” means open). Treatment involves inserting a catheter to drain the blood and waiting to see if it closes later. If it doesn’t, surgery may be required.
Persistent Pulmonary Hypertension of the Newborn (PPHN): The newborn’s circulation has not made the normal transition from fetal circulation to normal newborn circulation. Surgery may be required.
Spina Bifida (Myelomeningocele): During the first month of a pregnancy, spinal nerves and tissues come together to cover the spinal cord. Spina bifida means this process did not happen. It requires surgery and physical therapy.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers or surgical instruments can harm patients when the product is defective in the manufacturing process, design or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
Nationally recognized as a leading plaintiff’s law firm, we handle cases in all 50 states and Puerto Rico.
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