FDA Fails to Warn Public About Suicide Risks Associated With Singulair

15-year-old
Cody
Miller received a prescription for Singulair
in the Summer of 2007 to treat an allergy
problem. Despite having no history of emotional
problems, he hanged himself in his parent’s Queensbury, New
York home two weeks after he began taking Singulair.
The perplexing question that arose from such a tragedy is what could
have triggered Cody’s unexpected decision.

That
is a question that Merck,
the manufacturer of Singulair, may have answered when just two months
later, it reported that some Singulair
(PDF) patients had experienced “behavior and mood related changes
[agitation including aggressive behavior, bad/vivid dreams,
depression, feeling anxious, hallucinations (seeing things that are
not there), irritability, restlessness, suicidal
thoughts and actions (including suicide), tremor, trouble
sleeping]”. This information could have been useful for Cody’s
parents when they began to notice Cody’s unusually moody
and anxious behavior.

Kate
Miller, Cody’s mother, stated that Merck and the FDA
should have warned parents more forcefully by taking a more assertive
role to reveal the information. Had she known of the information
earlier, she would have never permitted her son to take Singulair.

In
a similarly disturbing incident, Douglas Briggs, a 54-year-old
doctor, was prescribed Neurontin,
an epilepsy
drug that is also prescribed for nerve-related pain associated with
chronic back trouble, after injuring his back in a car crash. A few
months later, on Christmas Day, he insisted that his family go see a
movie because he wanted to be alone.

When
his family returned, they found Douglas hanging lifeless. Douglas’s
family had noticed a sudden behavior change prior to the incident.
His son Andrew Briggs stated that, “[his father] started developing
uncharacteristic mood swings and irritability.” Andrew also said
that his father “began talking about losing the desire to practice
medicine, even though it was a great passion of his.” While
Douglas Briggs’ family was concerned, they failed to make at what
at the time seemed a far attenuated connection.

Pfizer,
the manufacturer of the drug, claims that there is “no evidence to
support the claim that Neurontin causes an increased risk of
suicide-related events.” However, the company’s original
prescribing literature contained rare reports of suicidal gestures.
Today there are over 250 lawsuits pending, filed by families who have
suffered similar losses.

An
advisory panel convened this past summer to evaluate Neurontin along
with ten other epilepsy drugs. The finding? “The effect appears
consistent…” Epilepsy drugs are associated with a higher risk of
suicidal thoughts or behavior. While the panel accepted the FDA’s
findings, it voted against imposing the government’s strongest
warning on the drugs. Dr. Thomas Laughren, the head of the FDA’s
division of psychiatric products stated that “[e]ven though a drug
is identified as a drug for weight control, or smoking cessation, or
asthma, these drugs often also get into the brain, so there is always
the potential for having psychiatric side effects.”

These
tragic incidents bear a direct correlation to the FDA and other
pharmaceutical companies’ failure to adequately warn people like Cody
and Douglas of the side-effects before placing these drugs on the
market. Companies such as Merck and Pfizer continue to earn
increasing profits while others suffer from their shameless
practices. The FDA should make a concerted effort to prevent future
incidents by informing patients of essential information, including
but not limited to side-effects, in a timely and responsible manner.