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Re: Luvox, others, FDA has been there before » Phillipa

Posted by yxibow on April 10, 2009, at 2:45:56

In reply to Now It's luvox and Others., posted by Phillipa on April 9, 2009, at 20:25:22

> More warnings now it's luvox and other meds triptans etc. Phillipa
>
> April 8, 2009 The US Food and Drug Administration (FDA) has approved safety labeling revisions to provide updated information regarding drug interactions that raise the risk for serotonin syndrome in patients receiving treatment with fluvoxamine maleate, drug interactions between angiotensin-converting enzyme inhibitors and injectable gold therapy, and the risk for hepatotoxicity in patients receiving nitrofurantoin therapy.
>
> Additional Agents Implicated in SSRI-Related Risk for Serotonin Syndrome
>
> On February 24, the FDA approved class labeling changes for fluvoxamine maleate tablets and extended-release capsules (Luvox and Luvox CR, Jazz Pharmaceuticals) to provide updated information regarding drug interactions that increase the risk for serotonin-related adverse events in patients receiving treatment with selective serotonin reuptake inhibitors (SSRIs) such as fluvoxamine. This information also applies to selective serotonin-norepinephrine reuptake inhibitors.
>
> The agency previously warned of the risk for potentially life-threatening serotonin syndrome in patients receiving 5-hydroxytryptamine receptor agonists (triptans) in conjunction with SSRIs.
>
> An expanded section of the monograph now warns that serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions can occur with use of SSRIs alone but are more likely with concomitant use of serotonergic drugs (including triptans), agents that impair serotonin metabolism (including monoamine oxidase inhibitors [MAOIs]), or antipsychotics and other dopamine antagonists.
>
> Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, and coma); autonomic instability (eg, tachycardia, labile blood pressure, and hyperthermia); neuromuscular aberrations (eg, hyperreflexia and incoordination); and/or gastrointestinal symptoms (eg, nausea, vomiting, and diarrhea). Severe cases can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
>
> Clinicians are reminded that concomitant treatment of depression with MAOIs and SSRIs is contraindicated. SSRI-treated patients receiving triptans should be followed up closely, particularly during initiation of therapy, dose increases, or the addition of another serotonergic drug.
>
> Concomitant use of SSRIs with serotonin precursors (eg, tryptophan) is not recommended. Treatment with SSRIs and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately in patients who develop symptoms of serotonin syndrome.
>
> Fluvoxamine tablets and controlled-release capsules are indicated for the treatment of obsessive-compulsive disorder; the capsules can also be used to treat social anxiety disorder.
>


This is more aas protection between the new patented re-release of Luvox and the FDA.

There was a warning recently about EVERY antidepressant made since the 1960s that suicide could happen and all sorts of things which may be true but were released in light of a lot of litigation and other factors.

The same went for EVERY sleep agent still marketed since about the same time also that people could sleepwalk and all sorts of things that are theoretically possible but do NOT happen regularly to people.


And also because of some cases of liver damage ALL COX-2 inhibitors were withdrawn except for Celebrex. Litigation also ensued. Yes, we need to be cautious with drugs, but personally at least my physician thought that was a complete travesty. Of course people are free to disagree.


Yes, serotonin syndrome can occur with any SSRI and other agents, and its something actually that wouldn't be clear to the patient at the time, so it is something to be concerned about, but careful monitoring and proper prescribing rarely brings on SS.

NMS is very rare with APs, especially modern ones, and I would imagine the same with SSRIs. Probably as rare as torsades de pointes.

Of course other drugs being taken, such as sumatriptan for migraine, should be discussed with your psychiatrist -- all agents, including OTC supplements should be mentioned.

As far as myself, I do take 5-HTP and l-tryptophan with a modest dose of Anafranil plus Seroquel and other agents not directly related to serotonin.

But, anyone should mention such supplements to their doctor. I'm not suggesting that anyone should add what I take as supplements -- but l-tryptophan is at least known somewhat in the psychiatric community as a possible agent to help sleep.

We have enough fear and sorrow in our lives -- I think sometimes this goes overboard to the point that NO medication will ever reach anyone because of some possible rarity.

And I'm speaking of someone who has iatrogenic neurological things probably never seen before by psychiatry. But I am one of those rare exceptions with neuroleptics.

So do we wistfully talk about new pipelines and approvals for medications to palliate our ills, or do we argue and call for their removal from the market 6 months after they come out ?

I guess its a touchy balance between the sky is falling, side effects that come with all medications, and real disasters.

Yes, the first SSRI, not released here, but in Europe caused travesties. Thalidomide caused countless problems yet it is allowed now in special situations.

Lariam, related to quinine, for malaria prevention can and has caused psychiatric disorders and other problems. Doxycycline is recommended now, at least by the army.

tidings

-- Jay

 

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