Strattera Linked to Child Suicidal Thoughts.
Adding to the "Black Box" warning that Strattera can cause liver
problems comes a new warning that Strattera can cause suicidal
thoughts in children taking the ADHD drug.
After a recent study, it was discovered that a child or adolescent
could have suicidal thoughts while on the medicine. The FDA is now
making the company put a warning label on its product about the
Strattera/child suicide connection.
This newest warning, released yesterday (Sept. 29 2005), is the
result of re-analyzed trial data. At the request of the FDA, Lilly
re-analyzed its data from trials performed on 1,357 children and
adolescents. Of them, five children reported having suicidal
thoughts, including one child who attempted suicide. Not one child
in the 851 children studied in the placebo group had suicidal
thoughts or actions.
Dr. John R. Hayes, vice president of Lilly Research Laboratories,
urged "appropriate vigilance" in watching for signs of suicidal
thoughts when a child takes Strattera.
About 3.4 million people have used Strattera since it became
available in 2003. Of those, about 75 percent are children. Many
doctors and parents applauded Lilly when they manufactured
Strattera - the first non-stimulant ADHD drug. However, the
initial enthusiam waned quickly after the general population began
using the drug in 2003. Harsh side effects, especially sexual side
effects in adults, were reported. Some studies suggested that, in
addition to more side effects, Strattera appeared less effective
than the stimulant medications. Then, in 2004, Lilly issued its
first Black Box warning - the strongest warning that can be
attached to a prescription medication - for its detrimental
effects on the liver.
Lilly will add to the warning label about liver problems with the
new warning about suicidal thoughts on the drug's label in the
box. The Black Box warning is the most serious level for a label
warning under the Federal Drug Administration's guidelines.
At the FDA's request, Lilly will also publish a guide for doctors
and pharmacists to give to patients taking Strattera. Lilly will
also put the warning label on boxes that are sold in other
countries. Lilly reps said that the FDA's warning about suicidal
thoughts reflects "the scientific community's growing
understanding of suicide-related behaviors and how to analyze
them." The FDA is now reviewing all attention deficit disorder
drugs to look for adverse reactions. This review should be
completed in 2006.
The FDA is currently conducting a review of the reports of more
serious side-effects including psychotic episodes and suicidal
thoughts in children taking Concerta, a brand-name form of
methylphenidate.
There have been numerous issues relating to ADHD medications in
2005;
In February 2005, Canada pulled
Adderall XR from pharmacy
shelves after Adderall manufacturer Shire provided information
about 20 sudden deaths in patients taking this popular ADHD
medication. Adderall is also linked to 12 strokes, two of which
occurred in children.
The FDA plans to strengthen Concerta warnings after finding that
Concerta can cause psychotic behavior and death.
Concerta and similar drug treatments for ADHD. A routine FDA
review of Concerta found that there have been dozens of reports of
hallucinations, violence, thoughts of suicide and death. Yes,
death. The FDA found 16 deaths from Concerta since the popular
drug was first introduced five years ago.
Strattera's Black Box labeling concerning
liver damage
warns that severe liver damage may progress to liver failure
resulting in death or the need for a liver transplant in a small
percentage of patients taking Strattera.
A study released February 2005 links
Ritalin to an increased cancer risk and other health
problems. Researchers of this startling study found that 1 out of
every 12 children using methylphenidate experienced a threefold
increase in levels of chromosome abnormalities, occurrences
associated with increased risks of cancer and other adverse health
effects.
The simple fact is that these medications have risks and some
of these risks are quite serious. It is our opinion that these
high-powered drugs should be a last resort instead of the first
course of treatment in addressing Attention Deficit Disorder.
There are viable options and alternatives to pharmaceutical
medications. Click
here
for information about effective, all-natural and non-prescription
supplements for Attention Deficit Disorder.
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