Strattera Linked to Suicidal Thoughts in Children
Strattera Linked to Suicidal Thoughts in Children
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.
The FDA is now making the company put a warning label on its
product about the Strattera/child suicide connection. This
newest warning, released Sept. 29 2005, is the result of
re-analzed 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.
About 3.4 million people have used Strattera since it became
available in 2003. Of those, about 75 percent are children.Lilly
issued its first Black Box warning - the strongest warning that
can be attached to a prescription medication - in 2004 when
studies showed the Strattera caused detrimental effects on the
liver.
At the FDA's request, Lilly will add the "Black Box" warning
about suicidal thoughts, as well as 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.
There have been numerous other 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 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.
The simple fact is that ADHD medications have risks and some of
these risks are quite serious. It is a growing 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.
These alternatives include diet modifications, increased
exercise - especialy outdoors exercise, talk therapy,
biofeedback, life coaching and nutritional supplementation.