Symbyax: Health Risks and Legal Information

Symbyax (olanzipine/fluoxetine) is a prescription medication for adults with depression with bipolar disorder. This is a mental health condition that causes extreme mood swings. Eli Lilly and Company manufactures Symbyax. The U.S. Food and Drug Administration (FDA) approved the medication in 2003.

In March 2009, the FDA approved Symbyax to treat depression. The original FDA approval was only for bipolar depression. It took Eli Lilly several attempts to secure approval for Symbyax to treat treatment-resistant depression.

This page discusses the uses and side effects of Symbyax. You’ll find important legal information, including lawsuits, recalls, and warnings regarding the drug. It also explains what to do if you or a loved one becomes sick after taking this medication.

Drug manufacturers must ensure their medications are safe to use and carry adequate warnings. If not, they can be legally responsible if a patient develops an illness as a result of using their product. A product liability attorney near you can review your situation and determine if you have a valid legal claim. If so, they will advocate for fair compensation for your injuries.

What Is Symbyax?

Symbyax contains two medications: olanzapine (Zyprexa) and fluoxetine (Prozac).

Olanzapine is an atypical antipsychotic drug. It treats symptoms of schizophrenia such as hearing voices, seeing things that aren’t there, mistaken beliefs, etc.

Fluoxetine, or Prozac, is a selective serotonin reuptake inhibitor (SSRI) that helps regulate mood. It is an antidepressant drug that also treats panic disorder and obsessive-compulsive disorder (OCD).

Doctors also prescribe Symbyax for off-label uses such as:

• Anxiety
• Eating disorders
• Post-traumatic stress disorder (PTSD)

One of Symbyax’s major rivals is Bristol Myers Squibb’s Abilify. Eli Lilly and Company manufactures Symbyax. It markets the drug to patients suffering from depressive episodes of bipolar disorder. Experts suggest clinicians use the drug only in extreme cases, such as nursing home residents and children with severe behavioral disorders.

Symbyax Side Effects

Almost every drug has side effects. Most are minor. Unfortunately, bipolar depression patients may also experience severe side effects while taking Symbyax.

The common side effects of Symbyax are:

• Sleepiness
• Dry mouth
• Restlessness
• Diarrhea
• Constipation
• Muscle stiffness
• Weight gain
• Tremors

Some of the serious side effects of Symbyax include:

• Low blood pressure
• Dizziness or fainting
• Blurred vision
• Increased heartbeat
• Seizures
• Liver problems
• Difficulty swallowing

If you notice any severe side effects while taking this medication, seek immediate medical attention. This also applies if you experience an allergic reaction while taking Symbyax.

Serious Health Risks of Symbyax

Aside from the above side effects, there are also health risks from taking Symbyax. Over the years, the FDA has issued alerts about these dangers.

Some of the health risks of Symbyax include:

• An increased risk of suicidal thoughts, behaviors, or actions
• Increased chance of death in older adults
• Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem
• Tardive dyskinesia (TD)
• High blood sugar and diabetes
• Strokes in older adults with dementia
• Bleeding problems
• Mania
• Low salt levels
• Sexual problems
• Increased risk of death in older patients with dementia-related psychosis

Before you take any prescription drug, read the medication guide. Drug manufacturers must include warnings of these health risks in their packaging.

What To Tell Your Doctor Before Taking Symbyax

Before you start taking Symbyax, talk to your healthcare professional. They need to know if you’re taking other medications, including over-the-counter ones. You must also tell them if you are suffering from any medical conditions.

Specifically, tell your doctor if you currently have or have suffered from any of the following:

• Heart problems
• Seizures
• Diabetes
• Liver disease
• High blood pressure
• Trouble breathing
• Hyperglycemia

Let your doctor know if you are taking any of the following:

• Prozac
• Zyprexa
• Linezolid (Zyvox)
• Any other SNRIs
• Tryptophan
• NSAIDs like ibuprofen or naproxen
• St. John’s Wort
• Citalopram (Celexa)
• Flecainide (Tambocor)

You should also tell your doctor if you are pregnant, trying to get pregnant, or breastfeeding. Your healthcare provider will ensure there’s no risk of adverse drug interactions between these medications and Symbyax.

Avoid drinking alcohol while taking Symbyax. As with any medication, also avoid using recreational drugs.

Who Should Not Take Symbyax?

You should not take Symbyax if you take other antidepressants, such as a monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking these two drugs close in time can cause severe reactions, including the following:

• High body temperature
• Coma
• Seizures

In rare cases, this reaction can cause a risk of death in patients. Never take Symbyax if you are taking Mellaril (thioridazine), a drug used to treat schizophrenia. Taking Symbyax and Mellaril together can cause serious heartbeat problems.

Symbyax and Serotonin Syndrome

Another serious health risk of Symbyax is serotonin syndrome. In July 2006, the FDA issued an alert to doctors and the public about selective serotonin reuptake inhibitors (SSRIs), a life-threatening condition.

This condition occurs when you take Symbyax and migraine medications known as 5-hydroxytryptamine receptor agonists (triptans).

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
• Coma
• Nausea
• Vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. If you take migraine headache medicines, ask your doctor if your medicine is a triptan.

Adverse Health Consequences and Symbyax Lawsuits

Millions of Americans have a mental illness. This explains why there are so many prescription drugs on the market. Unfortunately, most of these drugs have serious side effects. These adverse events can be quite severe and can even lead to death.

Over the years, the FDA has warned the public about the risks of Symbyax. Also, many plaintiffs have sued after experiencing severe health consequences from taking Symbyax.

Young Symbyax Patients May Have Suicidal Thoughts

In 2013, the FDA published a detailed warning that Symbyax may cause suicidal thoughts in children and young adults. This is especially true for people with a family history of bipolar disorder. In 2004, the FDA ordered Eli Lilly to add a black box warning about this risk.

According to the FDA’s alert, children and adolescents under 24 are most vulnerable to having suicidal thoughts. The risk is highest during the first few months of treatment.

Symbyax and Increased Risk of Rare Skin Disease

In May 2016, the FDA ordered drug manufacturers to add a new boxed warning to all drugs containing olanzapine. According to the FDA, these drugs cause a rare condition, “Drug Reactions with Eosinophilia and Systemic Symptoms” (DRESS). The FDA alert targeted several prescription drugs, including Symbyax, Zyprexa, and Relprevv.

DRESS causes your body to produce high levels of white blood cells. This leads to inflammation and swelling. The skin condition spreads throughout your body. It affects the:

• Liver
• Kidneys
• Lungs
• Heart
• Pancreas

In severe cases, DRESS can be fatal. It is critical to know the risks of taking Symbyax before taking this medication.

Risk of Congenital Disabilities if Pregnant Women Take Symbyax

Pregnant women who take Symbyax are at risk of having babies with congenital disabilities. Infants born to pregnant women taking Symbyax are at risk of the following conditions:

• Spina bifida
• Heart and lung defects
• Skull and brain defects
• Persistent pulmonary hypertension of the newborn
• Cleft palate
• Premature birth

All these are serious and can lead to death. If you’re pregnant or thinking about becoming pregnant, avoid taking this drug. Your doctor can discuss other treatment options to help protect you and your child.

FDA Issues Warning Regarding Symbyax and Pregnancy

In July 2006, the FDA issued a separate alert regarding Symbyax and pregnant women. A study found that using antidepressant medicines during pregnancy may cause persistent pulmonary hypertension in the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through their hearts and lungs. Babies born with PPHN can become very sick and may die.

Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies were six times as likely to have PPHN.

Can You Sue if You Suffer Harm From Symbyax?

Pharmaceutical companies must ensure their prescription medications are safe. They must also include warnings about side effects in their prescribing information. They may be liable for any injuries if they fail to do this.

If you believe a drug manufacturer withheld information about risk factors or dangerous side effects, you can sue them. You can only file a legal claim if you got hurt. It’s not enough that a drug is dangerous. Your personal injury lawyer must show that the drugmaker’s failure to warn caused you harm.

If you’re able to prove that the drug company is liable for your injuries, you may recover the following types of damages:

• Compensation for medical bills and future medical expenses
• Damages for pain and suffering
• Punitive damages

Judges rarely order a defendant to pay punitive damages. But the odds of this happening in a dangerous drug case are higher than they are in other injury cases. The drug company knows it has a duty to warn.

Drug companies are in the best position to determine whether their drug has dangerous side effects. They are also best positioned to warn the public about these effects.

Get Legal Help With Your Symbyax Claim

Researchers have linked Symbyax to several health risks, particularly birth injuries to children whose mothers took the drug during pregnancy. If you or your loved one develops an illness after taking Symbyax, seek immediate medical attention. Then, consider talking to an experienced attorney. This can help you protect your rights and decide whether you have a valid claim.

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.