Studies on ADHD Drugs Get Attention

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Studies on ADHD drugs get attention

Doctors urge caution when using medication

Renewed concerns about the potentially deadly side effects of
stimulants such as Ritalin have left some local doctors undaunted.

Last month, a federal advisory panel recommended the Food and Drug
Administration affix black box warning labels to the drugs commonly
used to treat attention deficit hyperactivity disorder because of
potential cardiovascular and psychiatric risks.

Making matters murkier, another federal advisory panel two weeks ago
disagreed, saying drugs for attention deficit hyperactivity disorder
should not have to carry the government's strongest warning.

Instead of having the "black-box" warnings, the drug labels should
caution users about possible dangers in plain language they can
understand, the FDA pediatric advisory committee said. The FDA is
expected to follow the latest recommendations.

Debra Wertz of Ridgeland believes calls for requiring a "black box
warning" on the drugs are premature.

"I haven't seen enough hard evidence linking those type drugs to
cardiovascular diseases," said Wertz whose 14-year-old son, Zach, takes
Concerta for ADHD.

ADHD is one of the most common mental disorders that develops in young
children.

Before her son was placed on the medication, Wertz had an EKG test
performed on his heart.

"I just wanted to be sure, but the doctor kept telling me it wasn't
necessary. But I insisted."

The FDA's Drug Safety and Risk Management advisory committee panels'
recommendations last month stemmed from reports showing 25 children and
adults had died between 1999 and 2003 while being treated with the
medications.

The deaths and other reported side effects of the medications are
unfortunate, but do not signal alarm, said Dr. Susan Buttross, chief of
the Division of Child Development and professor of pediatrics at the
University of Mississippi Medical Center.

"This is information that we have always known - any medicine should be
taken with precaution," she said. "One thing that I always tell parents
is if they believe that these medicines are causing side effects, they
need to certainly contact their physician."

Buttross said she will continue to prescribe the drugs.

The medications that caught the advisory board's attention are
methylphenidates, which are sold as Ritalin, Concerta, Methylin and
Metadate.

"Before I put a child on medicine, I do a physical and medical exam to
make sure there's not a history of cardiovascular problems.
Occasionally you will have a child with a slightly increased blood
pressure, but I have never had a child with a cardiac incident from the
medication," she said.

Steven Nissen, a drug safety and risk management advisory committee
member, says many of the 4 million people who use the drugs may not
realize they have serious side effects.

"I want parents and doctors, before they prescribe amphetamines and
amphetamine-like drugs to children, to think a little harder (about)
whether they need them," says Nissen, interim chairman of the Cleveland
Clinic's department of cardiovascular medicine.

Wertz said her son's medicine has changed their lives for the better.

"These are not people with character flaws. They have illnesses just
like heart disease or diabetes. It's real," she said. "We went through
all the other medications - Ritalin, Adderall, Dexedrine - but once we
got him on Concerta, his behavior changed totally. He started making
good grades. Before he was on the medication, he was failing in
school."

In 2004, the FDA placed warnings on the stimulants Adderall and
Adderall XR after the drugs were associated with some deaths.

However, Dr. Richard Ogletree does not think this recent recommendation
will be accepted by the FDA. Ogletree is a pharmacist and coordinator
of the Drug Information Center at UMC.

" The drug safety people are primarily wanting to make sure there
aren't going to be any problems with the drugs, whereas psychiatric
people are looking at whether they can (prescribe) these drugs," he
said. "Some of the concern with the major warning is that it might
prevent people who could actually benefit from these drugs from getting
them."

During his visits to various pharmacies, Ogletree says he has not seen
many complaints about severe cardiac events as a result of using the
medications.

Ogletree said he would be interested in further studies that show
whether the drugs alone are to blame for cardiovascular problems. He
said their increasing use among adult patients has changed the
statistical reports.

"Until recently, they were used in younger people who were at lower
risk for cardiac events. Now we have more older people - is (death)
because of the drugs or because of something else," he said. "These are
concerns when we have a newer population and we don't have data about
the longterm outcome."