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Effexor Side Effects May Lead To Birth & Heart Defects Lawsuits

Effexor Side Effects include: Birth Defects, Heart Defects, Potential Lawsuits | Cleft Lip & Palate, Neural Tube Defects, Clubfoot

The personal injury law firm, Parker Waichman LLP is investigating incidents of birth defects associated with Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants. Studies have indicated that mothers who take such drugs - especially in the first three months of pregnancy - may be at a higher risk of having a child with a birth defect. Some of the birth defects that may be associated with SSRIs include heart defects such as septal defects, neural tube defects such as spina bifida; clubfoot; cleft lip and cleft palate; and limb defects. In 2006, the FDA issued a warning regarding a possible association between PPHN and SSRIs in the second half of pregnancy. The year prior, a Danish study showed that infants exposed to SSRIs during the first trimester of pregnancy had a 60% higher probability of developing congenital heart defects when compared with infants whose mothers did not take the drugs.

If you have taken Effexor, and have given birth to a child with a birth defect the defective drug may be to blame. Below is a list of potential birth defects that may be linked to the use of Effexor:

  • Congenital heart lesions & anomalies
  • Down's syndrome
  • Undescended testes in males
  • Blindness
  • Spina bifida
  • Hernia
  • Malformations
  • Clubfoot (one or both feet turn downward and inward)
  • Septal defects; Cleft lip and/or cleft palate

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

Suicidal Behavior Linked to Antidepressant Drug, Effexor Usage

On October 25, 2006 the FDA advised doctors to prescribe the popular antidepressant Effexor in the smallest possible amounts to decrease the risk of overdose. The FDA in conjunction with Wyeth, the manufacturer of Effexor had reports of overdoses occurring in some patients, mostly in combination with alcohol or other drugs, the agency said in a statement. Wyeth said in a letter it sent to doctors and health care providers that the reported overdoses resulted in death or symptoms such as rapid heartbeat, coma, seizures, vomiting and vertigo. Additionally the letter did not reveal how many overdose cases had been reported. The letter urged doctors to report any adverse reactions to Effexor to the company or to the FDA.

The FDA approved Effexor (Generic: Venlafaxine), manufactured by Wyeth, on July 17, 2000. Effexor, which is still on the market, has been linked with suicide, suicidal ideation, suicidal behavior and suicide attempts. Effexor is a SNRI antidepressant (serotonin norepinephrine reuptake inhibitor) and is used to treat depression and associated anxiety symptoms.

On September 16, 2004, the FDA acknowledged that a small number of children and teenagers who use Effexor become suicidal or have suicidal thoughts. As a result, a scientific advisory committee voted 15-8 recommending to the FDA that it put a ″black box″ warning on the labels for the antidepressants about the suicide risk for the youths who take them.

In August 2003, Wyeth issued a warning to doctors about clinical trial evidence linking Effexor to suicidal thoughts in young patients, and the company added that warning to the drug's label. In what is known as a "Dear Doctor" letter, Madison-based Wyeth told health professionals that clinical studies of the long-acting version, Effexor XR, found a higher incidence in children of "hostility and suicide-related adverse events, such as suicidal idealization and self-harm." No children in the tests committed suicide. "You should be alert to signs of suicidal idealization in children and adolescent patients prescribed Effexor or Effexor XR (and) reassess the benefit-risk balance," the Wyeth letter states

The caution comes after U.S. and British regulators said no one under 18 should take GlaxoSmithKline's popular antidepressant Paxil because it could increase a child's risk of suicide attempts. Pediatric patients already taking Paxil were told to stop use gradually, under a doctor's supervision.

Effexor generated $2.1 billion in sales in 2004, making it Wyeth's biggest selling drug.

In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.

During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.

Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

Legal Help For Victims Affected By Effexor

If you or a loved one took Effexor or other antidepressant drugs and suffered any of the side effects mentioned here, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).

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Elderly Treated with SSRI Antidepressants Suffer More Bad Outcomes, Study Says

Aug 3, 2011 | Parker Waichman LLP
A new study out of Britain has found that selective serotonin reuptake inhibitor (SSRI) antidepressants may pose more risks to elderly patients compared to older drugs called tricyclic antidepressants.  SSRI antidepressants, which include drugs such as Prozac and Effexor, are widely prescribed to older patients, but surprisingly, few studies have been conducted to assess their safety in this population.For this study, which was published in the British Medical Journal, a team of...

Doctor Accused of Falsifying Drug Studies Pleads Guilty

Feb 23, 2010 | Parker Waichman LLP
Dr. Scott S. Reuben, former chief of acute pain at the Bay State Hospital in Springfield, Massachusetts, has pleaded guilty to one count of health care fraud. As we’ve reported previously, Reuben was charged in federal court last month with falsifying studies involving the post-surgical benefits of drugs like Vioxx, Bextra, Celebrex, Effexor and Lyrica. According to the Associated Press, federal prosecutors in Massachusetts had alleged that Reuben sought and received research grants from...

Baystate Medical Center Subpoenaed Over Fake Drug Studies

Apr 8, 2009 | Parker Waichman LLP
The Baystate Medical Center has received a subpoena as part of a federal investigation into a doctor there who falsified 21 drug studies.  According to The Wall Street Journal, the U.S. Attorneys office in Boston is seeking financial records related to the work of Dr. Scott S. Reuben.  As we reported last month, medical journals have been asked to retract studies involving Vioxx, Celebrex, Lyrica and other drugs.  All of the studies were published between 1996 and 2008. According...

Researcher Faked Data for 21 Studies Involving Vioxx, Celebrex and Other Drugs

Mar 11, 2009 | Parker Waichman LLP
Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs.  According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.In addition to Vioxx and Celebrex, some of the 21 studies involved the fibromyalgia drug Lyrica and the antidepressant Effexor XR.   Reuben's...

Antidepressants Linked to Sudden Cardiac Death in Women

Mar 11, 2009 | Parker Waichman LLP
A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD).  HealthDay News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology."We suspect that their use is a marker for people with worse depression," explained the study’s lead author Dr. William Whang, an...

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