Effexor Recent News

Effexor is the brand name for venlafaxine. It's an antidepressant that has been on the market for more than 30 years. Wyeth Pharmaceuticals originally manufactured the drug and submitted it to the FDA for approval in 1993.

In October 2009, Pfizer bought Wyeth and has manufactured Effexor ever since.

According to the FDA, Effexor and Effexor-XR (venlafaxine extended-release) treat the following mental health conditions:

• Depression (major depressive disorder)
• Generalized anxiety disorder (GAD)
• Social anxiety disorder
• Panic disorder

Effexor and Effexor-XR belong to a specific class of drugs — selective serotonin reuptake inhibitors (serotonin-norepinephrine reuptake inhibitors). All SNRIs pose health risks and carry adverse side effects such as suicidal thoughts and high blood pressure.

Over the years, the drugmaker has submitted Effexor to the FDA for various uses. Experts and healthcare professionals have questioned Effexor's safety. The drug came under attack due to patients' increased risk of serotonin syndrome and other severe health conditions.

Pfizer discontinued Effexor in 2006. But Effexor-XR (extended-release) is still available. The drugmaker markets this drug as venlafaxine hydrochloride (HCL), and doctors use it to treat the same disorders as the original Effexor.

We will discuss these in depth here. We will also discuss the history of Effexor and the drug's risks and side effects.

Medications Similar to Effexor

Effexor is no longer on the market. When it was available, many patients confused it with other antidepressant medications.

Drugs that are like Effexor and Effexor-XR include:

• Paxil (Paroxetine HCL)
• Prozac (Fluoxetine)
• Wellbutrin (Buproprion HCL)
• Zoloft (Sertraline)
• Celexa (Citalopram)
• Cymbalta (Duloxetine)

Don't confuse any of these medications with Effexor. Each drug has its uses and side effects. Talk to your healthcare provider before taking any antidepressant medication.

Clinical Trials and Side Effects of Effexor

Drugmakers must conduct clinical trials before submitting a drug to the Food and Drug Administration (FDA) for approval. These trials aim to determine a drug's safety and effectiveness. Drug companies also conduct clinical trials to market a drug for off-label uses.

Besides drug manufacturers, independent researchers also conduct clinical trials of various drugs, supplements, and vitamins. These trials are necessary because they alert experts (and the FDA) to potential health risks and dangers.

1993: FDA Approves Effexor

The FDA initially approved Effexor in capsule form in 1993. In 1997, the agency approved Wyeth's Effexor-XR (extended-release capsules) medication.

The FDA approved the drug to treat several disorders, including:

• Major depressive disorder
• Panic disorder and panic attacks
• Generalized anxiety disorder
• Social anxiety disorder (social phobia)

The FDA specifically warned that it didn't approve Effexor for use in children. The agency also warned doctors to use caution when prescribing the drug to patients with bipolar disorder. One of the side effects of Effexor was hypomania, and patients with bipolar disorder are already prone to manic episodes.

For more information on the side effects of Effexor, visit FindLaw's Effexor: Health Risks and Legal Action.

July 2006: FDA Says Combined Use of Effexor and Migraine Medicines Risky

The U.S. Food and Drug Administration (FDA) issued an alert about Effexor. The FDA announced the risks of taking selective serotonin reuptake inhibitors (SSRIs, such as Effexor) and triptans (used to treat migraine headaches).

Taking both medications can cause a life-threatening condition called serotonin syndrome.

Oct. 25, 2006: Wyeth Warns of Antidepressant Overdose Risk

Wyeth informed healthcare providers of a potential risk of overdose in Effexor patients. In a letter sent directly to prescribers, the drug manufacturer advised them to limit the number of pills they prescribed to each due to this risk.

According to Wyeth, "prescriptions for Effexor XR should be for the smallest quantity of capsules consistent with good patient management, to reduce the risk of overdose."

Dec. 5, 2006: FDA Clinical Trials of Suicidal Thoughts in Children and Adolescents

In 2006, the FDA reviewed the results of 24 separate studies on the impact Effexor and other psychiatric drugs had on patients with major depressive disorder (MDD). The studies the FDA cited involved 4,400 children and adolescents.

The FDA found that, when compared with a placebo, Effexor doubled a child or young adult's odds of developing suicidal thoughts and behaviors. Only 2% of participants in the placebo-controlled study had these thoughts compared with 4% of those in the group taking an antidepressant drug.

The results helped the FDA solidify its position that Effexor was not safe for pediatric patients.

2007: FDA Criticizes Effexor Advertisement

In 2007, the FDA announced that Wyeth's marketing of Effexor was misleading. Specifically, the FDA said the drugmaker's advertisement overstated the drug's effectiveness. It also found that the ad minimized the drug's risks.

The FDA posted a letter on its website and questioned Wyeth's claims. The agency also said it would heavily scrutinize the drug company's future advertisements and marketing materials for safety and transparency.

2010: FDA Approves Generic Version of Effexor

On June 28, 2010, the FDA approved a generic version of Effexor. Before a generic version of any prescription medication hits the market, the drug must have FDA approval. The generic drug undergoes the same scrutiny and review as any new drug.

The FDA approved TEVA Pharmaceutical's generic version of Effexor in 37.5mg, 75mg, and 150mg forms. The FDA approved the drug for the treatment of major depressive disorder. The agency emphasized that generic drugs make it easier for people to access safe and effective antidepressant medications.

March 2014: Pfizer Recalls Three Lots of Effexor

In March 2014, Pfizer and the FDA recalled three lots of Effexor XR and Pfizer's generic version of the drug. All three lots were 150 mg tablets. According to Pfizer, these lots contained another drug, Tikosyn.

Tikosyn is a drug for patients with a heart arrhythmia (atrial fibrillation). Patients taking Effexor for depression could be at risk of death if they accidentally took Tikosyn.

The drugmaker and the FDA notified doctors and the public of the recall. The alert directed patients with pills from these lots to return them to their pharmacy immediately.

Did Pfizer Discontinue Effexor?

Pfizer discontinued Effexor in 2004. The company said it was discontinuing the drug in the United States for business reasons. The drugmaker noted that patients taking the original version of Effexor had to take the drug two to three times a day. It made more sense to continue making the extended-release version of Effexor. The company was also marketing its generic version of the drug.

Others argued that the reason Pfizer took Effexor off the market was because too many patients were complaining of suicidal thoughts. Many claimed that the company discontinued the drug due to lawsuits over the drug's adverse side effects, including an increased risk of suicide.

What to Do if You Became Sick After Taking Effexor

If you or your loved one took Effexor and experienced severe side effects, you may have a legal claim. Talk to a product liability attorney so they can review your case.