QUEENSBURY, N.Y. -- It strikes Kate Miller as odd that the FDA
will tell people to stop eating tomatoes suspected of causing
illness, but it doesn't pull a drug off the shelves that might make
people suicidal.
"If it was a tomato or pepper or dog food, they would have been
blasting it all over the media," Miller said.
Miller son's Cody, 15, killed himself last summer, 17 days after
he started taking Singulair for allergies. The Millers believe
Cody's swift transformation from happy to anxious is linked to the
drug, though a recent study raised doubt about the connection.
Miller is frustrated that while the federal Food and Drug
Administration investigates Singulair and other drugs suspected of
causing suicidal behavior, ads for Singulair appear on TV with no
mention of mood-changing side effects. The Millers are getting
calls from families across the country whose loved ones have
experienced emotional problems and suicides they believe are linked
to the drug.
But a study released earlier this month by the American Lung
Association runs contrary to the beliefs held by the Millers and
other families. Researchers reviewed the cases of 1,352 patients
enrolled in ALA clinical trials for montelukast, the compound in
Singulair. Of the 536 patients treated with montelukast, there was
no evidence of depression or suicide linked to the drug, according
to the association.
Miller criticized the study because she said it was too small.
She's waiting for the FDA study, which is looking at more than
11,000 people who participated in clinical trials for Singulair.
The review should be done later this year.
"The FDA is still completing its ongoing evaluations and as
soon as the review is complete, the FDA will communicate its
conclusions and recommendations to the public," said Christopher
Kelly, a spokesman for the agency, in an e-mail. "As per the Early
Communication issued in March, the FDA continues to advise
healthcare professionals and caregivers to monitor patients taking
Singulair for suicidal thinking and behavior, and changes in
behavior and mood."
The March notification, which was distributed to physicians and
pharmacists, said the agency "is working with Merck to further
evaluate a possible link between the use of Singulair and
behavior/mood changes, suicidality and suicide in response to
inquiries received by FDA."
The notification advised patients not to stop taking Singulair
before talking to their doctor.
"You get a one-day blurb about children that might have mood
and behavior disorders and suicidal thoughts and then it's shuffled
under the rug," Miller said.
Miller doesn't want Singulair, a popular treatment for asthma
and allergies, taken off the shelves. She wants doctors, patients
and parents to be watchful for mood changes when someone begins
taking the drug. From what she is hearing, Miller says doctors and
patients still don't know about the potential side effects.
Merck & Co., the maker of Singulair, added depression (April
2007), suicidal thinking and behavior (October 2007), and
anxiousness (February 2008) to the list of the drug's possible side
effects. The information is in the lengthy information booklet that
accompanies the drug.
Merck has acknowledged that the drug crosses the blood brain
barrier. The barrier is a semi-permeable tissue in the brain that
prevents foreign substances from entering the brain. In studies of
rats, a minimal amount of the drug crossed the barrier, according
to information on the Merck Web site.
The FDA instructed Merck to educate doctors about the
mood-changing side-effects in one-on-one meetings with the doctors,
a task usually handled by sales people.
If the doctors have questions, Merck provides them with the FDA
notification and a statement from the company about the label
change.
"If they have additional questions, they can call the company
and talk with a Merck physician," said Ron Rogers, a Merck
spokesman.
Rogers said Merck continues to cooperate with the FDA's
investigation.
Robert Baker, director of Union Graduate College's bioethics
program in Schenectady, N.Y., who was critical of Merck for
withholding negative information about its cholesterol drug
Vytorin, said the FDA has acted properly by collecting information,
releasing a notice to doctors, pharmacists and the public, and
studying the issue further.
"One of the reasons the FDA hasn't done anything is that he FDA
needs data to do anything and the data suggests that there is no
real correlation," he said, referring to the American Lung
Association Study. "I'm always delighted to criticize the
authorities but I don't see anything here to criticize."
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(E-mail: ccrowley@timesunion.com.)
c.2008 Albany Times Union