CYMBALTA: Five Patients Commit Suicide During Clinical Trials: U.S.A.

NOTE FROM Ann Blake-Tracy (www.drugawareness.org):
So even though 19 year old bible college student, Tracy Johnson’s, suicide was the only one we heard about happening in the clinical trials with Cymbalta (taking place within Lilly’s own laboratory in a “healthy volunteer”), there were apparently FOUR MORE SUICIDES in the clinical trials?!!
Paragraphs five &  six read: “While people say many of Cymbalta’s side effects are manageable, some users experience effects that are extremely frightening and potentially dangerous. Some patients found the drug tends to trigger heart palpitations and increase anxiety levels and elevate the severity suicidal thoughts or impulses.”

“A 19-year-old college student who had shown no outward signs of depression killed herself at an Eli Lilly & Company laboratory in Indianapolis where she had been participating in a company drug trial for the experimental antidepressant. Four other patients who were given the drug during earlier trials also committed suicide.”

ADDITIONAL COMMENT BY Ann Blake-Tracy: HOW LONG ARE THEY GOING TO BEAT THIS RIDICULOUS HYPOTHESIS TO DEATH WHEN THERE IS ABSOLUTELY NO EVIDENCE, NOR HAS THERE EVER BEEN, THAT THE SSRI ANTIDEPRESSANTS DO THIS AND MOST ESPECIALLY THERE IS NO EVIDENCE THAT THEY “RESTORE BALANCE TO THE EMOTIONS”??????!!!!!!

I QUOTE ONCE AGAIN THE NEVER ENDING SEROTONIN LIE: “The drug works by preventing serotonin and noradrenaline from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood-lightening effect of any released serotonin and noradrenaline, restoring balance to the emotions of the patient.”

http://www.emaxhealth.com/1357/25/33042/cymbalta-side-effects.html

Submitted by Tyler Woods Ph.D. on Aug 22nd, 2009
Posted under:

Cymbalta, generic name Duloxetine Hydrochloride, has certain side effects consumers should be aware of.

Cymbalta manufactured by Eli Lilly is a serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant used to treat major depression. It is prescribed to treat pain associated with diabetic peripheral neuropathy, which is a painful nerve disorder associated with diabetes that affects the hands, legs, and feet. Cymbalta has only recently been approved for use to treat fibromyalgia if people can tolerate Cymbalta’s side effects.

The drug works by preventing serotonin and noradrenaline from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood-lightening effect of any released serotonin and noradrenaline, restoring balance to the emotions of the patient. Cymbalta may also be used in the treatment of generalized anxiety disorder.

Among the more common Cymbalta side effects that users complain about is being fatigued even after a good night’s sleep. Blurred vision, dry mouth, nausea, vomiting, and issues with both constipation and diarrhea, agitation, irritability, increased, hostility, high blood pressure, decreased libido, hot flashes, fatigue, rash, and increased sweating have also been reported.

While people say many of Cymbalta’s side effects are manageable, some users experience effects that are extremely frightening and potentially dangerous. Some patients found the drug tends to trigger heart palpitations and increase anxiety levels and elevate the severity suicidal thoughts or impulses.

A 19-year-old college student who had shown no outward signs of depression killed herself at an Eli Lilly & Company laboratory in Indianapolis where she had been participating in a company drug trial for the experimental antidepressant. Four other patients who were given the drug during earlier trials also committed suicide.

Anyone taking Cymbalta should understand that they can be at risk while driving, handling machines, or performing other hazardous activities such as working on tall ladders as it can cause dizziness or drowsiness.

Many people report that there were no Cymbalta side effects except for a lowered sexual drive and feel the drug gave them back their life. Like other antidepressants, Cymbalta should not be stopped suddenly if you have been on it for some time. Your brain receptors will adjust to it, and suddenly stopping can cause crying jags, agitation, dizziness, nausea, or headache. You should always talk with your doctor or healthcare provider to work out a plan to slowly decrease your medication to avoid withdrawal symptoms.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit

www.fda.gov/medwatch, or call 1-800-FDA-1088.

References
New York Times
Drugs.com
Source:
Tyler Woods Ph.D.

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10/09/2000 – Congressman attributes son’s suicide to Accutane

msnbc.com

Lawmaker tells of acne drug’s risk

Rep. Bart Stupak.

NBC’s Dr. Bob Arnot discusses the possible health risks of Accutane and
alternative treatments for severe cases of acne.

Congressman attributes
son’s suicide to Accutane

MSNBC STAFF AND WIRE REPORTS

TRAVERSE CITY, Mich., Oct. 5. A Michigan congressman whose
17-year-old son committed suicide earlier this year went public Thursday with
criticism of the Food and Drug Administration, charging on NBC’s Today
show that the agency had failed to warn consumers that the popular acne
medicine Accutane may cause depression.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that. REP. BART STUPAK

BART STUPAK JR., known as B.J., shot himself in the head with his
father’s gun in the early hours of May 14. Stupak, a popular football player,
killed himself after a prom-night party.

His father, Rep. Bart Stupak, a four-term Democrat from Menominee,
said Thursday that he blames Accutane, a powerful acne drug B.J. had taken
for six months prior to his death. We knew our son, we loved our son, he
said.

The congressman and his wife, Laurie, said they had considered every
possible explanation for B.J.’s suicide and the only thing we can find is
Accutane.

FDA ADVISORY

In 1998, the Food and Drug Administration advised doctors who
prescribe Accutane to watch their patients for signs of depression.
Afterward, the company notified doctors that the drug may cause depression,
psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.

But Stupak said the FDA had done a poor job spreading the word. B.J.’s
medication package included no warning and the doctor didn’t tell the parents
about the link to depression, his father said.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that, Stupak said.

Hoffmann-La Roche, which manufactures Accutane, contends no
link has been proven between the drug and depression or suicide. In 1998, the
company argued that more than 4 million Americans have taken Accutane since
it was approved in 1982, and the possible side effect is very rare. It said
teen-agers, prime acne sufferers, often suffer depression, and hormones
involved with acne also may contribute to depression.

B.J.’s death stunned family and friends. In the Today interview,
his parents said he was a happy young man with a bright future.

COMPLETELY OUT OF CHARACTER

This is contrary to everything he lived for, everything he thought,
everything he wanted in life … completely out of character for him, Stupak
said. He would not do something like this.

B.J. left no note and the autopsy showed no drugs in his system,
although he apparently had taken a couple of drinks.
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The only suggestion of odd behavior came the night before his death.
During a party following his junior prom, B.J. began reading the Bible and
said he wasn’t going to college because of his grades, and that his parents
probably hated him for that, according to an account on the Today program.
The Stupaks said there was no reason for him to think such a thing.

An FDA science advisory panel last month suggested requiring
Hoffman-LaRoche to give patients information about potential risks, agency
drug chief Janet Woodcock said.

INSUFFICIENT DATA

But Woodcock said there still was insufficient data to establish a
definite connection between Accutane and depression or suicide.

It’s really hard to nail this down, she said in a telephone
interview Wednesday. The bottom line is there is evidence against there
being a link and evidence for being a link.

During the advisory panel meeting, FDA staffers presented evidence
that some people had become depressed when taking the drug and had gotten
over their depression after stopping use of the drug, Woodcock said.

But experts for Hoffman-LaRoche countered with evidence suggesting no
link, she said. The committee recommended further study.

The Associated Press contributed to this report.

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