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	<title>Comments on: Journal Ads &#038; Accurate Claims: Spielmans Explains</title>
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	<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 25 Jul 2008 14:30:23 +0000</pubDate>
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		<title>By: truthman30</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-302050</link>
		<dc:creator>truthman30</dc:creator>
		<pubDate>Mon, 21 Apr 2008 01:16:48 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-302050</guid>
		<description>HC..

I was not aware  you were on Zoloft..
On a different note..
I worked with a girl who was prescribed Zyprexa..
She was extremely vulnerable and I witnessed first hand what  effects this disgusting psychiatric drug can have on an individual..
Her tongue would dart round her mouth like a lizard, she was visibly shaking every day and her puplis were huge, she ended up in the psych ward twice not long after being prescribed this poison, her weight also ballooned within a few months..

HC..

In light of realizing that you are on medication yourself, I can kind of understand why you vehemently try to defend these meds all the time..
Maybe when you hit withdrawal or have a bad reaction you will see the truth of the devastation these meds cab cause..
Until then, I wish you luck with your journey..</description>
		<content:encoded><![CDATA[<p>HC..</p>
<p>I was not aware  you were on Zoloft..<br />
On a different note..<br />
I worked with a girl who was prescribed Zyprexa..<br />
She was extremely vulnerable and I witnessed first hand what  effects this disgusting psychiatric drug can have on an individual..<br />
Her tongue would dart round her mouth like a lizard, she was visibly shaking every day and her puplis were huge, she ended up in the psych ward twice not long after being prescribed this poison, her weight also ballooned within a few months..</p>
<p>HC..</p>
<p>In light of realizing that you are on medication yourself, I can kind of understand why you vehemently try to defend these meds all the time..<br />
Maybe when you hit withdrawal or have a bad reaction you will see the truth of the devastation these meds cab cause..<br />
Until then, I wish you luck with your journey..</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-301865</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Sun, 20 Apr 2008 22:23:06 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-301865</guid>
		<description>HC: "If I take a drug in a trial and I get murdered in a bank robbery, that gets reported as a side effect. And the connection is…????"  

There isn't any connection whatsoever, which is no doubt why getting murdered in a bank robbery and any other disabling or terminal non-drug related scenarios are not listed as side effects of a drug.  If a child suffers injury from a prescription drug, the fact that other drugs also carry the same side effect makes some kind of difference to that child's injury because...???</description>
		<content:encoded><![CDATA[<p>HC: &#8220;If I take a drug in a trial and I get murdered in a bank robbery, that gets reported as a side effect. And the connection is…????&#8221;  </p>
<p>There isn&#8217;t any connection whatsoever, which is no doubt why getting murdered in a bank robbery and any other disabling or terminal non-drug related scenarios are not listed as side effects of a drug.  If a child suffers injury from a prescription drug, the fact that other drugs also carry the same side effect makes some kind of difference to that child&#8217;s injury because&#8230;???</p>
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		<title>By: AA</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-301805</link>
		<dc:creator>AA</dc:creator>
		<pubDate>Sun, 20 Apr 2008 21:28:05 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-301805</guid>
		<description>HC,

In previous threads, you seemed to not understand why people got so mad at you.   Well, calling someone an idiot will not cause people to be polite.  I don't see anything that PG said that deserved that type of response.

Saying that all drugs have side effects is a cop out argument.   You can't compare for example the side effects of Allegra to an antipsychotic.   Even Lipitor, which seems like it has horrific side effects doesn't seem to compare to an antipsychotic.  Of course, someone on Lipitor will shoot down my argument.

Antipsychotics are way over prescribed for kids big time.   So yes, if you are prescribing an antipsychotic that someone doesn't need, you are essentially murdering them due to the horrific side effects.   I know that is blunt but let's call it what it is.

Finally, if you don't believe that SSRIs can cause homicidal thinking, google Jay Cohen, a psychiatrist who has prescribed these meds but has information on his website that they definitely can cause homicidal thinking.    I can tell you from personal experience that if I had stayed on Celexa, there is no doubt in my mind, I would eventually become either homicidal or suicidal.     I became suicidal on Prozac.  But you refuse to believe personal accounts so I am wasting my time.

I just hope for your sake that the Zoloft you are on continues to work for you.  For a year and a half, it was a great drug for me.   Then I became severely agitated.

No, I don't have BP in case anyone reading this post was wondering.

AA</description>
		<content:encoded><![CDATA[<p>HC,</p>
<p>In previous threads, you seemed to not understand why people got so mad at you.   Well, calling someone an idiot will not cause people to be polite.  I don&#8217;t see anything that PG said that deserved that type of response.</p>
<p>Saying that all drugs have side effects is a cop out argument.   You can&#8217;t compare for example the side effects of Allegra to an antipsychotic.   Even Lipitor, which seems like it has horrific side effects doesn&#8217;t seem to compare to an antipsychotic.  Of course, someone on Lipitor will shoot down my argument.</p>
<p>Antipsychotics are way over prescribed for kids big time.   So yes, if you are prescribing an antipsychotic that someone doesn&#8217;t need, you are essentially murdering them due to the horrific side effects.   I know that is blunt but let&#8217;s call it what it is.</p>
<p>Finally, if you don&#8217;t believe that SSRIs can cause homicidal thinking, google Jay Cohen, a psychiatrist who has prescribed these meds but has information on his website that they definitely can cause homicidal thinking.    I can tell you from personal experience that if I had stayed on Celexa, there is no doubt in my mind, I would eventually become either homicidal or suicidal.     I became suicidal on Prozac.  But you refuse to believe personal accounts so I am wasting my time.</p>
<p>I just hope for your sake that the Zoloft you are on continues to work for you.  For a year and a half, it was a great drug for me.   Then I became severely agitated.</p>
<p>No, I don&#8217;t have BP in case anyone reading this post was wondering.</p>
<p>AA</p>
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		<title>By: HorusCat</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294660</link>
		<dc:creator>HorusCat</dc:creator>
		<pubDate>Sat, 19 Apr 2008 02:38:35 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294660</guid>
		<description>Glen,
I am not sure we disagree, so much as I swim in these waters, so I read the ads differently than you do.  I read that bit from Risperdal, and think, "well, yeah, try to differentiate yourself from Zyprexa, but we all know people gain weight on Risperdal, too, just not as much."  So maybe I am saying to myself what you are saying in your article.  

As far as stuff like the missing ziprasidone data, I think another sort of short-hand is occurring.  Doctors think in terms of class effects, and don't always draw a bright line between manic and mixed episodes.  In all the time I sold an atypical, I never had a doc ask me a distinguishing question about effects in manic vs mixed episodes.  Most often, they concede efficacy in the depressed bipolar patient but question efficacy in true mania.

Anyway, I'm sort of rambling around.  I think you think doctors 1) read the advertising and 2) use it as a source of information.  Knowing my own approach to advertising in the periodicals of my choice...(and to commercials, and pop-ups, etc)  It would be interesting to see the internal data pharma marketers have on ROI with journal ads.  They are already finding that DTC may not be the best way to drive market share for an established brand.  I wonder what would happen if all of pharma just quit advertising in journals?  Would anyone notice?</description>
		<content:encoded><![CDATA[<p>Glen,<br />
I am not sure we disagree, so much as I swim in these waters, so I read the ads differently than you do.  I read that bit from Risperdal, and think, &#8220;well, yeah, try to differentiate yourself from Zyprexa, but we all know people gain weight on Risperdal, too, just not as much.&#8221;  So maybe I am saying to myself what you are saying in your article.  </p>
<p>As far as stuff like the missing ziprasidone data, I think another sort of short-hand is occurring.  Doctors think in terms of class effects, and don&#8217;t always draw a bright line between manic and mixed episodes.  In all the time I sold an atypical, I never had a doc ask me a distinguishing question about effects in manic vs mixed episodes.  Most often, they concede efficacy in the depressed bipolar patient but question efficacy in true mania.</p>
<p>Anyway, I&#8217;m sort of rambling around.  I think you think doctors 1) read the advertising and 2) use it as a source of information.  Knowing my own approach to advertising in the periodicals of my choice&#8230;(and to commercials, and pop-ups, etc)  It would be interesting to see the internal data pharma marketers have on ROI with journal ads.  They are already finding that DTC may not be the best way to drive market share for an established brand.  I wonder what would happen if all of pharma just quit advertising in journals?  Would anyone notice?</p>
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		<title>By: Glen Spielmans</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294649</link>
		<dc:creator>Glen Spielmans</dc:creator>
		<pubDate>Sat, 19 Apr 2008 02:25:48 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294649</guid>
		<description>HorusCat,

But the 1.6 kg weight gain was over a 3-wk period.  Even Zyprexa wouldn't increase weight by 40 lbs over such a short time frame.  In any case, I appreciate your point of view, though obviously we disagree somewhat.</description>
		<content:encoded><![CDATA[<p>HorusCat,</p>
<p>But the 1.6 kg weight gain was over a 3-wk period.  Even Zyprexa wouldn&#8217;t increase weight by 40 lbs over such a short time frame.  In any case, I appreciate your point of view, though obviously we disagree somewhat.</p>
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		<title>By: HorusCat</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294581</link>
		<dc:creator>HorusCat</dc:creator>
		<pubDate>Sat, 19 Apr 2008 01:16:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294581</guid>
		<description>Glen,
Your reply is appreciated.  Again, I would suggest that the marketers are using short-hand to communicate to physicians who understand the use of these drugs in a certain context--that a drug is going to be used, not placebo, and that (unless the drug is a typical), there will be weight gain with it.  An outsider may think, 3.5 lbs, that's significant...but a psychiatrist would say, well, compared to 40 lbs with Zyprexa...  In some respects, it would be like an alien trying to understand our car commercials...what does a sexy woman have to do with a vehicle to transport you from point A to point B?  But WE understand perfectly (well, my husband seems to!).  

And I would say that 3.5 lbs isn't significant in a 150 lb man, especially when the medically accepted definition of significant (which every psychiatrist now knows!) is gaining 7% or more of body weight.</description>
		<content:encoded><![CDATA[<p>Glen,<br />
Your reply is appreciated.  Again, I would suggest that the marketers are using short-hand to communicate to physicians who understand the use of these drugs in a certain context&#8211;that a drug is going to be used, not placebo, and that (unless the drug is a typical), there will be weight gain with it.  An outsider may think, 3.5 lbs, that&#8217;s significant&#8230;but a psychiatrist would say, well, compared to 40 lbs with Zyprexa&#8230;  In some respects, it would be like an alien trying to understand our car commercials&#8230;what does a sexy woman have to do with a vehicle to transport you from point A to point B?  But WE understand perfectly (well, my husband seems to!).  </p>
<p>And I would say that 3.5 lbs isn&#8217;t significant in a 150 lb man, especially when the medically accepted definition of significant (which every psychiatrist now knows!) is gaining 7% or more of body weight.</p>
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		<title>By: HorusCat</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294578</link>
		<dc:creator>HorusCat</dc:creator>
		<pubDate>Sat, 19 Apr 2008 01:12:02 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-294578</guid>
		<description>pg,
You're an idiot.  Nowhere did I suggest using ziprasidone in children.  No article appears suggesting efficacy for ziprasidone in children with bipolar disorder.  You lose all credibility when you automatically shove every discussion into your "we are murdering our children!" cubbyhole. 

Read the side effects on any medication.  They are all the same, in varying proportions.  If I take a drug in a trial and I get murdered in a bank robbery, that gets reported as a side effect.  And the connection is...????</description>
		<content:encoded><![CDATA[<p>pg,<br />
You&#8217;re an idiot.  Nowhere did I suggest using ziprasidone in children.  No article appears suggesting efficacy for ziprasidone in children with bipolar disorder.  You lose all credibility when you automatically shove every discussion into your &#8220;we are murdering our children!&#8221; cubbyhole. </p>
<p>Read the side effects on any medication.  They are all the same, in varying proportions.  If I take a drug in a trial and I get murdered in a bank robbery, that gets reported as a side effect.  And the connection is&#8230;????</p>
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		<title>By: Glen Spielmans</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-292969</link>
		<dc:creator>Glen Spielmans</dc:creator>
		<pubDate>Fri, 18 Apr 2008 17:10:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-292969</guid>
		<description>HorusCat,

Thank you for your comments.  

There may be supporting data for ziprasidone in mixed episodes.  However, such data were not provided in the source cited by the advertisement.  We did not search through every clinical trial ever done, just the sources cited by the ads.  I think it is reasonable to expect that a source cited in an ad should provide clear support for the advertising claim.

It is an open question what exactly “low weight gain” might have been referencing.  However, given that the weight gain was 1.6 kg on risperidone vs. a .25 kg decrease on placebo over a 3-week period, a difference that was statistically significant, we did not believe that the claim was supported.  If they were referencing that few people gained 7% of body weight in 3 weeks, then I believe they should have made such a claim specifically.  

Thank you again for your interest in the study.</description>
		<content:encoded><![CDATA[<p>HorusCat,</p>
<p>Thank you for your comments.  </p>
<p>There may be supporting data for ziprasidone in mixed episodes.  However, such data were not provided in the source cited by the advertisement.  We did not search through every clinical trial ever done, just the sources cited by the ads.  I think it is reasonable to expect that a source cited in an ad should provide clear support for the advertising claim.</p>
<p>It is an open question what exactly “low weight gain” might have been referencing.  However, given that the weight gain was 1.6 kg on risperidone vs. a .25 kg decrease on placebo over a 3-week period, a difference that was statistically significant, we did not believe that the claim was supported.  If they were referencing that few people gained 7% of body weight in 3 weeks, then I believe they should have made such a claim specifically.  </p>
<p>Thank you again for your interest in the study.</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-291148</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Fri, 18 Apr 2008 01:01:56 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-291148</guid>
		<description>Is the above the 'supporting data' ?</description>
		<content:encoded><![CDATA[<p>Is the above the &#8217;supporting data&#8217; ?</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-291147</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Fri, 18 Apr 2008 01:00:37 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/04/journal-ads-accurate-claims-spielmans-explains/#comment-291147</guid>
		<description>THIS is good for CHILDREN?

http://www.rxlist.com/cgi/generic/ziprasidone_ad.htm

Following is a list of COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses &#62; 4 mg/day within the database of 3834 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those event terms that were so general as to be uninformative, events reported only once and that did not have a substantial probability of being acutely life-threatening, events that are part of the illness being treated or are otherwise common as background events, and events considered unlikely to be drug-related. It is important to emphasize that, although the events reported occurred during treatment with ziprasidone, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole: Frequent: abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident.

Cardiovascular System: Frequent: tachycardia, hypertension, postural hypotension; Infrequent: bradycardia, angina pectoris, atrial fibrillation; Rare: first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis.

Digestive System: Frequent: anorexia, vomiting; Infrequent: rectal hemorrhage, dysphagia, tongue edema; Rare: gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena.

Endocrine: Rare: hypothyroidism, hyperthyroidism, thyroiditis.

Hemic and Lymphatic System: Infrequent: anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy; Rare: thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia.

Metabolic and Nutritional Disorders: Infrequent: thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia; Rare: BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemic reaction, hypomagnesemia, ketosis, respiratory alkalosis.

Musculoskeletal System: Frequent: myalgia; Infrequent: tenosynovitis; Rare: myopathy.

Nervous System: Frequent: agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy; Infrequent: paralysis; Rare: myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus.

Respiratory System: Frequent: dyspnea; Infrequent: pneumonia, epistaxis; Rare: hemoptysis, laryngismus.

Skin and Appendages: Infrequent: maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash.

Special Senses: Frequent: fungal dermatitis; Infrequent: conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia; Rare: eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis.

Urogenital System: Infrequent: impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention, metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria; Rare: gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage.</description>
		<content:encoded><![CDATA[<p>THIS is good for CHILDREN?</p>
<p><a href="http://www.rxlist.com/cgi/generic/ziprasidone_ad.htm" rel="nofollow">http://www.rxlist.com/cgi/generic/ziprasidone_ad.htm</a></p>
<p>Following is a list of COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses &gt; 4 mg/day within the database of 3834 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those event terms that were so general as to be uninformative, events reported only once and that did not have a substantial probability of being acutely life-threatening, events that are part of the illness being treated or are otherwise common as background events, and events considered unlikely to be drug-related. It is important to emphasize that, although the events reported occurred during treatment with ziprasidone, they were not necessarily caused by it.</p>
<p>Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.</p>
<p>Body as a Whole: Frequent: abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident.</p>
<p>Cardiovascular System: Frequent: tachycardia, hypertension, postural hypotension; Infrequent: bradycardia, angina pectoris, atrial fibrillation; Rare: first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis.</p>
<p>Digestive System: Frequent: anorexia, vomiting; Infrequent: rectal hemorrhage, dysphagia, tongue edema; Rare: gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena.</p>
<p>Endocrine: Rare: hypothyroidism, hyperthyroidism, thyroiditis.</p>
<p>Hemic and Lymphatic System: Infrequent: anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy; Rare: thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia.</p>
<p>Metabolic and Nutritional Disorders: Infrequent: thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia; Rare: BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemic reaction, hypomagnesemia, ketosis, respiratory alkalosis.</p>
<p>Musculoskeletal System: Frequent: myalgia; Infrequent: tenosynovitis; Rare: myopathy.</p>
<p>Nervous System: Frequent: agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy; Infrequent: paralysis; Rare: myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus.</p>
<p>Respiratory System: Frequent: dyspnea; Infrequent: pneumonia, epistaxis; Rare: hemoptysis, laryngismus.</p>
<p>Skin and Appendages: Infrequent: maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash.</p>
<p>Special Senses: Frequent: fungal dermatitis; Infrequent: conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia; Rare: eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis.</p>
<p>Urogenital System: Infrequent: impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention, metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria; Rare: gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage.</p>
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