FDA Warnings

[scotty]

Increased risk of suicide in children and teens

http://www.fda.gov/cder/drug/antidep...IPHA200410.htm

Increased risk of birth defects and pulmonary hypertension

http://www.paxilprogress.org/forums/...ad.php?t=17284
http://www.fda.gov/cder/drug/advisor...tine200512.htm

Increased suicidality in Adults

http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

[Bern]

bump

[scotty]

These are in a new permanent home at the top of this page!!! No need to bump, but thanks for the thought!!

[mach3939]

Originally Posted by scotty

These are in a new permanent home at the top of this page!!! No need to bump, but thanks for the thought!!

Laurie you may have to fix this cause it is not at the top of the page?

Debbie

[scotty]

Look about the forum postings!!! There are 6 permanent threads up there.. not within the message board, above it!

[mach3939]

Laurie I think something is wrong when I click on the general discussion page Help with husbands rage is #3, there are only 2 with thumbtacks on mine? Are you seeing it different?

Debbie

[scotty]

LOL!! Look up higher. Off the green box with the posts in it.

[mach3939]

OK same thing? In the green boxes and above. I dont get it but you can delete these posts if you want. Yep I am still brain dead thing!

Debbie

[scotty]

OK...Look up higher

You'll see Adverse Drug Reaction reporting FDA warnings Paxil Protest Petition etc..

Those words are now links to permanent threads. The thread that we are posting in now will slowly dissappear off the front page.

[scotty]

Does this help? It's small, but you can see the area in question underlined in red.

[mach3939]

Yes, but I was clicking in the body of the page and it was there too! I understand that it is at the top now too? So This page is both at the top and in the postings!

Debbie

[scotty]

OK, now I understand the confusion. This thread has to stay for that one to be active. We create them here and then Darcy permanently puts them up on top. If we delete this one, the one on top deletes also. So this is unstickied and will just fall off the page if no one posts on it.

[mach3939]

Ok it is at both places then! That is why in the beginning I didn't understand that the thumbtack was missing it has been there for ages? You can delete what you and I posted talking about it?

Sorry
Debbie

[scotty]

No need to delete!!! I'm sure others are just as confused!!!

[LossLeader]

Yep.

Got it now, though.

[altostrata]

Just a suggestion for list managers:

Since the 6 permanent links can be accessed from all forum areas and are, in effect "ubertopics," move them up above the label for the forum area.

For example, move the "General Discussion" label down and the ubertopics up on the page.

That way, the spatial organization shows "these topics apply to all."

(This type of design is what I do for a living.)

[Amy Hall]

Am taking celexa and want to stop

[Homerbcool]

amy hall...welcome to paxilprogress...i am sur you have already witnessed some of compassion nd passion on the site..i am going t start a new thread under the general discusion forum..this way more people will be able to see and offer advice..

[Amy Hall]

THanks alot!!

[Amy Hall]

after aneurysm I don't know if I can take the brain shock

[altostrata]

This article was just published for continuing medical education (CME), which is required of all medical practitioners. Your doctor can get CME credits for reading it.

http://www.medscape.com/viewarticle/548176_print

--------------------------------------
Medscape Medical News
FDA Safety Changes: Paxil and Paxil CR CME/CE

News Author: Yael Waknine
CME Author: Yael Waknine

Complete author affiliations and disclosures, and other CME information, are available at the end of this activity.

Release Date: November 22, 2006; Valid for credit through November 22, 2007

Credits Available
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™ for physicians;
Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians;
Nurses - 0.3 nursing contact hours (0.3 contact hours are in the area of pharmacology)

All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation.

Physicians should only claim credit commensurate with the extent of their participation in the activity.

This activity is part of an ongoing CME/CE initiative to provide information on label changes reported by the FDA. Activities of this nature will be posted by Medscape on a weekly basis.

November 22, 2006 — On August 22, the FDA approved safety labeling revisions for paroxetine HCl tablets/oral suspension and controlled-release tablets (Paxil and Paxil CR, made by GlaxoSmithKline). Paroxetine is approved only for use in adults. The tablet and oral solution formulations are indicated for the treatment of major depressive, obsessive-compulsive, panic, social anxiety, generalized anxiety, and posttraumatic stress disorders. Paroxetine extended-release tablets may be used in the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder.

Use of Paroxetine (Paxil, Paxil CR) in Late Pregnancy Linked to Risk for PPHN in Newborns

The FDA has approved safety labeling changes to warn of potential risks associated with both continuation and discontinuation of paroxetine HCl therapy during pregnancy.

Data from a retrospective case-control study of 1213 women suggests that continued use of selective serotonin reuptake inhibitors (SSRIs) past the 20th week of pregnancy is linked to a 6-fold increased risk for persistent pulmonary hypertension (PPHN) in newborns. PPHN normally occurs in 1 or 2 per 1000 births and often involves severe respiratory tract failure requiring immediate treatment.

The FDA notes that although the study was too small to compare individual drugs and the risk has thus far not been investigated by other studies, the potential risk for PPHN adds to growing concerns regarding use of SSRIs during pregnancy.

Newborn adverse events previously reported in association with prenatal exposure include irritability, difficulty feeding, and rare cases of difficulty breathing. In addition, use of paroxetine during the first trimester has been epidemiologically linked to an increased risk for cardiac birth defects.

Women receiving antidepressant therapy who are pregnant or considering becoming pregnant should consult with their healthcare professional prior to discontinuing or continuing antidepressant therapy. Such a decision should be made only after careful consideration of individual treatment-related risks and benefits.

The FDA notes that patients who elect to discontinue SSRI therapy should be closely monitored for depression relapse. According to results from a prospective longitudinal study of 201 women, those who discontinue antidepressant therapy are 5 times more likely to have a relapse during pregnancy compared with those who continue treatment.

Concomitant Use of Paroxetine (Paxil, Paxil CR) and Triptans Linked to Risk for Serotonin Syndrome

The FDA has approved safety labeling changes to advise that concomitant use of selective serotonin reuptake inhibitors (SSRIs), such as paroxetine HCl, with serotonergic drugs (including 5-hydroxytryptamine-receptor agonists [triptans]) or drugs that impair serotonin metabolism (including monoamine oxidase inhibitors [MAOIs]), yields an additive effect on serotonin levels that can lead to potentially life-threatening serotonin syndrome.

Concurrent treatment with paroxetine and MAOIs is therefore contraindicated. Concomitant use of other SSRIs, serotonin/norepinephrine reuptake inhibitors, or the serotonin precursor tryptophan is not recommended. Caution is advised when using paroxetine in combination with other drugs or agents that can affect serotonergic neurotransmitter systems, such as the antibiotic linezolid (a reversible nonselective MAOI), lithium, tramadol, St. John's Wort, and triptans.

According to the FDA, rare postmarketing cases of serotonin syndrome have been reported with use of SSRIs and triptans. Potential symptoms include changes in mental status (eg, agitation, hallucinations, and coma), autonomic instability (eg, tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (eg, hyperreflexia and incoordination), and/or gastrointestinal tract symptoms, such as nausea, vomiting, and diarrhea.

Careful monitoring is advised for paroxetine-treated patients for whom concomitant triptan therapy is clinically warranted, particularly during initiation of therapy, dose increases, or the addition of another serotonergic drug.

Triptans are used to treat migraines. The drug class includes naratriptan HCl (Amerge, made by GlaxoSmithKline), almotriptan malate (Axert, made by Ortho-McNeil Pharmaceutical, Inc), frovatriptan succinate (Frova, made by Endo Pharmaceuticals), sumatriptan/sumatriptan succinate (Imitrex, made by GlaxoSmithKline), rizatriptan benzoate (Maxalt and Maxalt-MLT, made by Merck and Co, Inc), eletriptan HBr (Relpax, made by Pfizer, Inc), and zolmitriptan (Zomig and Zomig ZMT, made by AstraZeneca Pharmaceuticals LP).

Paroxetine (Paxil, Paxil CR) Linked to Increased Risk for Suicidality in Young Adults

The FDA has approved safety labeling changes to warn of the potential increased risk for suicidal behavior in paroxetine-treated patients. Careful monitoring is warranted for all patients regardless of the disorder being treated and may be of particular importance for young adults and those with improving depression.

The warning was based on data from a recent meta-analysis of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adults with psychiatric disorders, such as major depressive disorder (MDD), as well as other depression and nondepression disorders. The trials included 8958 paroxetine-treated patients and 5953 patients who received placebo.

Study results showed that paroxetine therapy was linked to an increased frequency of suicidal behavior in young adults aged 18 to 24 years (2.19% vs placebo, 0.92%). Although not statistically significant, the increase occurred in patients with depressive and nondepressive conditions alike. The FDA notes that no such increase was observed among adults aged 25 years and older.

Paroxetine therapy was also linked to a significantly increased frequency of suicidal behavior among adults of all ages with MDD (0.32% vs placebo, 0.05%). Despite the statistical significance of the finding, the FDA advises that it be interpreted with caution because of the small absolute number and incidence of events.

Although all cases of suicidal behavior in adult patients with MDD involved nonfatal suicide attempts, the majority of these events (8/11) occurred in younger adults aged 18 to 30 years, suggesting that the risk for suicidality across psychiatric disorders in younger adults may extend beyond the age of 24 years.

The FDA notes that the potential increased risk for suicidal behavior in MDD patients was observed despite substantial evidence for efficacy in those receiving paroxetine, as determined using standardized disease-specific instruments, such as the Hamilton Depression and Montgomery-Asberg Depression rating scales. Most patients had an identified social stressor at the time of the event.

http://www.fda.gov/medwatch/safety/2..._quickview.htm

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

* Identify the risks associated with continuation and discontinuation of paroxetine therapy during pregnancy.
* Explain the risks associated with concomitant use of paroxetine and triptans.
* Describe the potential for suicidal behavior in young adults and those with improving depression.

Pearls for Practice

* Study results suggest that continued use of selective serotonin reuptake inhibitors, including paroxetine HCl, past the 20th week of pregnancy is linked to a 6-fold increase in the risk for persistent pulmonary hypertension in newborns. Those who discontinue antidepressant therapy are 5 times more likely to have a relapse during pregnancy compared with those who continue treatment.
* Concomitant use of selective serotonin reuptake inhibitors, such as paroxetine, with 5-hydroxytryptamine-receptor agonists (triptans) yields an additive effect on serotonin levels that can lead to potentially life-threatening serotonin syndrome. Careful monitoring is therefore advised for paroxetine-treated patients in whom concomitant triptan therapy is clinically warranted, particularly during initiation of therapy, dose increases, or the addition of another serotonergic drug.
* In clinical studies, use of paroxetine for depression and other disorders was linked to an increased frequency of suicidal behavior in young adults aged 18 to 24 years (2.19% vs placebo, 0.92%). No such increase was observed among adults aged 25 years and older. All cases of suicidal behavior in patients treated for major depressive disorder involved nonfatal suicide attempts, with the majority occurring in younger adults aged 18 to 30 years. The increased risk for suicidal behavior occurred despite the apparent efficacy of paroxetine therapy in alleviating depressive symptoms. Most had an identified social stressor at the time of the event.

[LinLou]

Do doctors actually receive this stuff to read? Because my doctor told me last February that "suicidal risks don't happen with adults...just children". She said this after I told her that every time I try a new AD, I get thoughts of wanting to die. So basically she didn't believe a word I said. She said I felt that way because I read the warning label that was meant for children, and I wouldn't feel that way if I would stop reading warning labels.

I didn't want to tell her I was also having homicidal thoughts TOWARDS HER for saying that.

[Delynbetter]

CME, just as prescribing pamphlets, are scattered all over the place for doctors. There is no way they can actually notice everything that comes - or like my husband, they don't go to Medscape looking for CME. I even have a doc (won't mention any names or relation) who wants ME to take some online CME for him because 'he doesn't have time'. Yes, that warranted a 'bite me'.

Alto, thanks. I'll be printing this out for the hubby to get some credit on.

[scotty]

Originally Posted by IWGMLB

Do doctors actually receive this stuff to read? Because my doctor told me last February that "suicidal risks don't happen with adults...just children". She said this after I told her that every time I try a new AD, I get thoughts of wanting to die. So basically she didn't believe a word I said. She said I felt that way because I read the warning label that was meant for children, and I wouldn't feel that way if I would stop reading warning labels.

I didn't want to tell her I was also having homicidal thoughts TOWARDS HER for saying that.

IW.. can I use the above statement as part of my testimony at the FDA? No names, just the circumstance.

[Hughie]

Originally Posted by scotty

These are in a new permanent home at the top of this page!!! No need to bump, but thanks for the thought!!

HI Scotty Im new on here can you read the message I put on todat and give me some advice please ive een on Paxil for 8 years.