[tri-med] Re: Strattera Side Effects Update

Many thanks to Fawna and Penny for doing all the leg work and finding 
out about Strattera. What a boon to this list you both are.

At 10:08 AM 28/06/2007, you wrote:
>I finally got a 2 page letter from Eli Lilley Co regarding Penny's Vision
>concerns, and their 26 page "official" report on the known & suspected side
>effects of Strattera.
>
>According to the company's letter to me:
>
>"The event maps to the MedDRA term(s) of: blindness, transient blindness,
>tunnel vision and blurred vision."
>
>"The MedDRA term(s) mentioned above have been rarely reported in the
>spontaneous
>adverse event database, which is defined as an adverse event that occurs at
>an
>estimated rate of less than 0.01% according to the reporting system
>information.
>These data do not represent the rate of occurrence for an adverse event in a
>treated population; they merely represent the rate of reporting of a
>particular
>adverse event to the company."
>
>"This information was valid for data received up through November 26, 2005."
>
>So Annie, your brand new 2007 Nursing Drug book, may not list these vision
>problems as a possible side effect, but the company has known about them for
>at
>least a year and a half now.
>
>Penny and I are both of the opinion that if parents actually read even a
>portion
>of this 26 page report there wouldn't be nearly as many kids taking this
>drug as
>there currently are.  And it doesn't even mention the vision problems above
>in
>their letter either.
>
>Some hi-lites from the report:
>
>Page #2
>
>"...a half life of about 5 hours.  A fraction of the population (about 7% of
>Caucasians and 2% of African Americans) are poor metabolizers (PMs) of
>CYP2D6
>metabolized drugs" (i.e. Strattera). "These individuals have reduced
>activity in
>this pathway resulting in...5-fold higher peak plasma concentrations, and
>slower
>elimination (plasma half-life of about 24 hours)...compared with people with
>normal activity..."
>
>This could mean that IF Devon is a "poor metabolizer" (and the odds of that
>are
>pretty darn good as unfortunately we all know who have one of these
>kiddo's), he
>would have been getting his next dose of Strattera just about the time the
>previous
>one had only just hit the half-life mark.  So Lord only knows just how much
>"over
>medicated" his blood levels rose to over the course of these weeks of
>Strattera
>trial.  Upping his odds of course for developing an "adverse event".
>
>Page #6
>
>Talking about ADHD treatment: "Drug treatment may not be indicated for all
>patients
>with this syndrome." And "The effectiveness of Strattera for long-term use,
>i.e.,
>for more than 9 weeks in a child and adolescent patients and 10 weeks in
>adult
>patients, has not been systematically evaluated in controlled trials.
>Therefore,
>the physician who elects to use Strattera for extended periods should
>periodically
>reevaluate the long-term usefulness of the drug for the individual
>patient..."
>
>Page #7
>
>"Narrow Angle Glaucoma
>In clinical trials, Strattera use was associated with an increase risk of
>mydriasis"
>(abnormal dilation of the pupil) "and therefore its use is not recommended
>in
>patients with narrow angle glaucoma."
>
>The reason I included the above quote is because Penny and I think it may
>well be
>relevant in Devon's case.  Not that he necessarily has Narrow Angle
>Glaucoma, as
>he's never actually been tested for it, but that we think the drug may be
>effecting
>his pupil dilation.  Devon actually appears to have the "transient
>blindness" listed
>in Lilley's letter to me.  Some times, as in last Saturday morning, he seems
>to see
>just fine, but at others he appears to have suffered a total or partial set
>back.
>However, we think those set backs may just be only after he's been outside
>in bright
>sunlight.  Time will tell.
>
>Page #8
>
>"Postmarking reports indicate that Strattera can cause severe liver injury
>in rare
>cases.  Although no evidence of liver injury was detected in clinical trials
>of about
>6000 patients, there have been two reported cases of markedly elevated
>hepatic enzymes
>and bilirubin, in the absence of other obvious explanatory factors, out of
>more than 2
>million patients during the first two years of postmarketing
>experience...and was
>followed by recovery upon drug discontinuance providing evidence that the
>Strattera
>caused the liver injury...laboratory abnormalities may continue to worsen
>for several
>weeks after drug is stopped...The patients described above recovered from
>liver injury,
>and did not require a liver transplant.  However, in a small percentage of
>patients,
>severe drug-related liver injury may progress to acute liver failure
>resulting in death
>or the need for a liver transplant."
>
>The "good news" there is that even the postmarketing patients that they've
>seen thus far
>who have developed "serious liver injury" totally recovered after the drug
>was discontinued.
>So, there IS an excellent chance that Devon will eventually regain his lost
>vision too
>once the drug is totally out of his system.
>
>I'm not going to go into all of the "Serious Cardiac Events" for children &
>adolescents
>also listed on this page, but this is part of the reason why I will NEVER
>let Miss P's
>neuro talk me into a Strattera trial.
>
>Pages #9 & 10
>
>Under "Precautions", "General" talks about the pediatric increases in both
>systolic &
>diastolic blood pressures as well as heart rate.
>
>"At the final study visit before drug discontinuance, 3.6% of
>Strattera-treated subjects
>had heart rate increases of at least 25 beats/minute and a heart rate of at
>least 110
>beats/minute...The mean heart rate increase...in poor metabolizer (PM)
>patients 10.4
>beat/minute."
>
>They do make a point of stressing that "no pediatric patients had these
>measurements at
>more then one visit", but considering it was "the last visit" that's not
>really saying
>much!  And...
>
>"At the final study visit before drug discontinuance, 6.8% of
>Strattera-treated
>pediatric subjects had high systolic blood pressure measurements...,
>2.8%...had high
>diastolic blood pressure measurements...(High systolic and diastolic blood
>pressure
>measurements were defined as those exceeding the 95th percentile, stratified
>by age,
>gender, and height percentile - National High Blood Pressure Education
>Working Group
>on Hypertension Control in Children and Adolescents.)"
>
>"Effects on Growth --- ...In general, the weight and height gain of
>pediatric patients
>treated with Strattera lags behind that predicted by normative population
>data for the
>first 9-12 months of treatment.  Subsequently, weight gain rebounds and at
>about 3 years
>of treatment, patients treated with Strattera have gained 17.9 kg on
>average, 0.5 kg
>more than predicted by their baseline data.  After about 12 months, gains in
>height
>stabilizes, and at 3 years, patients treated with Strattera have gained 19.4
>cm on
>average, 0.4 cm less than predicted by their baseline data."
>
>So it appears Strattera stunts their growth and adds weight in addition to
>everything
>else!
>
>Page #11
>
>"Priapism"
>
>Do we all recognize this term for the Cialis commercials?
>
>"Rare postmarketing cases of priapism, defined as painful and nonpainful
>penile erection
>lasting more than 4 hours, have been reported for pediatric and adult
>patients treated
>with Strattera.  The erections resolved in cases in which follow-up
>information was
>available, some following discontinuance of Strattera.  Prompt medical
>attention is
>required in the event of suspected priapism."
>
>Gee folks, don't we all just want our male pediatric triers sent home from
>school with a
>nurse's note on this one?
>
>Page #12
>
>"Strattera is an ocular irritant.  Strattera capsules are not intended to be
>opened.  In
>the event of capsule content coming in contact with the eye, the effected
>eye should be
>flushed immediately with water, and medical advice obtained."
>
>It is stressed repeatedly in the literature that capsules are NOT to be
>opened, making it
>harder to administer to rare trisomy patients.
>
>Also under "Laboratory Tests".  "Routine laboratory tests are not required."
>
>Now that's a scary comment, considering the possibility of "severe liver
>injury" listed
>back on page #8!
>
>Pages #13 & 14 relate to animal testing.  They were of course given higher
>doses/per body
>weight then would be 'normal' in human subjects.  But I'm not sure how that
>relates to
>the dose given to poor metabolizers who have residuals.
>
>"Mutagenesis ---...there was a slight increase in the percentage of Chinese
>hamster ovary
>cells with diplochromosomes, suggesting endoreduplication (numerical
>aberration)."
>
>Chromosomal abnormalities!
>
>"Pregnant rabbits...a decrease in live fetuses...Slight increases in the
>incidence of
>atypical origin of carotid artery and absence of subclavian artery were
>observed."
>
>Increased stillbirths & blood vessel defects in offspring!
>
>"Rats...lactation...decreases in pup weight and pup survival were observed.
>In a study
>in which rats were treated with atomoxetine" (the main component of
>Strattera) "in the
>diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout
>the period
>of organogenesis, a decrease in fetal weight (female only) and an increase
>in the
>incidence of incomplete ossification of the vertebral arch in fetuses were
>observed...
>No adequate and well-controlled studies have been conducted in pregnant
>women.
>Strattera should not be used during pregnancy unless the potential benefit
>justifies
>the potential risk to the fetus."
>
>"Pediatric Use"
>"The efficacy of Strattera beyond 9 weeks and the safety of Strattera beyond
>1 year of
>treatment have not been systematically evaluated."
>
>Page #15
>
>"Strattera was administered to 2067 children or adolescent patients with
>ADHD and 270
>adults with ADHD in clinical studies."
>
>Under "Reasons for discontinuation of treatment due to adverse events in
>children and
>adolescent clinical trials --- ...For all studies,...5% of extensive
>metabolizer (EM)
>patients and 7% of poor metabolizer (PM) patients discontinued because of
>adverse event.
>
>"Strattera has not been systematically evaluated in pediatric patients with
>seizure
>disorder as these patients were excluded from clinical studies during the
>product's
>premarketing testing...In these clinical trials, the seizure risk among poor
>metabolizers was 0.3% compared to 0.2% for extensive metabolizers.
>
>Page #19
>
>"The following postmarketing adverse events have been reported in temporal
>association
>with Strattera treatment and were not associated with Strattera use during
>the pre-
>marketing evaluation of Strattera.  Given the limitations associated with
>spontaneous
>reporting, it is difficult to accurately estimate the incidence rates for or
>causality
>of these events...Cardiovascular System ---QT prolongation, syncope.
>Seizures ---
>Seizures have been reported in the postmarketing period.  The post marketing
>seizure
>cases include patients with pre-existing seizure disorders and those with
>identified
>risk factors for seizures, as well as patients with neither a history of nor
>identified
>risk factors for seizures."
>
>Page #20
>
>"There was no evidence of symptom rebound or adverse events suggesting a
>drug
>discontinuation or withdrawal syndrome."
>
>So yes, it IS evidently safe to abruptly stop this drug!  And...
>
>"In some cases of overdose involving Strattera, seizures have been
>reported."
>
>Page #22
>
>"1. Suicidal thoughts and actions in children and teenagers:...Although no
>suicides
>occurred in these studies, 4 out of every 1000 patients developed suicidal
>thoughts."
>
>Page #23
>
>"3. Heart rate problems: sudden death in patients who have heart problems or
>heart
>defects..."
>
>"4. New mental (psychiatric) problems in children and teenagers: new
>psychotic symptoms
>(such as hearing voices, believing things are not true, being suspicious) or
>new manic
>symptoms"
>
>Page #24
>
>"Do not chew, crush, or open the capsules.  Swallow Strattera capsules whole
>with water
>or other liquids.  Tell your doctor if you or your child cannot swallow
>Strattera whole.
>A different medicine may need to be prescribed."
>
>Any takers?
>
>Fawna, Research coordinator TRIS Project, mom
>to Thom & Rhonda, Lara, & Philina 24yrs (PT6p
>& Moya Moya Syndrome), Escondido, CA USA
>http://home.mindspring.com/~fawna33/
>
>
>
>
>
>
>
>
>
>
>                   Building ___ooOOoo__ Rainbows
>                        www.trisomyonline.org
>                   Families Helping Families On-line
>
>
>
>
>--
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>27/06/2007 9:08 PM

Jocelyn, Wife to Frank, Mother to Ian, Gillian & Susan. Maker of 
quilts, singer of songs,
Nanna to Carly 20, Mathew 18, Ashleigh 17, Alex 15, and Tess 10 years 
old with T18.
also step Nanna to Carrie age 19. & Great Grandmother to Eli, Jonas & Escha.
Living in NSW, Australia 

                  Building ___ooOOoo__ Rainbows
                       www.trisomyonline.org
                  Families Helping Families On-line

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