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FDA Advisories for Antidepressants

Overview

The U.S. Food and Drug Administration (FDA) has issued advisories to patients, families, and health professionals to closely watch for warning signs of suicidal behavior in children and adults younger than 25 who take antidepressants.

The FDA also advises patients to watch for an increase in anxiety, panic attacks, agitation, irritability, insomnia, impulsivity, hostility, and mania. It is most important to watch for these behaviors in children. That's because children are less able to control their impulses. They may be at greater risk for suicidal behaviors.

The FDA has not recommended that children and young adults stop using antidepressants. If you have concerns about a child or young adult who is taking an antidepressant, talk to a doctor.

If your child is taking an antidepressant, watch carefully for warning signs. Pay extra attention during the first few weeks of treatment and when doses are changed. If you are concerned about the FDA advisory or about warning signs of suicide, talk to your child's doctor.

No one should ever stop taking antidepressants suddenly. These medicines should be tapered off slowly and only under the supervision of a health professional. Abruptly stopping antidepressants can cause side effects or a relapse into another depressive episode.

Suicidal thoughts

Suicidal thoughts and behavior are a risk for an antidepressant. But the FDA recognizes that for many young people, the benefits of taking an antidepressant may be greater than the risks. Just make sure to follow the FDA's precautions. Left untreated, depression can cause a number of long-term problems, including suicidal behavior. For some young people, taking an antidepressant can help ease the symptoms of depression and may reduce the risk of suicide in the long run.

Actions

The FDA has asked drug companies to include in their packaging inserts a "black box" warning. This is the government's strongest medicine warning. The warning is in bold letters inside a black box. It recommends that anyone thinking about using that drug (or any antidepressant) in a child or young adult needs to carefully balance the risk of taking the drug with the need to use it. It also recommends that family members and caregivers closely watch for warning signs of suicide in a child or young adult who takes an antidepressant.

The black box warning notes the drug's approved uses. Right now, only certain antidepressants are approved for use in children and teens. But other antidepressants are commonly used. Health professionals often prescribe medicines that are not specifically approved but may still be safe and effective. This is called unlabeled use.

The FDA also requests that a Patient Medication Guide (MedGuide) be handed out with each prescription or refill of a medicine. This guide has user-friendly information about suicide risk and the precautions you can take.

Credits

Current as of: July 31, 2024

Author: Ignite Healthwise, LLC Staff
Clinical Review Board
All Ignite Healthwise, LLC education is reviewed by a team that includes physicians, nurses, advanced practitioners, registered dieticians, and other healthcare professionals.

Current as of: July 31, 2024

Author: Ignite Healthwise, LLC Staff

Clinical Review Board
All Ignite Healthwise, LLC education is reviewed by a team that includes physicians, nurses, advanced practitioners, registered dieticians, and other healthcare professionals.

Dear patient

I am excited to announce that I will be relocating my practice to Houston Methodist DeBakey Cardiology Associates. Starting November 4, 2024, my new address will be:

5115 Fannin, Suite 801
Houston, TX 77004

Please note that my phone number and fax number will also change to the following:
24-Hour Telephone: 713-441-1100
Fax: 713-790-2643
Clinical Support Telephone (M-F, 8-5): 713-441-3515

I am excited about caring for you in my new office and hope you will make the transition with me. I will also continue to refill your medications as I have in the past. To assist, please provide your pharmacy with my new contact information.

Please consider checking your prescription refills to verify that you have enough medication on hand to last you until your next visit. Please note that your medical records will remain at my former office until you authorize their transfer. If you choose for me to continue providing your medical care, please complete and sign the enclosed “Authorization for Release of Medical Records” form and fax it to 713-790-2643. Once we receive your authorization, we will be happy to process the request for you.

Thank you for entrusting me with your medical care. My new team and I are dedicated to making this transition as seamless as possible. For help scheduling an appointment and transitioning your care, please call my new office number above.

I look forward to continuing your care at my new location.

Sincerely,
Gopi A. Shah, MD

Dear patient

Dr. Albert Raizner, Dr. Michael Raizner, and Dr. Mohamed El-Beheary are excited to announce that our practice, Interventional Cardiology Associates, will merge with Houston Cardiovascular Associates on November 1, 2024.

Our new offices are similarly located in Houston, near the Texas Medical Center and in Sugar Land. Our in-hospital care will continue at Houston Methodist Hospital in the Texas Medical Center and Houston Methodist Sugar Land Hospital. Importantly, our new offices expand our services with state-of-the-art equipment and amenities. Our core values will always be, as they began over 40 years ago when Dr. Albert Raizner founded ICA:

Integrity – Compassion – Accountability

Our new address and contact information are:

Your medical records are confidential and remain available at our new locations. We consider it a privilege to serve as your cardiologists and look forward to your continuing with us. However, should you desire to transfer to another physician, you may request a copy of your records by contacting us at our new addresses and phone numbers listed above.

We thank you for your trust and loyalty. As always, we will continue to be here to take care of you. Please do not hesitate to contact us if you have any questions or concerns.

Sincerely,

Dr. Albert Raizner,
Dr. Michael Raizner,
Dr. Mohamed El-Beheary