Considering the Food and Drug Administration (FDA) has been fumbling
the "safety ball" a lot lately, people, including the
media, have begun paying closer attention to what the agency is
doing ... or rather, not doing.
That could be why the FDA has been putting forth extra effort in
its safety evaluation of drugs already on the market. Case in point:
During a meeting of the FDA's Pediatric Advisory Committee, officials
discussed adding new warnings to Concerta and other attention deficit
and hyperactivity drugs containing methylphenidate (the active ingredient
in Ritalin and other drugs).
According to a briefing document about
the meeting, the review was prompted by reports of:
- Hallucinations
- Suicidal thoughts
- Psychotic behavior
- Aggression
And while Concerta's label already lists possible psychiatric side
effects, it merely suggests the problems aren't serious or that
the drug may only magnify already existing problems.
Other harmful effects associated with Concerta, per reports received
by the FDA, include cardiovascular problems such as high blood pressure,
arrhythmia and racing heartbeats; however, the FDA is unsure whether
these effects are caused by the drug. (Let's hope not, considering
patients filled 7.8 million prescriptions of Concerta just last
year.)
The FDA plans to examine other stimulants used to treat ADHD, such
as amphetamines and Straterra.
USA
Today June 30, 2005
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