FDA warning SUICIDE on 11 Epilepsy drugs inc Neurontin

FDA warning SUICIDE on 11 Epilepsy drugs inc Neurontin

Joined: April 1st, 2004, 4:56 pm

January 31st, 2008, 8:27 pm #1

U.S. warns of suicidal actions with epilepsy drugs
 

http://uk.reuters.com/article/healthNews/idUKN3134112620080131



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WASHINGTON (Reuters) - U.S. health officials alerted doctors on Thursday that medicines used to treat epilepsy and psychiatric disorders may raise the risk of suicidal thoughts and behavior.<SPAN id=midArticle_byline></SPAN>
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The Food and Drug Administration said it analyzed studies of 11 epilepsy drugs including Pfizer Inc's Neurontin, Abbott Laboratories Inc's Depakote and Johnson & Johnson's Topamax. The studies included nearly 44,000 patients.
<SPAN id=midArticle_1></SPAN>
The analysis found patients treated with the drugs faced about twice the risk of suicidal thoughts or behavior compared to others who got a placebo.
<SPAN id=midArticle_2></SPAN>
The FDA estimated there were two more cases per every 1,000 patients given the drugs instead of a placebo.
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About 0.4 percent of patients given the drugs reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients, the FDA said.
<SPAN id=midArticle_4></SPAN>
Four people who were taking one of the epilepsy drugs committed suicide, while none of the placebo patients did.
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The agency said it expected the risk was shared by all anti-epileptic drugs and that changes to the drugs' prescribing instructions would be applied broadly throughout the class.
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Officials at Pfizer, J&J and Abbott could not immediately be reached for comment.
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(Reporting by Lisa Richwine, editing by Jeffrey Benkoe and Dave Zimmerman);
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January 31st, 2008, 8:31 pm #2

<FONT size=2><EM>Psychiatric News</EM> May 20, 2005
Volume 40 Number 10
© 2005 </FONT><FONT color=#004586 size=2>American Psychiatric Association</FONT>
<FONT size=2>p. 12
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http://pn.psychiatryonline.org/cgi/cont ... l/40/10/12
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FDA Wants Reanalysis of Data On Seizure Drug's Suicide Risk <STRONG>Jim Rosack </STRONG>
<B>Nearly 300 reports of suicides by patients taking the anticonvulsant Neurontin have convinced the FDA to look closer at adverse-event reports from clinical trials.
</B>U.S. regulators have asked pharmaceutical companies to reexamine clinical trials data on anticonvulsant medications to determine whether the medications potentially increase suicidal thoughts and actions.
The Food and Drug Administration (FDA) requested last month that the companies undertake an analysis similar to what the agency received from makers of antidepressant medications last year. That analysis led to an independent review of the data by Columbia University suicide experts and eventually resulted in newly ordered black-box warnings.
The FDA request is in part related to a citizens' petition filed in May 2004 by a New York attorney, Andrew Finkelstein. Finkelstein, who has handled scores of personal injury cases involving medications, has been investigating claims from patients who said they attempted suicide while taking Neurontin (gabapentin), as well as from family members of patients who committed suicide while taking the medication.
In his 2004 petition, Finkelstein asked the FDA to require Neurontin maker Pfizer to add a black-box warning to the drug's label.
In March Finkelstein submitted 258 MedWatch adverse-event reports and the death certificates of people who had been taking gabapentin at the time they committed suicide.
In an accompanying letter addressed to Russell Katz, M.D., director of the FDA Division of Neuropharmacological Drug Products, Finkelstein noted that a suspected connection between gabapentin and suicide was "both known and a major concern" of the FDA at the time it approved the drug.
In December 1992 the FDA reviewer who handled the new drug application for Neurontin, Cynthia McCormick, Ph.D., noted that "serious adverse events may limit the drug's usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or lead to suicide, as it has resulted in some suicidal attempts during clinical trials."
The FDA approved Neurontin for "adjunctive therapy in the treatment of partial seizures" in patients aged 3 and older and for the management of postherpetic neuralgia in adults. However, Finkelstein added, the safety concern is amplified by the fact that the drug, originally developed and marketed by Parke-Davis prior to its merger with Pfizer, is extensively prescribed off label. Neurontin off-label prescribing increased from $23 million in 1993 to $2.7 billion in 2004, becoming one of Pfizer's best-selling products.
Yet, Finkelstein said, "The FDA has taken no affirmative action to require Parke-Davis to advise physicians or their patients of the risks of suicide associated with Neurontin."
Finkelstein further charged, "The FDA's complete inaction in protecting the health and safety of United States' citizens from a known serious risk of an approved drug is highly suspicious given the recent exposed relationships between pharmaceutical companies and the FDA."
The FDA's Katz, in a letter dated April 12, acknowledged that the agency is "taking this matter very seriously" and was initiating its request to drug companies that make anticonvulsants to address the question.
"These analyses are complex," Katz wrote, "and will require a detailed re-examination of all adverse events that could possibly be related to the events of interest and a blinded recategorization of these events into relevant categories. We believe that these analyses are crucial to deciding the obviously important question of whether or not these drugs do increase the risk of suicidality."
Katz's letter did not address whether the group of suicidology experts at Columbia University who played a significant role in the antidepressant analysis would be involved in the anticonvulsant review. Requests by Psychiatric News to the FDA for clarification had not been answered by press time.
Finkelstein welcomed the FDA's decision to review the clinical trials data, however, and continued to call on the agency to inform the public of the issue.
"The FDA is duty bound," he wrote in an April 15 reply to Katz, "to advise both prescribing physicians and the public of the actions you have undertaken."
Finkelstein noted that when the SSRI review was undertaken, a public health advisory was issued "alerting prescribing physicians and consumers to be on the lookout for increased depression and suicidality when commencing SSRI treatment."
Finkelstein urged the FDA to issue a similar public health advisory regarding gabapentin and suicidality, "discouraging the use of Neurontin for any condition other than the approved use," and alerting physicians, patients, and family members to monitor those taking the drug.
The approved label for gabapentin includes a warning about neuropsychiatric events, including "emotional lability" and "hostility, including aggressive behaviors." In addition, the label lists "suicide gesture" as a "rare" nervous system adverse event observed in clinical trials. <IMG alt={blacksquare} src="http://pn.psychiatryonline.org/math/squf.gif" border=0>
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Joined: April 1st, 2004, 4:56 pm

January 31st, 2008, 8:37 pm #3

<P class=pagetitle><A name=top></A>Suicidality and Antiepileptic Drugs

<P class=pagetitle>&nbsp;

<P class=pagetitle>http://www.fda.gov/CDER/drug/infopage/a ... efault.htm

<IMG height=1 src="http://www.fda.gov/cder/templates/graphics/horz_bar.gif" width="100%" vspace=5> <STRONG>FDA ALERT [1/31/2008] - </STRONG><FONT size=2><STRONG>The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions.&nbsp;These drugs are commonly referred to as antiepileptic drugs (see the list below).&nbsp;In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%).&nbsp;The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs.&nbsp;Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed.&nbsp;The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.&nbsp; </STRONG></FONT>

<FONT size=2><STRONG>All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.&nbsp;</STRONG></FONT>

<P align=center><FONT size=2>This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA intends to update this document when additional information or analyses become available. </FONT><IMG height=1 src="http://www.fda.gov/cder/templates/graphics/horz_bar.gif" width="100%" vspace=3>
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January 31st, 2008, 8:39 pm #4

The following is a list of antiepileptic drugs* included in the analyses:

Labeling and approval history from Drugs@FDA.
* Some of these drugs are also available in generic form.

&nbsp;

http://www.fda.gov/CDER/drug/infopage/a ... efault.htm
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January 31st, 2008, 8:49 pm #5

U.S. warns of suicidal actions with epilepsy drugs
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http://uk.reuters.com/article/healthNews/idUKN3134112620080131



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WASHINGTON (Reuters) - U.S. health officials alerted doctors on Thursday that medicines used to treat epilepsy and psychiatric disorders may raise the risk of suicidal thoughts and behavior.<SPAN id=midArticle_byline></SPAN>
<SPAN id=midArticle_0></SPAN>
The Food and Drug Administration said it analyzed studies of 11 epilepsy drugs including Pfizer Inc's Neurontin, Abbott Laboratories Inc's Depakote and Johnson & Johnson's Topamax. The studies included nearly 44,000 patients.
<SPAN id=midArticle_1></SPAN>
The analysis found patients treated with the drugs faced about twice the risk of suicidal thoughts or behavior compared to others who got a placebo.
<SPAN id=midArticle_2></SPAN>
The FDA estimated there were two more cases per every 1,000 patients given the drugs instead of a placebo.
<SPAN id=midArticle_3></SPAN>
About 0.4 percent of patients given the drugs reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients, the FDA said.
<SPAN id=midArticle_4></SPAN>
Four people who were taking one of the epilepsy drugs committed suicide, while none of the placebo patients did.
<SPAN id=midArticle_5></SPAN>
The agency said it expected the risk was shared by all anti-epileptic drugs and that changes to the drugs' prescribing instructions would be applied broadly throughout the class.
<SPAN id=midArticle_6></SPAN>
Officials at Pfizer, J&J and Abbott could not immediately be reached for comment.
<SPAN id=midArticle_7></SPAN>
(Reporting by Lisa Richwine, editing by Jeffrey Benkoe and Dave Zimmerman);
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<P id=breadcrumbs>Home <SPAN class=arrow>&nbsp;</SPAN> Safety information <SPAN class=arrow>&nbsp;</SPAN> Safety warnings, alerts and recalls
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<ul>
			<li>drug alerts on defective medicines; </li>
			<li>medical device alerts and their predecessors; and</li>
			<li>safety warnings and messages about medicines, including letters sent to health professionals.<br/></li></ul>\
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  • drug alerts on defective medicines;&nbsp;
  • medical device alerts and their predecessors; and
  • safety warnings and messages about medicines, including letters sent to health professionals.
    </LI>
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<H2 class=clearing>Latest Safety warnings, alerts and recalls</H2>
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[*]
<SPAN>30 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2008/004 - Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference: 84006182</FONT>
The manufacturer has expanded this recall to include all lots made prior to the tool modification in 2006.
<!-- show the item in the list --></LI>
[*]
<SPAN>29 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>Class 2 Drug Alert (action within 48 hours): Novartis Pharmaceuticals UK Ltd - Viscotears Single Dose Unit 2.0mg/g Eye Gel - EL(08)A/2</FONT>
Novartis Pharmaceutical UK Ltd are voluntarily recalling five batches of Viscotears Single Dose Unit 2.0mg/g Eye Gel as a precautionary measure due to potential lack of sterility assurance.
<!-- show the item in the list --></LI>
[*]
<SPAN>22 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>Class 3 Drug Alert (action within 5 days): Metwest Pharmaceuticals Ltd - Simvastatin Tablets 10mg - EL(08)A/1</FONT>
Metwest Pharmaceuticals Ltd are recalling a batch of Simvastatin Tablets 10mg because the blister foil is incorrectly labelled as Simvastatin 20mg. All other labelling is correct and tablets present in the blisters are 10mg strength.
<!-- show the item in the list --></LI>
[*]
<SPAN>16 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2008/003 - Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers)</FONT>
The manufacturer has extended the recall of these implants which may have incorrect alloy composition.
<!-- show the item in the list --></LI>
[*]
<SPAN>15 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2008/002 - Birthing beds. Huntleigh Healthcare Birthright and Hoskins Birthcare</FONT>
We have been informed that these beds can become unstable and tip if patients, visitors or staff sit or kneel near the foot end of the bed.
<!-- show the item in the list --></LI>
[*]
<SPAN>03 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>Safety information for healthcare professionals sent in December 2007</FONT>
A list of letters sent to healthcare professionals in December 2007, to inform of new safety information and advice.
<!-- show the item in the list --></LI>
[*]
<SPAN>02 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2008/001 - All medical devices</FONT>
It is evident that there is significant under-reporting of medical device related adverse incidents. It is important that comprehensive, effective and regularly reviewed and maintained systems for reporting medical device related adverse incidents to the MHRA are set in place in every health and social care organisation.
<!-- show the item in the list --></LI>
[*]
<SPAN>02 Jan 2008</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>Monthly list of MDAs - 2007</FONT>
A month-by-month list of Medical Device Alerts that we have issued during 2007.
<!-- show the item in the list --></LI>
[*]
<SPAN>20 Dec 2007</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2007/100 - Volumetric infusion pump. Smiths Medical (Graseby) 500 and 505 volumetric infusion pumps - all models</FONT>
We have been informed that there is the possibility of delivering an unintended 1.7 ml bolus if the pump door is opened and then immediately closed following a stoppage of the pump.
<!-- show the item in the list --></LI>
[*]
<SPAN>17 Dec 2007</SPAN><SPAN class=divider>|</SPAN> <FONT color=#0a3296>MDA/2007/099 - Blood/solution warming units. All Smiths Medical Level 1® H-1200 fast flow fluid warmers with an integrated H-31B air detector/clamp and H-1025 fast flow fluid warmers with the optional H-31B air detector/clamp</FONT>
There is a risk of air embolism if the power to the fluid warmer unit is interrupted during an air detection event. We advise users to discontinue use of these devices until further notice.
</LI>[/list]

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Joined: April 1st, 2004, 4:56 pm

January 31st, 2008, 8:51 pm #6

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Joined: September 5th, 2005, 7:11 pm

January 31st, 2008, 11:33 pm #7

http://www.drugs-forum.co.uk/forum/arch ... 27981.html

An MHRA spokesman said that, as the accompanying information leaflet for both prescribers and users of Stilnoct already warns of possible side-effects including nightmares, night restlessness, sleepwalking, hallucinations and other problems, it was not necessary to conduct any inquiry into the drug or the advice that goes with it.



other problems must be the catagory that include the deaths which truly are a problem and unlikely to be on the leaflet

adverse drug reactions tracking early 2006 for zolpidem - stilnoct - ambien and the fatal outcomes

http://www.mhra.gov.uk/home/groups/publ ... 587079.pdf
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