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Injured by Effexor?

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.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk. 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 iEffexor 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 ideation and self-harm." No children in the tests committed suicide. "You should be alert to signs of suicidal ideation 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.

If you or a loved one took Effexor and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.