Navigation Links
FDA Advisory Against Anti-depressants to Be Expanded to Cover Young Adults too

Anti-depressants could indeed lift one out of depression. But its potential to drive teenagers to suicide has already been recognized//.

Now the U.S. Food and Drug Administration (FDA) has proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, in young adults ages 18 to 24 during initial treatment, generally the first one to two months.

Back in March 2004, the FDA had said –

Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases. Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

They should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric, it had said then.

Although FDA had not concluded that these symptoms were a precursor to either worsening of depression or the emergence of suicidal impulses, it had expressed concern that patients who experienced one or more of such symptoms might be at increased risk for worsening depression or suicidality.

Antidepressants wo rk by increasing the activity of certain chemicals work in our brains called neurotransmitters. They pass signals from one brain cell to another. The chemicals most involved in depression are thought to be Serotonin and Noradreline.

The Royal College of Psychiatrists notes in the case of drugs that inhibit serotonin receptors, the SSRIs, in the first couple of weeks of taking them, you may feel sick and more anxious.

Some of these tablets can produce nasty indigestion, but you can usually stop this by taking them with food. More seriously, they may interfere with your sexual function. There have been reports of episodes of aggression, although these are rare.

It also says, "There is no clear evidence of an increased risk of self-harm and suicidal thoughts in adults of 18 years or over. But, individuals mature at different rates. Young adults are more likely to commit suicide than older adults, so a young adult should be particularly closely monitored if he or she takes an SSRI antidepressant." Such is the conventional wisdom.

But on Wednesday the FDA asked makers of anti-depressants to expand the warning labels to include adults age 18-24.

Eli Lilly and Co., the maker of Prozac, Zoloft manufacturer Pfizer Inc. and other pharmaceutical companies said they would comply with the FDA's request.

"We believe this step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions while minimizing the fear and stigma associated with depression," Eli Lilly said in a statement.

Pfizer spokeswoman Shreya Prudlo said the company would update its label, which she said already calls for close monitoring of patients when they begin taking Zoloft. She added, however, "There is no established causal link between Zoloft and suicide in adults, young adults or children."

The proposed labeling chang es would note that studies have not shown this increased risk in adults older than 24 and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior.

The expanded warnings would emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," said Dr. Steven Galson, the FDA's drugs chief.

Still, any risks are said to be small. For every 1,000 patients 18-24 treated with antidepressants, the FDA would expect there would be five additional patients who have suicidal thoughts or exhibit suicidal behavior, said Dr. Thomas Laughren, who oversees psychiatric drugs for the FDA. The FDA analysis was based on studies of 11 antidepressants in more than 77,000 patients.

The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others apprehend they could keep drugs from those who need them.
GPL/B
'"/>




Related medicine news :

1. FDA Issues Public Health Advisory on Tysabri, a New Drug for MS
2. Doctors Said – ‘Stop Pressurising NHS Advisory Bod’
3. Mercks Pain Reliever Arcoxia Rejected by US Federal Advisory Panel
4. AAI Pharma Files Lawsuit Against Dr. Reddys Laboratories
5. Diabetics Need to Guard Against Nail Fungus
6. New Weapon Against Germs
7. Estrogen Found To Protect the Colon Against Cancer
8. Diet Found To Offer Protection Against Leukemia
9. Olive Oil Found To Offer A Protective Effect Against Breast Cancer
10. WHO Issues Caution Against Bird Flu Epidemic
11. New Supplement Found To Be Effective Against Sunburn
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:12/2/2016)... ... December 02, 2016 , ... Advanced Inc., a leading provider of travel ... CPA, MBA to serve as Advanced Inc.’s Chief Financial Officer, effective December 1, 2016. ... brings extensive financial and operational leadership experience to Advanced Inc. He began his career ...
(Date:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. Vivek ... Dr. Murthy explains how he was inspired to practice medicine at an early age ... is about more than making diagnoses and prescribing medicine,” he states. “It is about ...
(Date:12/2/2016)... New York, NY (PRWEB) , ... December 02, 2016 , ... ... from high school and while 84 percent of parents report speaking with their child ... control, pornography and sexually transmitted diseases. , Mediaplanet is proud to announce the launch ...
(Date:12/2/2016)... ... December 02, 2016 , ... Universal Medical ... systems and the first company to offer robotic imaging to veterinary medicine is ... booth # 941 for the American Association of Equine Practitioners 62nd Annual Convention ...
(Date:12/2/2016)... ... December 02, 2016 , ... "Pro3rd Accents Volume 2 ... to create versatile lower third titles with just a few clicks of the mouse," ... 2 includes 30 lower third animations. Choose from various styles with accented animations, rigid ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... bioLytical Laboratories, un líder mundial en test rápidos de enfermedades infecciosas, presentó ... a los miembros de la Kenya Pharmaceutical Association. ... ... Test! (PRNewsFoto/bioLytical Laboratories) ... ) bioLytical fue invitada por la Clinton Health Access Initiative ...
(Date:12/2/2016)... , December 2, 2016 According to ... "Global Market Study on Automated Endoscope Reprocessors: Single Basin Automated ... of 8.6% Between 2016 and 2024 " the global automated endoscope reprocessors ... expected to expand at a CAGR of 7.2% during an ... US$ 1,367.6 Mn by 2024. ...
(Date:12/2/2016)... FRANCISCO , Dec. 2, 2016  PipelineRx, a ... telepharmacy, will be offering demonstrations of its SaaS-based ... Society of Health-System Pharmacists 2016 Midyear Clinical Meeting ... Vegas . With nearly 300 hospital clients ... services and technology designed to dramatically improve pharmacy ...
Breaking Medicine Technology: