What is the black box warning for Seroquel?

What is the black box warning for Seroquel?

“The boxed warning will say that elderly patients with dementia-related psychosis and treated with antipsychotics have an increased risk of death,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research, at a June 16 press conference.

Is Seroquel approved by the FDA?

SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.

What are the FDA indications for Seroquel?

SEROQUEL is indicated for the treatment of both: • depressive episodes associated with bipolar disorder • acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex.

Does Seroquel cause permanent damage?

Over time, especially if abused, Seroquel can lead to the development of several adverse, and potentially long-lasting side effects. In some instances, these effects are reversible when use of the drug ends, but in other situations, the changes can be permanent.

What does Seroquel do to a normal person?

It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.

Who should not take Seroquel?

You should not use quetiapine if you are allergic to it. Quetiapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use. Quetiapine is not approved for use by anyone younger than 10 years old.

Who should not use Seroquel?

Is quetiapine a serious drug?

Warnings: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems.

Does Seroquel change your brain?

A: Seroquel (quetiapine) is an atypical antipsychotic. It works in the brain to change the activity of neurotransmitters. The main ones it affects are serotonin and dopamine.

What does Seroquel do to your brain?

Quetiapine works by blocking the receptors in the brain that dopamine acts on. This prevents the excessive activity of dopamine and helps to control symptoms of schizophrenia and manic depression.

Can u get addicted to Seroquel?

Quetiapine is an atypical or second-generation antipsychotic agent and has been a subject of a series of case report and suggested to have the potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive.

What are the rare side effects of Seroquel?

Rare

  • Dry, puffy skin.
  • fast, pounding, or irregular heartbeat.
  • menstrual changes.
  • unusual secretion of milk (in females)
  • weight gain.

What should you not take with Seroquel?

Drugs you should not use with quetiapine

  • Anti-arrhythmic drugs such as quinidine, procainamide, amiodarone or sotalol.
  • Antipsychotic drugs such as ziprasidone, chlorpromazine, or thioridazine.
  • Antibiotics such as gatifloxacin or moxifloxacin.
  • Pentamidine.
  • Methadone.

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