Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, August 28, 2015

Talking About the Unintentional Effects

Let's take a peek at the FDA's warning on antidepressants.
Despite prescribe-ability of SSRIs and other antidepressants, studies have shown that their unintentional effects on some people, especially adolescents and young adults could be detrimental. 
In 2004, the Food and Drug Administration (FDA) did conduct a review of clinical trials of antidepressants that involved nearly 4,400 children and adolescents. 
It revealed that 4% of those taking antidepressants thought about or attempted suicide (compared to 2 percent of those receiving placebos). 
Given that all of these kids had diagnosed a mental illness, antidepressants did double up on suicidal thinking and behaviors.
This had prompted the FDA to adopt a "black box" warning label on all antidepressant medications. It is the most serious type of warning on prescription drug labeling.
That was their effort to alert the public about the potential increased risk of suicidal thinking or attempts in children and adolescents taking antidepressants. The FDA later suggested that young adults up through age 24 may be affected as well. 
They emphasizes that all patients taking antidepressants should be closely monitored, especially during the initial weeks of treatment. How will healthcare providers accommodate this? Will they have time for it? 
Side effects may worsen depression. 
They include suicidal thinking or behavior, or any unusual changes in behavior such as sleeplessness, agitation, or withdrawal from normal social situations. 
To be safe, it takes families and caregivers together to pay close attention and to monitor and report any changes on behalf of the person being cared for.
A review of children and adolescents with major depression and anxiety disorders conducted between 1988 and 2006 showed that they did benefit from taking meds. This may be due to the severe nature of their mental illness. 
If your child is showing a mental illness tendency, does it worth your time to find out and confirm more before you get an antidepressant? I find it to be an uphill battle to talk to doctors sometimes. But I won't give up.
The latest information from the FDA can be found on their website.

Tuesday, August 25, 2015

You and MedWatch

MedWatch is a new web based reporting program designed by the FDA, the U.S. Food and Drug Administration. 

In this information era, it is the agency's crowdsourced effort to fulfill its mission, protecting and promoting health.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program.

Follow this link MedWatch form to report adverse events that you observe in drugs and medicines that you and your family use, whether it is a prescription or over-the-counter product.

You can take note and report serious drug side effects from the comfort of your home, not having to wait till the next appointment with a doctor to do so.

Other concerns such as product use errors, product quality problems, and therapeutic failures could also be reported there at the site.

What's more? The FDA is also gathering up adverse information about dietary supplements, infant formulas, cosmetics and foods/beverages sold on the market. 

The information you provide will directly help FDA's effort to monitor and regulate these products. It is by far the best way.