Effexor: Health Risks and Legal Action

Effexor (venlafaxine) is an antidepressant drug. Effexor XR (venlafaxine hydrochloride) is the extended-release version of the drug, designed for once-daily dosing.

Patients use Effexor for different mental health disorders, including:

• Depression, including major depressive disorder
• Generalized anxiety disorder (GAD)
• Social anxiety disorder (SAD)

Wyeth Pharmaceuticals, Inc. originally manufactured the antidepressant medication when the Food and Drug Administration (FDA) approved it in 1993. Pfizer later bought the company.

Pfizer discontinued Effexor in 2006, but the extended-release version is still available. The pharmaceutical company retained the extended-release medication because patients only have to take it once daily. There are also fewer side effects.

Before Pfizer took Effexor off the market, many patients complained of severe adverse side effects. The same is true of the current medication still available, Effexor XR.

This article discusses how the medication works as an antidepressant. It also describes the side effects, potential health hazards, and lawsuits associated with the drug.

If you or a loved one has suffered harm from taking Effexor, consider reaching out to a product liability attorney near you. An attorney can offer targeted legal advice and determine if you have a valid claim. If so, they will advocate for you throughout the legal process.

What Is Effexor and How Does It Work?

Venlafaxine hydrochloride, marketed as Effexor, was a selective serotonin reuptake inhibitor (SSRI). It was just one of many antidepressant drugs.

Many people confuse Effexor and Effexor XR with other antidepressants, including:

• Paxil
• Wellbutrin
• Prozac
• Zoloft
• Fluoxetine
• Cymbalta
• Celexa

These products have separate uses and outcomes and are not merely generic names for the drug.

Effexor XR is venlafaxine hydrochloride in extended-release form. It’s a different formulation of Effexor used to treat depression, generalized anxiety disorder (GAD), and social anxiety disorder (SAD). Companies also sell venlafaxine hydrochloride under that name.

Effexor FDA Safety Alerts

More than ten years after it initially approved Effexor, the FDA issued a drug safety alert in 2006 stating that combining Effexor with other medications can cause a life-threatening condition called serotonin syndrome.

This condition can occur when patients take serotonin and norepinephrine reuptake inhibitors (SNRIs) and medicines used to treat migraines, known as 5-hydroxytryptamine receptor agonists, at the same time.

Signs and symptoms of serotonin syndrome include:

• Restlessness
• Hallucinations
• Loss of coordination
• Fast heartbeat
• Increased body temperature
• Rapid changes in blood pressure
• Overactive reflexes
• Diarrhea
• Nausea
• Vomiting
• Coma

Serotonin syndrome may be more likely to occur when you start taking these drugs or increase their dose.

Effexor and Increased Risk of Suicide

Serotonin syndrome is not the only health risk of Effexor and Effexor XR. Children and teens who took Effexor or Effexor XR were prone to suicidal thoughts.

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their labels to include boxed warnings. It also ordered them to alert healthcare providers of an increased risk of suicidality in children and adolescents.

In response to the FDA advisory, Wyeth (and Pfizer) added a black box warning to the drug’s prescription information.

Other Health Risks of Taking Effexor and Effexor XR

There are severe additional health risks aside from those discussed above. For example, never take Effexor if you take a Monoamine Oxidase Inhibitor (MAOI) or have taken one in the last 14 days.

Taking both an MAOI and Effexor can lead to serious side effects, such as the following:

• High body temperature
• Coma
• Seizures

If you are still taking Effexor XR, see your healthcare provider regularly for check-ups. You should also talk to your obstetrician if you are pregnant or thinking about getting pregnant.

Potential Risks of Congenital Disabilities

There are studies linking Effexor and Effexor XR to certain birth defects and congenital disabilities in children. Children of pregnant women who took Effexor during pregnancy face an increased risk of developing the following:

• Heart defects
• Problems swallowing or breathing
• Cleft palate

One of the most severe health conditions babies of Effexor patients experienced was Persistent Pulmonary Hypertension of the Newborn (PPHN). This causes life-threatening heart issues that can be difficult to diagnose.

Talk to your healthcare professional if you are pregnant, breastfeeding, or planning to breastfeed your baby and are using Effexor XR or another antidepressant. For more information, see FindLaw’s article on Antidepressants and Pregnancy.

Effexor Lawsuit Information

Pharmaceutical companies are legally obligated to ensure their medications are safe for users. The FDA must also approve a drug before the manufacturer sells it to the American public. Drug manufacturers must also inform doctors and patients about any excessive risks their drugs pose, even if the FDA hasn’t yet required a black box warning.

A company that doesn’t disclose such risks may be liable to persons harmed by those drugs under a “failure to warn” theory of liability.

For example, imagine a drug manufacturer knows its drug poses a risk of developing congenital disabilities. It doesn’t warn doctors or expectant mothers of this danger. The courts may order the company to compensate patients for injuries caused by the drug.

Damages may include any or all of the following:

• Medical expenses
• Future medical bills
• Pain and suffering
• Lost wages
• Lost future income
• Emotional distress

The judge may also order the drug manufacturer to pay the plaintiff punitive damages. Punitive damage awards in these cases are few and far between. In such cases, the plaintiff’s attorney must demonstrate that the pharmaceutical company acted recklessly, intentionally, or wantonly.

Effexor: Litigation History

Plaintiffs filed the first Effexor case in 2012 in Pennsylvania. In this case, the plaintiff alleged that her daughter died because of heart defects caused by Effexor.

Later that year, a second Effexor lawsuit was filed in federal court in Pennsylvania by an Illinois couple. The plaintiffs in that suit alleged that their daughter was born with a condition called hypoplastic left heart syndrome and that Effexor was the culprit. The plaintiffs claimed that the syndrome required repeated surgeries and other expensive medical treatment.

In October 2012, a Montana couple whose daughter was also born with congenital heart defects sued Pfizer. The plaintiffs also sued the drugstore chain that filled the prescription, the pharmacist who dispensed Effexor, and the doctor who prescribed it to the expectant mother.

In 2013, the federal courts consolidated nine Effexor birth defect lawsuits for pre-trial proceedings. A single federal judge in Pennsylvania, Judge Cynthia Rufe, oversaw the cases as the parties prepared for trial.

In 2016, the judge dismissed the remaining lawsuits against Pfizer and closed the multi-district litigation (MDL). If you suffered an injury while taking Effexor or Effexor XR, contact a product liability attorney near you to discuss your legal options.

Were You Injured While Taking Effexor? Get Legal Help

If you experienced any serious complications while taking Effexor, including giving birth to a child with congenital disabilities, you may have a legal claim. A lawsuit allows you to pursue damages related to your child’s condition, including compensation for any medical expenses or pain and suffering your child has endured. Consult with an attorney for the best next steps.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases.