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Effexor Birth Defects Lawsuits

The antidepressant venlafaxine—sold under the brand name Effexor but also less commonly as Efexor, Alventa, Argofan, and Trevilor—has been identified as a potential cause of life-threatening birth defects, such as cleft lip, clubbed foot, and serious heart defects, and other side effects.

What Is Effexor? When Is It Prescribed?

Effexor is a brand name for the drug venlafaxine. Made and sold by American pharmaceutical company Wyeth, now a Pfizer subsidiary, this prescription medication is used to treat major depression, obsessive-compulsive disorder, panic disorder, premenstrual dysphroic disorder, and anxiety disorders. Wyeth received approval from the U.S. Food and Drug Administration (FDA) to market venlafaxine as Effexor in 1993, and the patent expired in 2006. In 2007, it was the sixth most commonly prescribed antidepressant in the U.S., totaling 17.2 million prescriptions in 2007. Venlafaxine comes in oral tablets with dosages ranging from 12.5mg to 150mg.

Effexor is a member of the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) class of antidepressants. Like Selective Serotonin Reuptake Inhibitors (SSRIs), SNRIs prevent receptors in the human brain from absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. Unlike SSRIs, SNRIs also prevent re-absorption of norepinephrine (also called noradrenaline), which regulates stress levels. SNRIs take a few weeks to affect users, and they can cause many side-effects in the process, particularly nausea, somnolence, and sexual side-effects. It does not cause significant weight gain like SSRIs, though.

As the adverse effects of Effexor have become better known, the FDA has required more stringent product warnings and prescription requirements, culminating with an October 2004 “black box” Effexor warning.

Meanwhile, concerns that antidepressants, including Effexor, are less effective than advertised are growing. For example, the New York Times reported that negative studies on their efficacy are often suppressed. The FDA also sent Wyeth a warning letter in 2007 over an Effexor advertisement in a medical journal that over-hyped its beneficial effects while downplaying the drug’s side effects.

Effexor Might Cause Birth Defects

Effexor reportedly has the potential to cause numerous birth defects, injuries, and other complications, usually when used during the first trimester, including the following:

  • Premature birth
  • Miscarriage. An article in the Canadian Medical Association Journal reported a study on antidepressants showing that 5.5% of the pregnant women on them suffered spontaneous abortions as opposed to a non-antidepressant-using control group’s 2.7%.
  • Withdrawal symptoms, such as: breathing difficulties, turning blue, low blood sugar, jaundice, changing body temperatures, feeding problems, convulsions, vomiting, floppiness, stiffness, irritability, jitteriness, abnormal crying, and tremors.
  • Clubbed foot. Called “Congenital Talipes Equinovarus” by medical professionals, one or both feet of children born with this condition are turned inward at the ankle. Most cases are easily treated non-surgically.
  • Cleft lip or palate. A cleft lip occurs when the tissue forming a child’s upper lip fails to fuse properly. A cleft palate means the bones comprising the roof of a child’s mouth did not properly join, connecting the mouth to the nasal cavity. Both can be resolved surgically, though a cleft palate can sometimes be fixed by placing a prosthetic device in the palate.
  • Delayed development. A February 2010 study published in Pediatrics determined that on average, children born to women who used antidepressants began sitting upright 16 days later than average, and began walking one month later as well.
  • Persistent Pulmonary Hypertension (PPHN). An article in the February 2006 issue of the New England Journal of Medicine demonstrated that babies born to women using antidepressants past their 20th week of pregnancy were six times more likely to develop PPHN than women who were not using an antidepressant. PPHN is a life-threatening condition in which high pressure in blood vessels in children’s lungs results in insufficiently oxygenated blood.
  • Gastroschisis. Usually a genetic hernia, gastroschisisis a defect on one side of the umbilical cord that allows a portion of the infant’s intestines to protrude out of the body. It is often undetectable before birth, but surgeons can repair the damage by either pushing the intestines back into the body or by stitching a mesh around the protrusion.
  • Enlarged heart is condition in which the heart is both too large and weak to efficiently pump blood through the body.
  • Septal heart defects. The most common heart defect associated with antidepressants, the wall (septum) separating the left side of the heart from its right is malformed. Sometimes surgery is necessary to correct the damage. The September 2009 edition of the British Medical Journal contained an article showing that women on antidepressants during their first trimesters were twice as likely to give birth to children with septal defects as normal. Taking more than one antidepressant during the first trimester quadrupled the probability of a septal heart defect versus women who did not take the drugs.
  • Left outflow tract heart defects. This defect refers to a child born with a narrow aorta, the body’s primary artery, and it requires surgical correction.
  • Macrocephaly is a condition in which the child’s head is abnormally large, measured at two standard deviations above the average in head circumference. Macrocephaly correlates to infections, internal bleeding in the skull, cysts on the brain, and other defects.
  • Craniosynostosis is a condition in which portions of the child’s skull fuse prematurely, which causes the skull plates to grow in different directions to accommodate the expanding brain. If the skull fails to grow sufficiently, the intracranial pressure on the child’s brain can lead to visual and cognitive impairments.
  • Neural tube defects. A neural tube defect consists of an opening in a child’s spinal cord or brain caused by a failure of specialized nerve cells to fuse properly. The several types of defects are horrific and in some instances the child is born without significant portions of the skull and brain. In many circumstances the child does not survive more than a few hours after birth.
  • Spina bifida. A more common, specific kind of neural tube defect. Spina bifida is not as fatal as the ones mentioned above because it affects the lower spinal column. In some instances, the spinal cord protrudes through the gap between the unfused bones, and in others a fluid-filled sac surrounds the spinal cord. Sometimes surgeons can close the opening in patients’ backs.

Other Effexor Side Effects

Medical experts have also identified Effexor as a potential cause of two other significant side effects: increased thoughts of suicide; and complications for those with pre-existing heart conditions.

As early as 1990, people reported that antidepressants caused increased suicidal thoughts and behaviors. The FDA considered the issue, but it did nothing more. It became clear that antidepressants could adversely affect children and teenagers, making them hostile, irrational, violent, or suicidal. In 2006, the FDA analyzed the results of 372 studies of antidepressants, finding that even young adults (ages 18-25) were also afflicted with behavioral changes. As a result, the FDA ordered antidepressant manufacturers, including Wyeth for Effexor, to include added warnings to consumers. However, a study, which included venlafaxine users, published in the Feb. 6, 2012 edition of the medical journal, Archives of General Psychology, contradicted earlier findings that connected SSRI use to increased suicidal activity in youths. Although, the researchers did not detect a decrease in suicidal thoughts and behaviors compared to adults and geriatric patients.

Recently, a study conducted at Duke University concluded that those with coronary artery disease faced greater risk of death due to Effexor use. The researchers could not determine the reasons for the connection, but they found the connection statistically significant. For those with heart disease, in an average three years of follow-up, 21.4 percent of the participants still on antidepressants died as opposed to 12.5 percent who were not on antidepressants.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group do everything they can to streamline the process of helping you to obtain compensation.

If you have taken Effexor and believe it harmed you, contact RLG today.

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rlg Previous Comments

  1. Guest
    on September 6, 2012 at 6:45 pm

    My brother was prescribed Effexor-xl at age 20 for mild depression, immediately began suffering acute insomnia, suicidal ideation and self-harmed. Was sent home from Belgium (had been serving a mission for the Mormon church) he was not warned about sudden withdrawal and abruptly ceased medication. Within a few days was suffering delusions etc and was sectioned and pumped full of other drugs for his sudden 'psychosis'. Was never given info or choices, sectioned a couple of times trying to come off other meds cold turkey. It took me ten years to figure out he was not insane and the Effexor had caused a domino effect in doctors diagnosing him with various mental illnesses and subsequent drugs causing psychotic symptoms too. He was robbed of ten years of life, lived like a filthy zombie and has gained approx seven stone in weight. He is covered in scars on his arms from the self-harm and is unemployable to all intents and purposes due to the ten year gap in his employment history, how do you explain a past like that to a future employer? He has all but missed his chances of finding a partner, would you date a 20 stone bloke covered in scars with a history of 'mental illness'?? I was practically his wet nurse for ten years and the stress for me has been enormous, details too long to go into at present but it cost my education and almost cost my marriage. Effexor destroyed my life, and my brothers, I am by no means exaggerating when I say that! He was just a twenty year old kid with a bit of depression and can't believe he's now 31 alone, having lost the best years of his life with practically no prospects for future employment or relationships.

  2. Guest
    on August 16, 2012 at 10:41 pm

    I am having horrible hot flashes one minute then cold the next. I am very agitated and get very frustrated with my family. My mind is cloudy, I want to sleep but can't for the body temps changing so often. Have crazy dreams. I have a hard time staying awake in the day. Can't focus, ramble a lot. Very emotional can cry very easily. Want to just curl up in a ball and let life go by.

  3. Guest
    on June 18, 2012 at 10:44 pm

    I was taking effexor. I too would have moments when I couldn't quit crying..trouble sleeping and also breathing problems. I lost my job because I wasn't able to focus or stop the thoughts of suicide. I've quit taking them months ago and I'm still having breathing problems and trouble sleeping no more than 4hrs or less. Since I quit taking them, I'm less depressed but I'm still having breathing problems. I wish I would of never been prescribed them because now I'm worried about my health.

  4. Guest
    on June 17, 2012 at 11:37 pm

    I went to my doctor for issues with my menstrual cycle. She felt I needed effexor. After a few months of increased anxiety I'd never had it was suggested I try a different med. I've never had depression or anxiety. After telling her I didn't need this and it was making me mental and suicidal she said to stop taking it. I read different. I've been weaning off. Almost lost my job. Contemplated killing myself. Can't track thoughts or days. The brain Zaps are insane. I vomit randomly and my boyfriend of 5 years wants to leave me. More to it but here are the basics. I'm not a lowlife drug seeker. I initially just wanted birth control and am now at the point of wondering if anyone would miss me.

  5. Guest
    on May 3, 2012 at 9:14 pm

    I have several side effects. The worst was withdrawal, behavior, irritability, delusions, and thoughts of suicide. I have been in therapy for several years. Also my breathing is difficult and I am being treated.

  6. Guest
    on March 19, 2012 at 2:54 pm

    I was put on Effexor HCL ER 3years ago. I can't tell you when these symptoms really started but I know in the past year I have been experiencing bad side effects. I had to go to the DMV to get a placard because I can no longer walk very far at all. I have stopped driving due to confusion and poor memory. I am one two other psych medications and I'm coming off of Klonopin after a three year use. Before that other anti anxiety pills were prescribed. In total, I have been on anti anxiety medication for 7 years. I have been on psych medication for a total of 7 years and still taking... I cannot explain the pain that goes through my entire body and brain. I am on 150 mg's a day along with 150 mg's of Wellbutrin (generic) and 150 mg's of Lamictal. My sense of smell, sight, and hearing have been effected as well. I have huge suicidal thoughts and have been known to cut myself. The "unpleasant" side effect warning is NOT nearly what I am going through. I am going through hell. I live on Boost now with very very little food intake. Being that I am a psych patient and on medication, I can't remember or concentrate. I am like a walking nerve bomb. Look at me or talk to me wrong and I explode... I have not had intimate relations with my spouse in quite some time!!!

  7. Guest
    on February 16, 2012 at 11:04 pm

    Bleeding for weeks, obgyne scheduled for DNC. If I went through with the surgery, I could have died. Severe withdrawals from trying to get off. Once I tapered off, bleeding stopped.

  8. Guest
    on February 7, 2012 at 9:08 pm

    I was put on Effexor CR 150 mg 2years ago. I was told by my doctor it was a last resort because none of my other antidepressant drugs that I tried had worked. I have since tried to come off the drug with horrible side effects such as increased thoughts of suicide, anxiety, shakes, seizures, crying episodes, a serious feeling of unease. These side effects were so bad that I felt if I did not take this Med I would surely die. My doctor advised me that trying to get off this Med is extremely difficult and, because of my high blood pressure, is not a good idea and the fact that she thought the Med was doing its job so leave it be. I have since started seeing a new doctor who stated I will never be able to stop taking this drug due to the seriousness of the side effects I had experienced. This is a very dangerous drug, a very bad drug to give someone who is already suffering enough and doesn't want to suffer more.

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