Drug Notebook

FDA Alerts

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

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traZODONE
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(TRAZ oh done)

What is the most important information I should know about trazodone?

Before taking trazodone, tell your doctor if you are allergic to any drugs, or if you have bipolar disorder (manic depression), schizophrenia or other psychiatric illness, a history of drug abuse or suicidal thoughts, or if you have recently had a heart attack.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Trazodone works best if you take it after a meal or a snack. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Trazodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking trazodone. Alcohol can increase drowsiness and dizziness caused by trazodone. Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 4 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

What is trazodone?

Trazodone is an antidepressant medication. It affects chemicals in the brain that may become unbalanced and cause depression

Trazodone is used to treat depression.

Trazodone may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking trazodone?

Do not use this medication if you are allergic to trazodone.

Before using trazodone, tell your doctor if you are allergic to any drugs, or if you have:

  • bipolar disorder (manic depression);

  • schizophrenia, or other psychiatric illness;

  • a history of drug abuse or suicidal thoughts; or

  • if you have recently had a heart attack.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trazodone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give trazodone to anyone younger than 18 years old without the advice of a doctor.
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