The Federal Drug Administration (FDA) says it's considering the use of antipsychotic drugs in a study. A federal appeals court in New York last month agreed with the agency's analysis of the risks associated with certain antipsychotic drugs, finding the drugs had a greater risk of serious cardiovascular and psychiatric side effects than similar drugs used for schizophrenia.
But the FDA has said it wants to keep antipsychotic drugs out of the United States market, because of their safety problems.
The agency said that the drug's manufacturer, Sanofi-Aventis, said its drug safety review showed it could cause a rare and potentially fatal condition known as serotonin syndrome, or Seroquel syndrome.
"We believe this is a serious drug safety problem, and that is a serious risk of serious disease and death that cannot be overlooked," said Dr. Steven Nissen, a urologist at New York's Lenox Hill Hospital.
Nissen said the FDA has not recommended to prescribe Seroquel XR, the generic version of antipsychotic drug Seroquel, to patients with Seroquel XR, or anyone with a history of Seroquel use. Patients with a history of Seroquel use may have had serious side effects from taking the drug.
In March, a federal appeals court in Colorado ruled that the agency should not have allowed the use of antipsychotic drugs in children and adolescents because the drugs are similar in several ways, including their side effects, risks and interactions with other medications.
The court also found the drugs were not safe to use in children and adolescents because there was no evidence that they could cause death.
The drug safety review found the risk of Seroquel syndrome in children and adolescents was not greater than in adults, but the drug was not associated with increased rates of suicidal thoughts or behavior in children and adolescents.
The FDA said the risk is higher in children and adolescents with severe psychiatric problems, such as schizophrenia, and in patients with a history of substance abuse. But the agency's review did not include a full review of the drug's safety, or of whether it caused Seroquel syndrome.
The agency said the agency found that the risk of Seroquel syndrome in children and adolescents was significantly greater than in adults, but that it did not show the risk to be greater in patients with a history of Seroquel use.
"The risk of Seroquel syndrome in patients with a history of substance abuse is significantly greater than in patients with a history of Seroquel use," said the FDA's director, Dr. David Kaminak, in a news release.
FDA spokeswoman Mary Lou Smith said the agency was not concerned with the risk of Seroquel syndrome in children and adolescents.
"We are concerned that Seroquel syndrome was not associated with increased risk of psychiatric adverse events such as suicidal thoughts or behavior," Smith said. "We are pleased with the results of the FDA review of Seroquel XR and its associated adverse events."
The FDA said it is not making any new drug safety recommendations.
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Medically reviewed by Jessica Swirble, PharmDLast updated on March 26, 2025
Drug Information| | |
Quetiapine tablets are primarily used to manageknown short-term depression (such as obsessive compulsive disorder and depressive episodes). The drug's active ingredientseroquel 20mgis anatypical serotonin reuptake inhibitor, often used in conjunction with other antidepressant medications to improve efficacy and reduce the risk of side effects. The tablets are typically taken once daily, with or without food.
However, Quetiapine is also used offlabel to treat obsessive compulsive disorder, panic disorder, and depressive episodes in adolescents and adults with bipolar disorder.
Quetiapine belongs to a class of drugs known asserotonin-norepinephrine reuptake inhibitors. It works by increasing the amount of Serotonin in the brain, which helps reduce obsessive compulsive disorder, panic disorder, and depressive episodes.
However, it's important to note that Quetiapine does not treat bipolar disorder or Major Depressive Disorder (MDD).
Quetiapine belongs to a different class of drug known asparoxetineIt is used to treat depression, but it does not treat bipolar disorder or depressive disorder.
However, it may take several weeks of daily use for the full effect.
The use of Quetiapine is not intended for everyone who administers it, age 13 - 24 years, aged 50 - 64 years, or are past their peak use. However, it's crucial to consider potential side effects and drug interactions before use.
In addition, Quetiapine is often prescribed for conditions not listed on the medication's Tylenol Counter Status. The use of Quetiapine is not intended for women or children.
The use of Quetiapine is not intended for men or children. It's advisable to consult with your doctor.
If you experience any side effects, such as agitation, confusion, diarrhea, nausea, vomiting, or headache, discontinue use and consult your doctor.
Quetiapine may cause dizziness or drowsiness, especially when rising or going slow, especially if you're sitting or lying down.
Dr. Swirble can help you differentiate the cause of your side effects from more serious side effects. If you're experiencing side effects that don't improve after 7 - 10 days, speak with a healthcare provider to determine whether they are a substitute for using Quetiapine.
If you experience severe side effects, such as slowed thinking or memory problems, seek medical attention immediately. These may be symptoms of a more serious condition, such as dementia, and may require dosage adjustments as needed.
Inform your doctor about any medications or supplements you are taking as they may interact with Quetiapine, as they may affect how this drug is metabolized, cause adverse reactions, or increase your risk for adverse events.
Quetiapine may be used for other unwell conditions, such as depression, but it may be prescribed for other conditions because it works by increasing serotonin levels in the brain.
In addition, inform your doctor about any allergies or other medications you are currently using or are currently taking before starting Quetiapine.
Seroquel (Quetiapine) is an atypical antipsychotic medication used to treat major depressive disorder and schizophrenia. It is part of a class of drugs called anti-psychotic medications. It is available in various forms, including tablets, oral suspensions, and injectable forms. Your doctor will prescribe the best fit for you depending on your medical condition.
The best time to take Seroquel is within 1 to 2 hours after taking the medication. However, it can be taken with or without food. The dose can be increased the same as the prescribed amount by your doctor. Keep in mind that you should only take Seroquel if you are taking or have taken an anti-psychotic medication before you start taking a drug.
It is important to note that Seroquel can cause side effects such as nausea, diarrhea, and vomiting. These side effects should subside as your doctor is in charge of you through the use of your daily routine.
You should not take Seroquel if you are allergic to quetiapine. Before taking Seroquel inform your doctor if you have any history of heart problems, high or low blood pressure, any kidney problems, or are on dialysis.
Seroquel can increase your risk of developing bipolar disorder or schizophrenia. Bipolar disorder is a mental health condition that causes you to have episodes of depression, mania, or depression while you are on Seroquel. Bipolar disorder may be a sign of more serious a condition such as a certain type of cancer, multiple myeloma, or a certain heart disease.
Taking Seroquel with certain foods can increase the risk of certain side effects such as constipation, nausea, and vomiting. You should avoid drinking grapefruit juice while taking Seroquel as it may lead to the growth of cancer cells in your body.
You should not take Seroquel if you are taking any type of medication such as antipsychotic, anti-fungal, HIV medication, or pain medication. You should not take Seroquel if you are allergic to quetiapine, or if you have ever had an allergic reaction to quetiapine, it is not known if Seroquel can cause an allergic reaction, or if it is not known.
Before taking Seroquel, tell your doctor if you are suffering from any mental health illness, depression, or have a disease that can cause bipolar disorder.
Seroquel can increase the risk of certain side effects such as constipation, nausea, and vomiting. It is important to mention any medical conditions that you are currently having with your doctor or pharmacist as Seroquel can interfere with your diet and lead to weight loss.
You should not use Seroquel if you are taking any form of medication such as a diuretic (tic, urea), blood pressure medication (warfarin, triamci), oral medication (fluconazole), or injectable medication.
You should not take a double dose of Seroquel if you are missed a dose.
A
Q:I had a conversation with my doctor about the antidepressant, but she suggested that I try quetiapine (AstraZeneca) and the coupon. The manufacturer said it would give me $15.00 a month and would help me lose weight. It's been a while since I've tried it.
A:
I was on a $15 prescription for a year-long course of quetiapine. I was taking an antacid to take at bedtime. It was really helpful. The doctor said I needed to take it for the next two weeks. I have a feeling it will help me lose weight. Do you have any advice?
I had a conversation with my doctor several months ago about the antidepressant, but she suggested that I try quetiapine and see if that worked for me. I was on an antacid for the last two weeks, but the doctor suggested I try another one of these drugs. Is there anything else I should be aware of before taking this medication?
I have a friend who is also on a long term treatment for bipolar disorder. She's had bipolar episodes for a little over a year now, but nothing serious has been diagnosed. What should I do?
Before this, I could only take one tablet every few weeks, but now I only take one tablet a day.
I'm a little concerned about my weight because I've lost about 2 lbs in the last month. Is this normal? What are the risks?
I've been losing weight on Seroquel for the past 4 years.
I'm a patient with bipolar disorder. I've had episodes of depression. My doctor recommended quetiapine, but since I've been on it, I'm not sure if it's safe.
I've had episodes of panic attacks.
I've been on an antidepressant for about two years. I'm in my mid-40s. I'm not sure if it's safe. Do you have any specific questions about taking it?
I've taken it for several years. I was struggling with my weight, but it helped me lose weight.
I'm also a patient of the National Institute for Health Care Excellence, which is responsible for making sure health care professionals get the care they need.
I've been taking it for several years. I've been losing weight regularly.
I was prescribed quetiapine. I haven't been taking it for two years and my doctor recommended it.
I was taking it a couple of months before my doctor suggested it. I haven't had any episodes of panic attacks for several years.
I'm taking it every week. I'm losing weight on it. Can I lose it?
I'm not sure if it's safe to take it every week. Do you recommend I lose it?
I've been on it for a year and a half and I've lost 2 pounds.
I'm on it daily.