Colorado Cymbalta Lawyers
How Does Cymbalta work?
Cymbalta works by inhibiting the absorption of serotonin, norepinephrine, and dopamine, by the nerve cells in the brain. When these compounds are released, they put you in a better mood. Some believe that depression can be a result of decreased levels of serotonin and norepinephrine in the brain. The theory behind Cymbalta is that it prevents these compounds from being absorbed by the nerve cells, and therefore there would be more serotonin and norepinephrine in the brain. In theory this would prevent depression.
Suicide Related Warnings
On December 13, 2006, the FDA announced that antidepressants prescribed to young adults pose serious risk for suicide in teenagers and young adults. The FDA proposed expanding the labels of all antidepressants to include an expanded warning of a risk of suicidal thoughts in patients ranging from 18-24.
The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.
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Cymbalta News
FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants May 3, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately.
The FDA uses the term "suicidality" to describe what they call suicidal thinking and behavior. The new "black-box" label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18 to 24, during the initial stages of treatment, which usually encompasses the first couple of months.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
The updated warnings would, naturally, include several mitigating points as well. The new labels would stress the fact that the increased risk of suicidality has not been scientifically proven among patients older than 24, and also that patients older than 65 have actually been shown to have a decreased risk of suicidal thoughts and behavior when taking antidepressants. The warnings would also include language reminding consumers about the serious risks associated with untreated depression and other psychiatric disorders.
However, the FDA made it clear that the new warnings apply to "the entire category of antidepressants" and that available data "are not sufficient to exclude any single medication from the increased risk of suicidality."
The FDA mandated similar labeling changes to antidepressants in 2005, but those warnings were specific to the suicidality risk in children and adolescents only. Since that time, the FDA has attempted to ascertain the risk of suicidality in adults taking antidepressants by conducting comprehensive reviews of 295 individual antidepressant trials that included more than 77,000 adult patients with major psychiatric disorders. Five months ago, the FDA's Psychopharmacologic Drugs Advisory Committee recommended that the label warnings be updated to include young adults, but only now has the FDA taken any decisive action.
The drugs associated with the new label warnings are:
- Anafranil (clomipramine)
- Asendin (amoxapine)
- Aventyl (nortriptyline)
- Celexa (citalopram hydrobromide)
- Cymbalta (duloxetine)
- Desyrel (trazodone HCl)
- Elavil (amitriptyline)
- Effexor (venlafaxine HCl)
- Emsam (selegiline)
- Etrafon (perphenazine/amitriptyline)
- fluvoxamine maleate
- Lexapro (escitalopram hydrobromide)
- Limbitrol (chlordiazepoxide/amitriptyline)
- Ludiomil (maprotiline)
- Marplan (isocarboxazid)
- Nardil (phenelzine sulfate)
- nefazodone HCl
- Norpramin (desipramine HCl)
- Pamelor (nortriptyline)
- Parnate (tranylcypromine sulfate)
- Paxil (paroxetine HCl)
- Pexeva (paroxetine mesylate)
- Prozac (fluoxetine HCl)
- Remeron (mirtazapine)
- Sarafem (fluoxetine HCl)
- Seroquel (quetiapine)
- Sinequan (doxepin)
- Surmontil (trimipramine)
- Symbyax (olanzapine/fluoxetine)
- Tofranil (imipramine)
- Tofranil-PM (imipramine pamoate)
- Triavil (perphenazine/amitriptyline)
- Vivactil (protriptyline)
- Wellbutrin (bupropion HCl)
- Zoloft (sertraline HCl)
- Zyban (bupropion HCl)
FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
May 2, 2007 | www.fda.gov
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
Study shows pills raise suicide risk in young adults
Dec 14, 2006 | Washington Post
Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a federal analysis of hundreds of clinical trials. It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18.
Officials at the Food and Drug Administration said Wednesday that the higher risk was found in patients between 18 and 25 and that the risk faded among older patients. The finding comes two years after the agency ordered a "black box" warning on the drug labels after the discovery of a heightened risk of suicidal behavior among children taking the pills.
After reviewing the latest data, an expert federal panel on Wednesday recommended that agency officials tell doctors and the public of the risk but also find a way to note that the risk declines with age, and that leaving depression untreated also is risky.
While the studies on the relationship between the drugs and suicide appear contradictory, the experts said one possibility is that the drugs may pose a risk early in treatment but have a protective effect in the long term.
The agency is leaning toward expanding its black box warning, said Thomas Laughren, director of FDA's division of psychiatric drug products. Officials said they will try to craft language that would urge clinicians to use the drugs carefully, not abandon them.
The new finding created a dilemma for the regulators. Even as it vindicated some of what critics of drugs such as Prozac, Paxil and Zoloft have said for years, the earlier official warnings about the drugs appear to have led to a drop in their use and there are troubling signs that this can lead to an increase in suicides.
After concerns were raised in the Netherlands about the suicide risk, there was a 22 percent drop from 2003 to 2005 in antidepressant prescriptions for patients younger than 18 and a 50 percent increase in suicides, said Robert Gibbons, a professor of psychiatry at the University of Illinois in Chicago. The number of suicides went from 34 to 51.
"What we are seeing is the early signs of an epidemic of suicide in children who are no longer being treated for their depression," Gibbons said in an interview. U.S. suicide data for 2005 is not yet available, but Gibbons said the FDA's black box warning had caused a similar decline in prescriptions among children here. He predicted dozens of additional suicides as a result and warned that any expansion of the black box would have a similar impact on adults.
Robert Temple, director of FDA's Office of Medical Policy, said regulators were in a bind. On the one hand, they need to tell physicians about the new results in order to warn them to monitor patients closely for suicidal behavior, but if that means doctors stop prescribing the drugs altogether, "I don't know what you are supposed to do."
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