should carry heart attack warning, US scientists recommend
by Mike George
drugs such as Ritalin should carry a prominent warning that they
can increase the risk of heart attacks, US scientists have recommended.
US Food and Drug Administration (FDA) report said, since 1999, there
has been 51 deaths in the US among children and adults taking methylphenidate
and amphetamine drugs for ADHD (attention deficit hyperactivity
FDA report also detailed 54 cases of serious cardiovascular problems,
including heart attack, stroke, hypertension, palpitations and arrhythmia,
in adults and children being treated with ADHD drugs.
the US, 2m prescriptions for ADHD drugs for children are made every
month and 1m for adults.
FDA's Drug Safety and Risk Management advisory committee is reviewing
ways to study whether the deaths are linked to use of the drugs.
The few studies that have looked at longer-term use of ADHD drugs
provide little information on those risks, the FDA said.
recommendation last week by an advisory panel of the FDA is to put
a "black box" warning on all ADHD drugs in the US. The
recommendation is likely to be accepted.
There is likely to be pressure on the UK’s Medicines and Healthcare
Products Regulatory Agency (MHRA) to issue a similar warning.
confirmed that - according to its adverse drugs reaction monitoring
system - nine UK children on methylphenidate have died.
Prescribing of ADHD drugs has soared in recent years. In the UK,
361,832 prescriptions were written last year for Ritalin and other
drugs of the methylphenidate class, such as Concerta and Equasym.
It is not known exactly how many UK children have been diagnosed
MHRA said the cause of death for two of the nine children who died
in the UK was heart-related: one had a heart attack and a second
an enlarged heart.
One was recorded as a "sudden death". One died of a haemorrhage
in the brain and another of a swelling in the brain, two committed
suicide and the last died of neonatal respiratory distress syndrome
– as the mother was probably on the drugs.
The MHRA emphasised that the recording of such deaths did not necessarily
mean the drug caused the death.
FDA advisers said it was not certain the drugs contributed to the
51 deaths. "The data is only suggestive at this point, but
because of the gravity of the side-effect, namely sudden death,
physicians need to be made clearly aware of that concern,"
said Dr Peter Gross, the panel chairman and head of internal medicine
at Hackensack University Medical Centre in New Jersey.
One member of the panel hoped the warning might slow down the soaring
rate of prescription of the drugs to hyperactive, poorly behaved
children. "I want to get people's hands to tremble a little
bit before they write that [prescription]," said Steven Nissen,
The MHRA said, since 1963, there had been 521 reports of suspected
adverse drug reactions from methylphenidate. But most of them have
been in the past five years as more children have been put on them.
A MHRA spokeswoman said the MHRA “will constantly look carefully
at the risk-benefit structures of medicines."
Feb 14: Disordered thinking?
- the prescribing of ADHD drugs is soaring, while concerns are escalating
about dangerous side effects. Is it time the social and family lives
of ADHD-diagnosed children are examined as much as their brains,
asks Adam James
31, 2006: Prescribing of drugs to treat ADHD children doubled in
six years - figures revealed by National Institute for Health
and Clinical Excellence as it starts work on ADHD clinical guidelines
do you think? Email your comments on the above
article to the editor using the form below. Selected comments will
© 2001-7 Psychminded Limited. All
about this article