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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by JANNBEAU on April 4, 2002, at 10:05:30
Hello, All:
I just picked this information up from the FDA's passive surveillance system for drugs. Combining certain drugs with Geodon can have life-threatening consequences. Give this information to your physician or pdoc at your first opportunity!. The whole letter from FDA and Pfizer is below.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#geodon
IMPORTANT PRESCRIBING INFORMATION
Geodon (ziprasidone HCl) Capsules were approved on February 5, 2001. Since Geodon's approval, 563,000 prescriptions have been written and 156,000 individual patients have received Geodon. The postmarketing experience has been consistent with the clinical database, and not unexpected in this patient population.
This communication is to inform healthcare professionals about clarifications to the labeling for Geodon capsules. The revisions, made in consultation with the Food and Drug Administration, clarify information that had already been included in the package insert. The Contraindications section included a list of seven drugs contraindicated with ziprasidone and stated that this list of drugs was "not a complete list". Not all physicians, pharmacists and pharmacy databases interpreted this language as intended. Some may have considered certain drugs excluded from the contraindication, while others believed that, irrespective of the level of documentation, any drug associated with QT-prolongation was contraindicated with ziprasidone. Pfizer and FDA agreed there was a need to provide greater clarity around the particular drugs or types of drugs that are contraindicated with Geodon.
The key sections that have been changed in the Geodon label are provided below, and the full prescribing information is enclosed.CONTRAINDICATIONS
QT Prolongation Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, or tacrolimus. Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning (see WARNINGS).WARNINGS
QT Prolongation and Risk of Sudden Death
Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval (see CONTRAINDICATIONS, and see Drug Interactions under PRECAUTIONS). Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. Such drugs should not be prescribed with ziprasidone. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias (see CONTRAINDICATIONS).Cheers,
Jannbeau
Posted by Elizabeth on April 5, 2002, at 9:03:20
In reply to Geodon Warning from FDA: Please Read, posted by JANNBEAU on April 4, 2002, at 10:05:30
This type of electrocardiographic side effect is actually pretty common, especially with certain drug combinations. It's something to take into account if you're thinking of taking TCAs or neuroleptics.
-elizabeth
Posted by Sunnely on April 5, 2002, at 21:52:54
In reply to Geodon Warning from FDA: Please Read, posted by JANNBEAU on April 4, 2002, at 10:05:30
The main focus of attention concerning the safety of ziprasidone (Geodon) is the issue of prolongation of the QTc interval of the electrocardiogram (ECG). The FDA initially rejected Pfizer's application because they wanted more information about Geodon's tendency to prolong the QTc. Since then, much has been learned about QTc prolongation associated with antipsychotics in general and with Geodon in particular.
The QTc interval is the length of time it takes the ventricles to electrically discharged and repolarize. A prolongation of the QTc interval can lead to heart arrhythmias, including "torsade des pointes" and other life-threatening arrhythmias. The QTc interval is measured in milliseconds (msec). The subscript "c" indicates that the QT interval has been corrected for the patient's heart rate. The French phrase, "torsades de pointes," meaning "twisted point," is used to described the appearance of this type of rhythm disturbance on the ECG tracing.
Many drugs prolong the QTc to a greater or lesser extent. Haloperidol (Haldol) is an example of a drug that is generally not felt to be a risk factor for torsades de pointes under usual clinical conditions. The following is a general guideline prior to prescribing Geodon.
GEODON PRE-TREATMENT SCREENING:
A. If the answer is "Yes" to any of the following conditions, do not give Geodon:
1. Recent heart attack
2. Uncompensated congestive heart failure
3. History of heart arrhythmia, heart block, or slow heart rate
4. Myocarditis
5. Idiopathic cardiomyopathy
6. Congenital long QT syndrome (born with this condition)
7. Taking drugs that prolong QTc (See list below)B. If the answer is "Yes" to any of the following conditions, get an ECG. Do not give Geodon if QTc is greater than 470 msec:
1. History of palpitations, lightheadedness, syncope (passing out), rapid heart rate
C. If the answer is "Yes" to any of the following conditions, get blood levels of potassium and magnesium, and an ECG. Supplement low potassium and/or magnesium, if needed. Do not give Geodon if QTc is greater than 470 msec:
1. History of eating disorders (anorexia, bulimia)
2. State of dehydration, vomiting, diarrhea
3. Taking diuretics
4. History of alcohol abuse or dependence
5. ElderlyNOTE: The safety and effectiveness of Geodon in children has not been established.
D. Drugs that can prolong QTc:
1. Psychotropic Drugs:
a. Chlorpromazine (Thorazine)
b. Thioridazine (Mellaril)
c. Mesoridazine (Serentil)
d. Pimozide (Orap)
e. Intravenous haloperidol (Haldol)
f. Droperidol (Inapsine)2. Antibiotic Drugs:
a. Gatifloxacin (Tequin)
b. Grepafloxacin (Raxar)
c. Levofloxacin (Levaquin)
d. Moxifloxacin (Avelox)
e. Sparfloxacin (Zagam)
f. Quinupristin/dalfopristin (Synercid I.V.)3. Anti-arrhythmic Drugs:
a. Amiodarone (Cordarone)
b. Disopyramide (Norpace)
c. Dofetilide (Tikosyn)
d. Flecainide (Tambocor)
e. Ibutilide (Corvert)
f. Moricizine (Ethmozine)
g. Procainamide (Procan, Pronestyl)
h. Quinidine (Cardioquin, Quinidex, Quinaglute)
i. Sotalol (Betapace)
j. Tocainide (Tonocard)4. Miscellaneous Drugs:
a. Arsenic trioxide (Trisenox) - anti-cancer (leukemia)
b. Astemizole (Hismanal) - nonsedating antihistmaines; off the market
c. Bepridil (Vascor) - anti-angina
d. Cisapride (Propulsid) - for esophageal reflux (GERD); off the market
e. Dolasetron mesylate (Anzernet) - anti-emetic
f. Fosphenytoin (Cerebryx) - anti-epileptic
g. Halofantrine (Halfan) - anti-malarial infection
h. Indapamide (Lozol) - for high blood pressure, congetive heart failure; may cause low potassium level
i. Isradipine (Dynacirc) - for high blood pressure
j. Levomethadyl (Orlaam) - opiate agonist
k. Mefloquine (Lariam) - anti-malarial infection
l. Nicardipine (Cardene) - for high blood pressure
m. Pentamidine (Pentam) - for pneumocystis pneumonia
n. Probucol (Lorelco) - for high cholesterol
o. Tacrolimus (Prograf) - anti-organ rejection
p. Terfenadine (Seldane) - nonsedating antihistamine; off the market
q. Tizanidine (Zanaflex) - muscle relaxantE. Patients who are taking Geodon are advised to:
1. Immediately report to their physician episode of rapid heart rate, lightheadedness, palpitations, syncope, vomiting or diarrhea, or other illness that can cause loss of fluids.
2. Notify physician before taking any prescription, over-the-counter drugs, or herbal preparations.
3. Avoid excessive use of alcohol.
> Hello, All:
>
> I just picked this information up from the FDA's passive surveillance system for drugs. Combining certain drugs with Geodon can have life-threatening consequences. Give this information to your physician or pdoc at your first opportunity!. The whole letter from FDA and Pfizer is below.
>
> http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#geodon
>
> IMPORTANT PRESCRIBING INFORMATION
> Geodon (ziprasidone HCl) Capsules were approved on February 5, 2001. Since Geodon's approval, 563,000 prescriptions have been written and 156,000 individual patients have received Geodon. The postmarketing experience has been consistent with the clinical database, and not unexpected in this patient population.
> This communication is to inform healthcare professionals about clarifications to the labeling for Geodon capsules. The revisions, made in consultation with the Food and Drug Administration, clarify information that had already been included in the package insert. The Contraindications section included a list of seven drugs contraindicated with ziprasidone and stated that this list of drugs was "not a complete list". Not all physicians, pharmacists and pharmacy databases interpreted this language as intended. Some may have considered certain drugs excluded from the contraindication, while others believed that, irrespective of the level of documentation, any drug associated with QT-prolongation was contraindicated with ziprasidone. Pfizer and FDA agreed there was a need to provide greater clarity around the particular drugs or types of drugs that are contraindicated with Geodon.
> The key sections that have been changed in the Geodon label are provided below, and the full prescribing information is enclosed.
>
> CONTRAINDICATIONS
> QT Prolongation Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, or tacrolimus. Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning (see WARNINGS).
>
> WARNINGS
> QT Prolongation and Risk of Sudden Death
> Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval (see CONTRAINDICATIONS, and see Drug Interactions under PRECAUTIONS). Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. Such drugs should not be prescribed with ziprasidone. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias (see CONTRAINDICATIONS).
>
> Cheers,
> Jannbeau
Posted by Sunnely on April 5, 2002, at 21:59:07
In reply to Geodon Warning from FDA: Please Read, posted by JANNBEAU on April 4, 2002, at 10:05:30
Posted by JANNBEAU on April 8, 2002, at 10:06:54
In reply to Re: Geodon Warning from FDA: Please Read » JANNBEAU, posted by Sunnely on April 5, 2002, at 21:52:54
> Thank you, Sunnely! Stunning Post!! The information you have provided is essential for safety. I thought that, since FDA's Medwatch thought it important enough to post, that those who do or who are contemplating taking the medication should be aware of the possibility of life-threatening side effects. Unfortunately, it has been my experience that many physicians do not know of or simply disregard important side effects of medications, thinking, perhaps, that because they are unusual and the probability is statistically low, that their patients won't be affected--bad move!! But, because of these attitudes, our best defense as patients is to know as much as possible about our conditions and the medications we may be asked to take. It's all a crap shoot because the studies required by FDA are not adequate to pick up unusual or rare events, which makes us all guinea pigs for effects that can only be determined in after-market passive surveillance, which is poor to say the least, as only a small percentage of adverse events are connected to a drug and even fewer are reported.
The information in your post makes it easier for those affected or their loved ones making decisions to make an informed choice of medications.
Again, Thanks for caring enough to gather the information and present an explication of the FDA's warning.
Cheers,
JannbeauThe main focus of attention concerning the safety of ziprasidone (Geodon) is the issue of prolongation of the QTc interval of the electrocardiogram (ECG). The FDA initially rejected Pfizer's application because they wanted more information about Geodon's tendency to prolong the QTc. Since then, much has been learned about QTc prolongation associated with antipsychotics in general and with Geodon in particular.
>
> The QTc interval is the length of time it takes the ventricles to electrically discharged and repolarize. A prolongation of the QTc interval can lead to heart arrhythmias, including "torsade des pointes" and other life-threatening arrhythmias. The QTc interval is measured in milliseconds (msec). The subscript "c" indicates that the QT interval has been corrected for the patient's heart rate. The French phrase, "torsades de pointes," meaning "twisted point," is used to described the appearance of this type of rhythm disturbance on the ECG tracing.
>
> Many drugs prolong the QTc to a greater or lesser extent. Haloperidol (Haldol) is an example of a drug that is generally not felt to be a risk factor for torsades de pointes under usual clinical conditions. The following is a general guideline prior to prescribing Geodon.
>
> GEODON PRE-TREATMENT SCREENING:
>
> A. If the answer is "Yes" to any of the following conditions, do not give Geodon:
>
> 1. Recent heart attack
> 2. Uncompensated congestive heart failure
> 3. History of heart arrhythmia, heart block, or slow heart rate
> 4. Myocarditis
> 5. Idiopathic cardiomyopathy
> 6. Congenital long QT syndrome (born with this condition)
> 7. Taking drugs that prolong QTc (See list below)
>
> B. If the answer is "Yes" to any of the following conditions, get an ECG. Do not give Geodon if QTc is greater than 470 msec:
>
> 1. History of palpitations, lightheadedness, syncope (passing out), rapid heart rate
>
> C. If the answer is "Yes" to any of the following conditions, get blood levels of potassium and magnesium, and an ECG. Supplement low potassium and/or magnesium, if needed. Do not give Geodon if QTc is greater than 470 msec:
>
> 1. History of eating disorders (anorexia, bulimia)
> 2. State of dehydration, vomiting, diarrhea
> 3. Taking diuretics
> 4. History of alcohol abuse or dependence
> 5. Elderly
>
> NOTE: The safety and effectiveness of Geodon in children has not been established.
>
> D. Drugs that can prolong QTc:
>
> 1. Psychotropic Drugs:
> a. Chlorpromazine (Thorazine)
> b. Thioridazine (Mellaril)
> c. Mesoridazine (Serentil)
> d. Pimozide (Orap)
> e. Intravenous haloperidol (Haldol)
> f. Droperidol (Inapsine)
>
> 2. Antibiotic Drugs:
> a. Gatifloxacin (Tequin)
> b. Grepafloxacin (Raxar)
> c. Levofloxacin (Levaquin)
> d. Moxifloxacin (Avelox)
> e. Sparfloxacin (Zagam)
> f. Quinupristin/dalfopristin (Synercid I.V.)
>
> 3. Anti-arrhythmic Drugs:
> a. Amiodarone (Cordarone)
> b. Disopyramide (Norpace)
> c. Dofetilide (Tikosyn)
> d. Flecainide (Tambocor)
> e. Ibutilide (Corvert)
> f. Moricizine (Ethmozine)
> g. Procainamide (Procan, Pronestyl)
> h. Quinidine (Cardioquin, Quinidex, Quinaglute)
> i. Sotalol (Betapace)
> j. Tocainide (Tonocard)
>
> 4. Miscellaneous Drugs:
> a. Arsenic trioxide (Trisenox) - anti-cancer (leukemia)
> b. Astemizole (Hismanal) - nonsedating antihistmaines; off the market
> c. Bepridil (Vascor) - anti-angina
> d. Cisapride (Propulsid) - for esophageal reflux (GERD); off the market
> e. Dolasetron mesylate (Anzernet) - anti-emetic
> f. Fosphenytoin (Cerebryx) - anti-epileptic
> g. Halofantrine (Halfan) - anti-malarial infection
> h. Indapamide (Lozol) - for high blood pressure, congetive heart failure; may cause low potassium level
> i. Isradipine (Dynacirc) - for high blood pressure
> j. Levomethadyl (Orlaam) - opiate agonist
> k. Mefloquine (Lariam) - anti-malarial infection
> l. Nicardipine (Cardene) - for high blood pressure
> m. Pentamidine (Pentam) - for pneumocystis pneumonia
> n. Probucol (Lorelco) - for high cholesterol
> o. Tacrolimus (Prograf) - anti-organ rejection
> p. Terfenadine (Seldane) - nonsedating antihistamine; off the market
> q. Tizanidine (Zanaflex) - muscle relaxant
>
> E. Patients who are taking Geodon are advised to:
>
> 1. Immediately report to their physician episode of rapid heart rate, lightheadedness, palpitations, syncope, vomiting or diarrhea, or other illness that can cause loss of fluids.
> 2. Notify physician before taking any prescription, over-the-counter drugs, or herbal preparations.
> 3. Avoid excessive use of alcohol.
>
>
> > Hello, All:
> >
> > I just picked this information up from the FDA's passive surveillance system for drugs. Combining certain drugs with Geodon can have life-threatening consequences. Give this information to your physician or pdoc at your first opportunity!. The whole letter from FDA and Pfizer is below.
> >
> > http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#geodon
> >
> > IMPORTANT PRESCRIBING INFORMATION
> > Geodon (ziprasidone HCl) Capsules were approved on February 5, 2001. Since Geodon's approval, 563,000 prescriptions have been written and 156,000 individual patients have received Geodon. The postmarketing experience has been consistent with the clinical database, and not unexpected in this patient population.
> > This communication is to inform healthcare professionals about clarifications to the labeling for Geodon capsules. The revisions, made in consultation with the Food and Drug Administration, clarify information that had already been included in the package insert. The Contraindications section included a list of seven drugs contraindicated with ziprasidone and stated that this list of drugs was "not a complete list". Not all physicians, pharmacists and pharmacy databases interpreted this language as intended. Some may have considered certain drugs excluded from the contraindication, while others believed that, irrespective of the level of documentation, any drug associated with QT-prolongation was contraindicated with ziprasidone. Pfizer and FDA agreed there was a need to provide greater clarity around the particular drugs or types of drugs that are contraindicated with Geodon.
> > The key sections that have been changed in the Geodon label are provided below, and the full prescribing information is enclosed.
> >
> > CONTRAINDICATIONS
> > QT Prolongation Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, or tacrolimus. Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning (see WARNINGS).
> >
> > WARNINGS
> > QT Prolongation and Risk of Sudden Death
> > Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval (see CONTRAINDICATIONS, and see Drug Interactions under PRECAUTIONS). Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. Such drugs should not be prescribed with ziprasidone. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias (see CONTRAINDICATIONS).
> >
> > Cheers,
> > Jannbeau
Posted by JANNBEAU on April 8, 2002, at 10:10:10
In reply to Add tricyclic antidepressants (TCAs) to psych meds (nm) » JANNBEAU, posted by Sunnely on April 5, 2002, at 21:59:07
Thought so, Sunnely! Thanks,
Jannbeau
This is the end of the thread.
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