Remeron (Mirtazapine) Serious blood and bone marrow abnormalities & liver problems

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Remeron, also known as mirtazapine, is indicated

for the treatment of mental depression.

Signs of depression include a depressed mood, weight change, insomnia, fatigue,

agitation, suicidal tendencies, feelings of guilt and loss of interest

in activities. Remeron comes as a tablet to take by mouth once a day.

Approved by the U.S. Food and Drug Administration (FDA) in 1996,

Remeron is made by Organon.

Potential side effects of Remeron include, but may not be limited

to, drowsiness, dizziness,

anxiousness, constipation,

upset stomach, vomiting, confusion and dry mouth.

Remeron has been linked to numerous adverse reactions. The Federal

Government's Adverse Drug Reactions Advisory Committee has received

dozens of reports involving serious blood and bone

marrow abnormalities. Remeron has been linked to liver problems

and hallucinations.

In October 2003, the FDA notified healthcare professionals of

reports of the occurrence of

suicidality (both suicidal ideation and suicide attempts) in clinical

trials

for various antidepressant drugs in pediatric patients with major

depressive

disorder (MDD). FDA has completed a preliminary review of such reports

for 8

antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine,

nefazodone, paroxetine, sertraline, and venlafaxine) studied under the

pediatric exclusivity provision, and has determined that additional

data and

analysis, and also a public discussion of available data, are needed.

In March 2004, the Food and Drug Administration issued a Public

Health

Advisory that provides further cautions to physicians, their patients,

and families and caregivers of patients about the need to closely

monitor both adults and children with depression, especially at the

beginning of treatment, or when the doses are changed with either an

increase or decrease in the dose.

FDA is asking manufacturers to change the labels of ten drugs to

include stronger cautions and warnings about the need to monitor

patients for the worsening of depression and the emergence of suicidal

ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine,

fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline,

escitalopram and venlafaxine. It should be noted that the only drug

that has received approval for use in children with major depressive

disorder is fluoxetine (Prozac). Several of these drugs are approved

for the treatment of obsessive-compulsive disorder in pediatric

patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and

fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the

United States.

See your doctor if you have experienced serious health problems

after receiving Remeron. In addition, it may be important to contact an

attorney who can help you protect your legal rights. Please keep in

mind that there may be time limits

within which you must commence suit.

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