MORE BAD NEWS ON RITALIN!!!! MAYBE THIS GUY IS ON IT????

Picture 046, originally uploaded by Oldmaison.

Tacoma, WA - February 21, 2006


Welcome, Guest
Log in | Sign up! Bigger text Smaller text E-mail this story Print this story Text only

New: Add or view comments to this story; 0 Comments

British report finds new risks of ADHD drug

M. ALEXANDER OTTO; The News Tribune
Published: February 20th, 2006 02:30 AM





There are new safety concerns about the Attention Deficit Hyperactivity Disorder drug Strattera, widely used in Europe and the United States. It’s already been linked to rare cases of liver damage and suicidal thoughts and behaviors.


British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002.

The warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency, the United Kingdom’s equivalent to the U.S. Food and Drug Administration.

The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released to a drug-safety activist in that country.

Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and warned doctors and consumers Thursday that the drug should be used with caution in people prone to such problems. In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.

British authorities are updating the drug’s label in that country to warn of the possible problems.

Overall, though, the agency concluded Strattera still offers more benefits than risks.

Though the FDA and Strattera’s maker, Indianapolis-based pharmaceutical giant Eli Lilly, are aware of the issues raised by the British, they are being handled differently in this country.

No warnings are planned at the moment to U.S. doctors and patients, and the U.S. label for Strattera contains no warning of seizures.

At the FDA’s request, Lilly inserted a five-word note about the “very rare” heart problem on page 17 of the drug’s 25-page label in January.

The reason there is less concern on this side of the Atlantic ocean is that, unlike the British agency, Lilly “hasn’t been convinced” that the problems aren’t caused by underlying illnesses, said Dr. Albert Allen, Lilly’s medical director for Strattera, which earned the company about $400 million in 2005.

Europeans, Allen noted, are more skeptical of ADHD diagnoses and so are more quick to sound the alarm about potential ADHD drug problems.

ADHD is suspected when people have a harder time than others their ages paying attention, sitting still or controlling impulses. To be diagnosed, those tendencies must interfere with work, school or other activities.

Skeptics say the condition is overdiagnosed and that drugs are used to subdue normal, but often disruptive, rambunctiousness in the classroom and workplace.

The Strattera report comes at a time when the FDA is scrutinizing the safety of all ADHD drugs, including some associated with significant mental and physical side effects.

On Feb. 9, an FDA panel advised that Ritalin, Concerta and other stimulant ADHD drugs include a strong warning of the possibility of heart attacks, strokes and sudden death. Strattera is not a stimulant and wasn’t included in the recommendation.

In March, the panel will reconvene to consider the drug’s psychiatric side effects.

The British findings “will be another factor in FDA’s” review of the drugs, said agency spokeswoman Susan Kruzan.

British investigators found 220 seizure reports among Strattera users through May 2005, which makes seizures “the most commonly reported serious” safety problem.

The red flag the British raised is based mostly on the four seizure reports that could not be convincingly pinned on underlying medical problems. Patients in those cases had no prior seizure history.

The agency noted, though, “there’s a number of reports” in which the drug is associated with an aggravation of pre-existing seizure disorders.

There have been 33 cases reported of the heart-ryhthm problem. The possible role of Strattera in at least seven “could not be excluded,” the report said.

“No other alternative causes could be identified” in two cases where patients took normal doses; one case was related to an overdose.

Fifteen patients with the heart-rhythm problem recovered after stopping the drug, the report noted. The heart issue seemed most likely when the drug is taken with antidepressants, which restrict the body’s ability to break down Strattera.

British authorities also found 130 cases of potentially severe liver problems whose relationship to Strattera “could not be completely ruled out.”

The 431 reports of suicidal thinking or behavior could not be clearly linked to the drug because patients had histories of depression and other problems.

But “one cannot exclude the possibility that (Strattera) may have exacerbated the individual’s underlying condition,” the report noted.

Strattera’s label was updated last fall in Europe and the United States to warn of rare suicidal behavior risks.

Strattera, the only ADHD drug that is not a stimulant, typically is used as an alternative to drugs like Ritalin, which have been on the market much longer and whose safety records are more clearly known, said Dr. Brian King, director of Child and Adolescent Psychiatry at Children’s Hospital and Medical Center in Seattle.

Strattera offers two advantages: as a nonstimulant, it has no abuse potential, plus it stays in the body for a few hours longer, so ADHD control is extended into the evening if necessary, Allen said.

More online

Strattera’s label is at www.strattera.com/hcp/1-0_strat tera_homepage.jsp under “full-prescribing information.”

The British Strattera report is at www.thenewstribune.com/documents/news/ strattera_report.pdf.

M. Alexander Otto: 253-597-8616

alex.otto@thenewstribune.com