Serzone (nefazodone) is an antidepressant doctors use to treat major depression, anxiety, and related health disorders. Bristol-Myers Squibb Company manufactured the drug, and the FDA approved it in 1994.
In 2001, worldwide sales of Serzone were around $409 million. But on May 19th, 2004, Bristol-Myers Squibb announced they would no longer sell the drug in the U.S. due to declining sales. They had already taken the drug off the market in Australia, Europe, and Canada.
The drugmaker said they stopped selling the antidepressant for business reasons. But many believe it was due to claims that Serzone caused liver failure.
Here, we'll provide an overview of Serzone. We will offer a brief history of the drug, including its side effects and health risks. Finally, we'll briefly explain what to do if you or a loved one becomes sick after taking Serzone or nefazodone.
Serzone and Potential Drug Interactions
Serzone is no longer available. But the generic version of the drug is still available. Doctors may prescribe the generic drug to patients with major depressive disorder.
Avoid taking nefazodone if you take any of the following prescription drugs:
Some of these drugs are no longer available. But you may still have some of them in your medicine cabinet.
Before you take any prescription drug, you must seek medical advice. Your doctor will evaluate your charts to ensure there are no adverse drug interactions. They can also confirm that you don't have an allergic reaction to the new drug.
Don't automatically take another pill after a missed dose of Serzone (or the generic). Ask your doctor whether to wait for your next dose or double up. Always keep your prescription medications at room temperature and out of reach of children.
Side Effects of Serzone
Serzone chemically differs from selective serotonin reuptake inhibitor (SSRI) and monoamine oxidase inhibitor (MAOI) antidepressants. It inhibits serotonin and norepinephrine uptake and blocks one type of serotonin receptor.
This blocking effect significantly decreases insomnia, weight gain, and lack of sexual interest that patients experience with other antidepressants. This doesn't mean Serzone didn't have adverse side effects.
The most common side effects of Serzone include:
- Dry mouth
- Blurred vision
If you notice these symptoms worsening, seek immediate attention. You should also call your healthcare professional if you experience any of the following adverse effects:
- Loss of appetite
- Abdominal pain
- Dark urine
Patients with liver problems should not take Serzone or nefazodone. Pregnant women and women hoping to become pregnant should avoid Serzone. The same applies to women who are breastfeeding.
Serious Risks: Liver Damage
In December of 2001, the U.S. Food and Drug Administration (FDA) told Bristol-Myers Squibb Co. it must include a black box warning on the label for Serzone. The warning had to include that patients taking Serzone can develop severe and possibly life-threatening liver problems.
In March 2002, the FDA cautioned the public that patients reported cases of life-threatening liver failure. There were over 109 cases, and in at least 23 of the cases, patients experienced liver failure.
Sixteen other patients underwent liver transplants or died. The FDA estimated that liver failure rates for Serzone patients were three to four times greater than for non-users.
In March 2003, the consumer group Public Citizen petitioned the FDA to ban Serzone from the U.S. market. The group cited the number of liver toxicity deaths purportedly related to the antidepressant.
Bristol Myer Squibb removed Serzone from the U.S. market in 2004. They did so after many claims of liver dysfunction after taking Serzone.
Serious Risks: Increased Depression and Suicidal Impulses
Antidepressant medications, including Serzone, came under scrutiny from the FDA. Studies and clinical trials have found that antidepressants can increase depression severity. It can also cause suicidal impulses in some patients.
In 2004, the FDA instructed manufacturers to include a "boxed warning" on the labels of antidepressant drugs. This boxed warning informs patients about the risk of suicidal behavior in children and adolescents.
Talk to Your Healthcare Provider Before Taking Nefazodone
You should never start an antidepressant without talking to your doctor. There are certain things they must know to help you avoid adverse drug interactions.
When considering taking nefazodone or any antidepressant, tell your healthcare provider if you have any of the following:
- Heart disease
- High or low blood pressure
- Irregular heartbeat
- Past or present manic episodes
- Kidney disease
- Liver disease
- Are pregnant or breastfeeding
Also, let your doctor know if you're currently taking other antidepressants or medications. This includes vitamins and supplements. If you're a caregiver for a loved one with depression, tell your family member's doctor what medications they're taking.
What To Do if You're Hurt After Taking Serzone
Serzone has been off the market for close to 20 years. But the generic version is still available. If you or your loved one get sick after taking nefazodone, seek immediate medical attention. You should also speak with an experienced product liability attorney.
Depending on the facts of your case, you may have a legal claim against the drug manufacturer. All drugmakers have a legal duty to make their products as safe as possible. They must also notify prescribers and the public of the risks of their drugs.
If the pharmaceutical company doesn't do this, the court may hold them liable for your injuries.
You may also have a claim against your doctor for medical malpractice. For example, if your doctor didn't tell you about nefazodone's side effects and risks, you may be able to sue them.
Regardless of which type of lawsuit you file, your personal injury lawyer will demand the following damages:
- Medical bills and future medical expenses
- Lost wages and lost future income
- Pain and suffering
- Punitive damages (in limited cases)
- Burial and funeral expenses (in wrongful death lawsuits)
Your compensation will depend on the nature and severity of your injuries.
Contact a Personal Injury Attorney
If you or a loved one becomes sick after taking any medication, seek immediate medical attention. You should also talk to an experienced personal injury lawyer. Keep in mind, Serzone has been off the market for a long time. You may have missed the statute of limitations period to sue the drug manufacturer. Your lawyer must prove that you didn't discover your injury until now. Even then, the judge may not allow you to sue.
The best way to know if you have a valid claim is to talk to a seasoned product liability lawyer. Visit FindLaw.com's attorney directory to find a lawyer near you.
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Contact a qualified product liability attorney to make sure your rights are protected.