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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 33. This is the beginning of the thread.
Posted by Squiggles on August 31, 2007, at 14:21:38
I'n not against pharmacotherapy as first
line treatment for affective illnesses,
but i have noticed a lot of the new drugs
coming out have warnings attached to them that
the old ones do not. Serzone is an example, but
Dr. Preskorn offered an enzyme or protein test
for genetic vulnerability before prescribing it.The newest one i see is:
http://www.zyprexaupdates.com/settlement/about.jsp?ccd=zyprxlit119
What's going on -- are the tests more discriminating or the drugs more dangerous?
p.s. sorry if i posted this on the wrong file--maybe pharmacology;
Squiggles
Posted by sam123 on August 31, 2007, at 14:32:11
In reply to More and more warnings with new drugs, posted by Squiggles on August 31, 2007, at 14:21:38
> The newest one i see is:
>
> http://www.zyprexaupdates.com/settlement/about.jsp?ccd=zyprxlit119
>
> What's going on -- are the tests more discriminating or the drugs more dangerous?
>
>
Hmm, what is new here ? except for Cerebrovascular adverse events in elderly patients with dementia-related psychosis, where ZYPREXA is not approved for the treatment of elderly patients with dementia-related psychosis, there is nothing new.For the side effects listed on that page, except the above, all are found in other antipsychotics.
Neuroleptic malignant syndrome, Tardive dyskinesia, Orthostatic hypotension, and Seizures
can happen even the oldest antipsychotics.
The rest are seen in the newer ones.What it new here ?
Posted by Squiggles on August 31, 2007, at 14:41:09
In reply to Re: More and more warnings with new drugs, posted by sam123 on August 31, 2007, at 14:32:11
I suppose what's new is that older drugs had
no such warnings-- maybe there were no tests
or reports. The FDA must have comparative statistics going back to Haldol on antipsychotics.
Seizure, stroke, malignant syndrome -- i don't recall "Mad in America" reporting such huge dangers in the older drugs (only tardive dyskinesia), or Healy's books for that matter. Maybe they are new.Squiggles
Posted by sam123 on August 31, 2007, at 14:45:59
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on August 31, 2007, at 14:41:09
Here is a part of a monograph for an old AP, Mellaril:
PrecautionsCaution is required in patients with narrow-angle glaucoma, prostatic hypertrophy, or ***cardiovascular disease (severe cardiovascular disease is a contraindication)**.
***Hypotension (which is usually orthostatic)** may occur, especially in females, the elderly, and in alcoholic patients. The administration of epinephrine should be avoided in the treatment of drug-induced hypotension in view of the fact that phenothiazines may induce a reverse-epinephrine effect.
As with other phenothiazines, benign repolarization changes such as prolongation of the Q-T interval, flattening of the T wave and the appearance of a U wave have been reported. These changes are usually confined to high doses and are more likely to occur when potassium blood levels are low. Like all phenothiazines, thioridazine may induce arrhythmias.
Sudden and unexplained death, apparently due to arrhythmias or cardiac arrest, has been reported. Previous brain damage or seizures may also be predisposing factors. High doses should be avoided in patients with a history of seizures.
****Convulsive seizures**** have been reported but are infrequent. However, thioridazine has been shown to be helpful in the treatment of behavioral disorders in epileptic patients. In such cases, anticonvulsant medication should be continued and dosage adjustment considered (see Drug Interactions).
Leukopenia and agranulocytosis have been reported but are infrequent. A complete blood count is recommended before the initiation of therapy, especially if long-term treatment is anticipated. Blood counts should be carried out regularly during the first few months of therapy and should be done immediately whenever clinical signs suggestive of blood dyscrasia occur.
Pigmentary retinopathy has been observed after long-term treatment, mostly in patients receiving doses exceeding the recommended maximum of 800 mg/day. Patients receiving higher doses of phenothiazines for prolonged periods should have complete eye examinations at regular intervals.
In patients with liver disease, regular monitoring of liver function is necessary.
Occupational Hazards:
Where patients are participating in activities requiring complete mental alertness (e.g. driving vehicles, operating machinery), administer the phenothiazine cautiously since impairment of reactions may occur with large doses and during early treatment.Pregnancy and Lactation:
Safe use of thioridazine in human pregnancy has not been established. Therefore, it should not be administered to pregnant women (particularly during the first trimester of pregnancy) unless the expected benefit to the patient clearly outweighs the potential risk to the fetus. Thioridazine may appear in human breast milk and therefore mothers receiving this drug should not breast-feed.Children:
Thioridazine should be kept out of the reach of children.Drug Interactions:
Phenothiazines may enhance the CNS-depressant effects of alcohol, antihistamines and other CNS depressants as well as atropine and phosphorus insecticides; the antimuscarinic effects of anticholinergic agents; and the inhibitory cardiac effects of quinidine.Use of epinephrine in the treatment of phenothiazine-induced hypotension may induce a reverse-epinephrine effect.
Phenothiazines may reduce the antiparkinsonian effects of levodopa.
Phenothiazines may ***lower the seizure threshold in epileptic patients****. Dosage adjustment of anticonvulsant medication may be necessary.
Owing to their adrenolytic action, phenothiazines may reduce the pressor effect of adrenergic vasoconstrictors.
Concurrent use with MAO inhibitors may prolong and intensify the sedative and antimuscarinic effects of phenothiazines.
Concomitant use of lithium may aggravate ****extrapyramidal symptoms**** and neurotoxicity caused by neuroleptic agents. Early signs of lithium toxicity may be masked by the antiemetic effect of phenothiazines.
Posted by sam123 on August 31, 2007, at 14:50:28
In reply to Re: More and more warnings with new drugs, posted by sam123 on August 31, 2007, at 14:45:59
Here is an old AP, Navane:
****Cardiovascular Effects****: Tachycardia, hypotension, lightheadedness, and syncope. In the event hypotension occurs, epinephrine should not be used as a pressor agent since a paradoxical further lowering of blood pressure may result. Nonspecific EKG changes have been observed in some patients receiving Navane. These changes are usually reversible and frequently disappear on continued Navane therapy. The incidence of these changes is lower than that observed with some phenothiazines. The clinical significance of these changes is not known.
CNS Effects: Drowsiness, usually mild, may occur although it usually subsides with continuation of Navane therapy. The incidence of sedation appears similar to that of the piperazine group of phenothiazines but less than that of certain aliphatic phenothiazines. Restlessness, agitation and insomnia have been noted with Navane. ***Seizures*** and paradoxical exacerbation of psychotic symptoms have occurred with Navane infrequently.
Hyperreflexia has been reported in infants delivered from mothers having received structurally related drugs.
In addition, phenothiazine derivatives have been associated with cerebral edema and cerebrospinal fluid abnormalities.
****Extrapyramidal symptoms, such as pseudoparkinsonism, akathisia and dystonia have been reported****. Management of these extra-pyramidal symptoms depends upon the type and severity. Rapid relief of acute symptoms may require the use of an injectable antiparkinson agent. More slowly emerging symptoms may be managed by reducing the dosage of Navane and/or administering an oral antiparkinson agent.
****Persistent Tardive Dyskinesia****: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.
Since early detection of tardive dyskinesia is important, patients should be monitored on an ongoing basis. It has been reported that fine vermicular movement of the tongue may be an early sign of the syndrome. If this or any other presentation of the syndrome is observed, the clinician should consider possible discontinuation of antipsychotic medication. (See WARNINGS section.)
****Hepatic Effects****: Elevations of serum transaminase and alkaline phosphatase, usually transient, have been infrequently observed in some patients. No clinically confirmed cases of jaundice attributable to Navane (thiothixene) have been reported.
Hematologic Effects: As is true with certain other psychotropic drugs, leukopenia and leucocytosis, which are usually transient, can occur occasionally with Navane. Other antipsychotic drugs have been associated with agranulocytosis, eosinophilia, hemolytic anemia, thrombocytopenia and pancytopenia.
Allergic Reactions: Rash, pruritus, urticaria, photosensitivity and rare cases of anaphylaxis have been reported with Navane. Undue exposure to sunlight should be avoided. Although not experienced with Navane, exfoliative dermatitis and contact dermatitis (in nursing personnel) have been reported with certain phenothiazines.
****Endocrine Disorders: Lactation, moderate breast enlargement and amenorrhea**** have occurred in a small percentage of females receiving Navane. If persistent, this may necessitate a reduction in dosage or the discontinuation of therapy. Phenothiazines have been associated with false positive pregnancy tests, gynecomastia, hypoglycemia, hyperglycemia and glycosuria.
Autonomic Effects: Dry mouth, blurred vision, nasal congestion, constipation, increased sweating, increased salivation and impotence have occurred infrequently with Navane therapy. Phenothiazines have been associated with miosis, mydriasis, and adynamic ileus.
Other Adverse Reactions: Hyperpyrexia, anorexia, nausea, vomiting, diarrhea, increase in appetite and weight, weakness or fatigue, polydipsia, and peripheral edema.
Although not reported with Navane, evidence indicates there is a relationship between phenothiazine therapy and the occurrence of a systemic lupus erythematosus-like syndrome.
***Neuroleptic Malignant Syndrome (NMS)***: Please refer to the text regarding NMS in the WARNINGS section.
NOTE: ****Sudden deaths have occasionally been reported in patients who have received certain phenothiazine derivatives****. In some cases the cause of death was apparently cardiac arrest or asphyxia due to failure of the cough reflex. In others, the cause could not be determined nor could it be established that death was due to phenothiazine administration.
Posted by Squiggles on August 31, 2007, at 14:51:51
In reply to Re: More and more warnings with new drugs, posted by sam123 on August 31, 2007, at 14:45:59
OK - thanks for the example. Phenothiazines
bad; antipsychotics themselves are sedating;
hence the low blood pressure and Q-T prolongation (which btw occurs with lithium); interesting that they should use APs for both schizophrenia and bp; are they trying to calm the person down in a sedating manner or actually change the mind state?Squiggles
Posted by Phillipa on August 31, 2007, at 18:23:58
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on August 31, 2007, at 14:51:51
I think when someone is very manic some become psychotic hence an antipsychotic Phillipa
Posted by Squiggles on August 31, 2007, at 19:14:16
In reply to Re: More and more warnings with new drugs » Squiggles, posted by Phillipa on August 31, 2007, at 18:23:58
Hmmm, that would be particularly good
for bipolar manic states. I would be
concerned about giving an AP indefinitely
as the manic state varies greatly in duration.
What would happen when the depressive state
sets in and the patient is still on an AP?I would prefer a strong sedative for a manic
state, and then a mood stabilizer. Infact,
that is exactly how i was treated when i
first was dx'd as bp.Squiggles
Posted by sam123 on September 1, 2007, at 4:41:52
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on August 31, 2007, at 14:51:51
interesting that they should use APs for both schizophrenia and bp; are they trying to calm the person down in a sedating manner
yep. Calming can also include suppressing hallucinations and not just psychotic
and disordered thinking or mania.or actually change the mind state?
>
Hmmm, I am not sure what you mean. If you mean
get at the cause vs. treating symptoms, they
treat symptoms.
For BP, I think lithium and anticonvulsives get at the cause.My point previously in this thread is that, at least with antipsyotics (AP) the side effects today were also seen in the orignal AP's and any AP the followed. They are now being
used for conditions that have no psychotic features.The "new" effects are really just more reporting of side effects, well known at all AP's, in greater numbers due to AP's are now used for several disorders.
AD's have gotten black box warnings for suicide
and that is a well know slight possibility even in the TCA's, our original AD's. The black box on AD's used for children did lower their use but sucide rates went up among children.
Posted by Squiggles on September 1, 2007, at 6:46:01
In reply to Re: More and more warnings with new drugs, posted by sam123 on September 1, 2007, at 4:41:52
I hardly think that antipsychotics are a
good substitute to benzos and mood stabilizers
for bipolar; i know little about schizophrenia
and what it's cause is; sounds like carpet-bombing
pharmacology for APs-- and the side effects
really make you look crazy even if you're not;
you also gain an enormous amount of weight-- maybe
that's where the cardiac problems comes from.Squiggles
Posted by Squiggles on September 1, 2007, at 7:04:15
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on September 1, 2007, at 6:46:01
Just looked them up on Wikipedia, and what
can i say.... i think they and their indiscriminate use really s*ck:
http://en.wikipedia.org/wiki/Antipsychotic#HistoryAnaesthetics is their original chemical formula; yup sedation-- probably better for the the one treating than the one treated especially if the complaints are loud.
Squiggles
Posted by sam123 on September 1, 2007, at 14:33:20
In reply to Re: More and more warnings with new drugs » Squiggles, posted by Squiggles on September 1, 2007, at 7:04:15
> Anaesthetics is their original chemical formula; yup sedation-- probably better for the the one treating than the one treated especially if the complaints are loud.
>
> Squiggles
>
So I take it you prefer to remain awake during painful procedures and surgery ?
Posted by Squiggles on September 1, 2007, at 15:57:25
In reply to Re: More and more warnings with new drugs, posted by sam123 on September 1, 2007, at 14:33:20
It is one thing to be anesthetized for
surgery, and quite another for mood disorders.Squiggles
Posted by sam123 on September 1, 2007, at 16:37:10
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on September 1, 2007, at 15:57:25
> It is one thing to be anesthetized for
> surgery, and quite another for mood disorders.
>
> SquigglesOpps, sorry. I misunderstood you; yes they are quite different.
However I do not think things are black and white concerning AP's. They are very effective for short term use. During a crisis to stop the psychosis or mania. For the positive symptoms of schizophrenia
there are no other medical treatments and AP's are quite effective.
Posted by Squiggles on September 1, 2007, at 16:44:17
In reply to Re: More and more warnings with new drugs, posted by sam123 on September 1, 2007, at 16:37:10
For schizophrenia perhaps; though the actual
understanding of schizophrenia is not yet
complete-- it could be severe anxiety and
there is overlap in these conditions both
in their phenomenology as well as their
neurological underpinnings.But for bipolar disorder (mercifully very
clean and distinct in its presentation) i would
not personally trust someone to give it for
a limited time, and then take you off. I
think expedience might just overcome vigilance
in many of these treatments. This has happened
with the benzo addiction fiasco in the past 20 years of so, and only recently has been admitted
to and become an accepted medical issue. Possibly the same will happen with many other new drugs.Caveat emptor
Squiggles
Posted by sam123 on September 1, 2007, at 17:27:33
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on September 1, 2007, at 16:44:17
> For schizophrenia perhaps; though the actual
> understanding of schizophrenia is not yet
> complete-- it could be severe anxiety and
> there is overlap in these conditions both
> in their phenomenology as well as their
> neurological underpinnings.
>There is overlap every where in mental illness and little is understood about the neurological underpinnings of mental illness. Lots of theories, though. None of this is ever black or white.
Posted by linkadge on September 1, 2007, at 17:50:15
In reply to Re: More and more warnings with new drugs, posted by sam123 on September 1, 2007, at 17:27:33
I agree. Bipolars really get the raw deal.
Mood mood stabilizers are rough, and antipsychotics are no fun as well as not all that safe.
When I was told I would need mood stabilizers, I reluctantly agreed, with no real idea of what I was in for.
Linkadge
Posted by satyam on September 1, 2007, at 18:31:39
In reply to More and more warnings with new drugs, posted by Squiggles on August 31, 2007, at 14:21:38
Human brain is so complex that psychopharmacology needs to advance much more, becuase the present psychotropics try to fix things but mess others hence so many side effects
Posted by Phillipa on September 1, 2007, at 20:09:15
In reply to Re: More and more warnings with new drugs » sam123, posted by Squiggles on September 1, 2007, at 16:44:17
Squiggles comletly agree with you look at vioxx and a bunch of other meds. Phillipa
Posted by Squiggles on September 1, 2007, at 20:24:15
In reply to Re: More and more warnings with new drugs » Squiggles, posted by Phillipa on September 1, 2007, at 20:09:15
The warnings may be more numerous today
for litigious reasons. It may be that
the old drugs also had dangerous side effects
but public organizations, such as 'Public Citizen', 'Mindfreedom' 'Benzo.org' etc. did
not exist and hospital personnel deferred
to authority. People may have died quietly
and mysteriously due to their illness without
acknowledgement of iatrogenic cause. But the
doctors and medical professionals must have known nonetheless.Squiggles
Posted by Phillipa on September 1, 2007, at 21:38:04
In reply to Re: More and more warnings with new drugs » Phillipa, posted by Squiggles on September 1, 2007, at 20:24:15
I believe that a death that occurs in a hospital setting or even at home that shouldn't occur requires an autopsy. The true cause would be known then. Phillipa
Posted by Squiggles on September 1, 2007, at 22:36:14
In reply to Re: More and more warnings with new drugs » Squiggles, posted by Phillipa on September 1, 2007, at 21:38:04
> I believe that a death that occurs in a hospital setting or even at home that shouldn't occur requires an autopsy. The true cause would be known then. Phillipa
That is in an ideal world; in impoverished or
dysfunctional families, you can imagine that
an autopsy request is a luxury. In our privileged
part of the world that is possible with most
families, but i think it is quite beyond the social range of other cultural and economic circles.Squiggles
Posted by Phillipa on September 2, 2007, at 19:41:18
In reply to Re: More and more warnings with new drugs » Phillipa, posted by Squiggles on September 1, 2007, at 22:36:14
Squiggles are you talking about underprivledged places? As I know when my Father died they wanted to do one as he had seen the doc two days prior and had complained of weight gain and difficulty urinating and the doc paid no attention. He died of pulmonary edema. When the hospital called and said it was mandatory I had to put up a fight so none would be done. Didn't want his body cut up. Phillipa
Posted by Squiggles on September 2, 2007, at 20:05:54
In reply to Re: More and more warnings with new drugs » Squiggles, posted by Phillipa on September 2, 2007, at 19:41:18
> Squiggles are you talking about underprivledged places? As I know when my Father died they wanted to do one as he had seen the doc two days prior and had complained of weight gain and difficulty urinating and the doc paid no attention. He died of pulmonary edema. When the hospital called and said it was mandatory I had to put up a fight so none would be done. Didn't want his body cut up. Phillipa
Mostly about poor families who may have
too many problems and obstacles to actually
ask the doctors or be assertive against powers
higher than them. I didn't know that a hospital
conducted them on a mandatory basis-- are you
sure about that? I thought you had to make
a request.I'm sorry about your father's death and the
doctor's indifference to dangerous signs.
Squiggles
Posted by Phillipa on September 2, 2007, at 20:18:00
In reply to Re: More and more warnings with new drugs » Phillipa, posted by Squiggles on September 2, 2007, at 20:05:54
Squiggles since he was diagnosed healthy it throws suspicion on the cause of death. He was living with my sister and family. How would they know if she poisoned him? That's an extreme example. Phillipa
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