DEPRESSION MED: 15 Year Old Hangs Himself: Illinois

FDA ‘black-box’ warning – In 2003, the U.S. Food and Drug Administration began warning of an increased risk of suicidal thoughts among youths taking anti-depressants. In 2004, the agency required a new, more stringent label when antidepressants were prescribed to those under 18.

Between 2003-04 the youth suicide rate jumped 14 percent
– the steepest increase ever seen – while the number of antidepressant prescriptions for youths dramatically dropped during the same period: 20 percent for children 10 and under, 12 percent for 11-to-14-year-olds and 10 percent for 15-to-19-year-olds.

Paragraphs 29 & 30 read: “He stopped going to school and began attending an outpatient program, seeing a therapist and a psychiatrist and taking medication for depression and anxiety. He tried returning to school on a half-day basis, but soon became overwhelmed with makeup work and inquiries from classmates who heard rumors he had tried to kill himself. After a few days in school, Iain asked to be readmitted to the hospital, where he stayed for a week, his parents said.”

“But as summer approached, he began showing signs of improvement. He was easier to communicate with, did his chores when asked and his doctors believed they had found the right balance in his medication, his father said.”

Paragraph 32 reads: “Lain’s parents and friends say they do not know of any incidents that might have triggered what happened June 3, when his father found him in the basement. His death was ruled a suicide by hanging, according to the Cook County Medical Examiner’s Office. He did not leave a note.”

http://www.azcentral.com/news/articles/2009/07/05/20090705bullying.html

Bullied boy’s short life ends in suicide
Jul. 5, 2009 08:20 AM
Associated Press

CHICAGO – The bullying seemed inescapable.

His family and friends say it followed Iain Steele from junior high to high school
– from hallways, where one tormentor shoved him into lockers, to cyberspace, where another posted a video on Facebook making fun of his taste for heavy metal music.

“At one point, (a bully) had told (Iain) he wished he would kill himself,” said Matt Sikora, Iain’s close friend.

Iain’s parents know their son had other problems, but they believe the harassment contributed to a deepening depression that hospitalized the 15-year-old twice this year. On June 3, while his classmates were taking final exams, he went to the basement of his home and hanged himself with a belt.

His death stunned his quiet suburb west of Chicago and unleashed an outpouring of support for his parents, William and Liz, who say greater attention should be paid to bullying and its connection to mental health.

“No kid should be afraid for himself to go to school,” his father said. “It should be a safe environment where they can intellectually thrive. And he was, literally, just frightened to go to school, fearing what he would have to deal with on that day. And it was day after day.”

A school spokeswoman said she did not believe Iain was bullied. Police are investigating the allegations.

Nearly 30 percent of American children are bullied or are bullies themselves, according to the National Youth Violence Prevention Resource Center. Bullying can be physical, verbal or psychological and is repetitive, intentional and creates a perceived imbalance of power, said Dr. Joseph Wright, senior vice president at Children’s National Medical Center in Washington.

Soon, the American Academy of Pediatrics will for the first time include a section on bullying in its official policy statement on the pediatrician’s role in preventing youth violence.

Wright, a lead author of the statement, said the decision to address the issue was due to a growing body of research over the last decade linking bullying to youth violence, depression and suicidal thoughts.

Last year, the Yale School of Medicine conducted analysis of the link between childhood bullying and suicide in 37 studies from 13 countries, finding both bullies and their victims were at high risk of contemplating suicide.

In March, the parents of a 17-year-old Ohio boy who committed suicide filed a lawsuit against his school alleging their son was bullied. Instead of seeking compensation, they are asking the school to put in place an anti-bullying program and to recognize their son’s death as a “bullicide.”

Iain Steele enjoyed riding his skateboard, his father said, but after hip surgery in 8th grade limited his mobility, he picked up the guitar and impressed an instructor with his musical talent.

He was revered by younger kids in the neighborhood, often fixing their skateboards, settling their disputes and including them in games. “He was a very gentle, kind kid, compassionate to a fault,” his father said. But Iain’s embrace of heavy metal set him apart from classmates. He let his hair grow to shoulder-length and wore mostly black clothing, including jeans with chains and T-shirts of heavy metal bands with dark, sometimes morbid lyrics.

For this, his classmates at McClure Junior High School often called him “emo” – a slang term for angst-ridden followers of a style of punk music, said Sikora, 15.

The bullying could also be physical, Iain’s friends and parents said. In 8th grade at McClure, one bully pushed Iain into a locker while he was on crutches and accused him of faking an injury to get out of gym class. Iain rarely shied away from his tormentors, however, and in this case, he punched the bully in the jaw, his father said.

“He was mainly bullied only because he was different, or hurt, or stupid things like that,” said Sikora. “He never bothered anybody. … It was all just because he was different and an easy target.”

William Steele said his son had trouble ignoring the bullying because it “was just sort of relentless.” It got to the point where the father sat down with the principal at McClure and with a bully’s mother. But the harassment did not subside.

Steele said, “(Iain) had a real trust issue because he felt like, particularly at McClure, the system let him down, that it didn’t deliver on its promise to protect him from bullying.”

McClure Principal Dan Chick said in an e-mail “the District 101 community is deeply saddened by this recent tragedy of losing one of our children.” Chick said he takes bullying very seriously but declined to discuss details of Iain’s case because of privacy issues.

“As with all situations, I investigated this specific matter and took appropriate actions within the limits of my authority,” Chick said.

After graduating from McClure in 2008, Iain began attending the south campus for freshmen and sophomores at Lyons Township High School, where he found new friends – and new tormentors. A new bully emerged who at first acted friendly but then posted a homemade video on Facebook pretending to be Iain playing heavy metal on guitar.

“It was like a public humiliation to (Iain),” Sikora said.

The family of the student did not respond to requests for comment.

Jennifer Bialobok, a spokeswoman for Lyons Township High School, said “bullying is obviously not tolerated at LT,” but added, “I don’t think we’re naive enough to think that bullying behavior doesn’t exist.”

Two years ago, Lyons Township created a “speak up line” in which students can anonymously report “inappropriate or unsafe behavior,” and the school hangs posters defining bullying and explaining how to report it, Bialobok said. If any student reported being bullied, a thorough investigation would take place, with consequences ranging from parental notification to out-of-school suspension, she said.

Bialobok said she could not discuss Iain’s case because of student privacy laws, but, “we don’t believe that bullying was an issue while Iain was attending LT. Counselors and a host of other support personnel worked routinely to make his experience at LT a positive one.”

Local police have not documented incidents of bullying involving Iain but are still conducting interviews, Deputy Chief Brian Budds said.

By this winter, Iain’s mental health had begun a downward spiral, his parents said. In February, he told them he was having suicidal thoughts and asked to be admitted to the hospital.

He stopped going to school and began attending an outpatient program, seeing a therapist and a psychiatrist and taking medication for depression and anxiety. He tried returning to school on a half-day basis, but soon became overwhelmed with makeup work and inquiries from classmates who heard rumors he had tried to kill himself. After a few days in school, Iain asked to be readmitted to the hospital, where he stayed for a week, his parents said.

But as summer approached, he began showing signs of improvement. He was easier to communicate with, did his chores when asked and his doctors believed they had found the right balance in his medication, his father said.

“He seemed to be in a calm, happy place,” he said.

Iain’s parents and friends say they do not know of any incidents that might have triggered what happened June 3, when his father found him in the basement. His death was ruled a suicide by hanging, according to the Cook County Medical Examiner’s Office. He did not leave a note.

Looking back, Iain’s parents wonder what factors besides bullying may have contributed to their son’s depression.

Iain’s favorite heavy metal bands, such as Lamb of God and Children of Bodem and Bullet for My Valentine, often have lyrics with dark messages. One Bullet for My Valentine song is about being bullied, and another song contains the refrain: “The only way out is to die.”

Also, Iain was deeply hurt this spring after a brief relationship with a girl he met in his outpatient program. The two exchanged text messages, but her parents and therapists advised against them dating and about two months ago barred her from having communication with him.

Still, Iain’s parents remain convinced bullying played a significant role in their son’s depression. As Iain’s story spread through the community, many people approached Liz Steele to describe their own experiences with bullying, depression or suicide, she said.

“A lot of people don’t want to talk about mental health or bullying because it’s a difficult thing to talk about, but we need to talk about it,” she said. “It shouldn’t be a stigma.”

Meanwhile, the community has rallied behind the Steeles. In Iain’s memory, his classmates tied white ribbons around hundreds of trees in the neighborhood. On June 10, about 500 people attended a memorial service at First Congregational Church of Western Springs.

Rich Kirchherr, senior minister at the church, said the community has felt a “deep and abiding sadness” since Iain’s death. Kirchherr said few people seemed aware that Iain was bullied.

“There is an acknowledgment now, as people have discovered that Iain might not always have been treated with the respect that every person deserves,” Kirchherr said. “Many people were surprised to hear that.”

Friends have established several Facebook groups in his memory, including the “Iain Steele Remembrance Group,” which has more than 700 members. The commentary on the group’s wall was summed up by a Lyons Township High School student who said she did not know Iain but had learned an important lesson from his death.

“I’m learning to treat everyone with respect, even people who I don’t know well or people who I might not get along with,” she wrote. “If there is anything good that can come out of this tragedy, the responsibility lies with us to live with kindness and be aware that life is fragile.”

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10/14/2000 – New Suicide Warning in Great Britain

Here’s an email that Circare, a health rights organization, has
sent to the White House recently. Note the new warning that is
eliciting controversy in Great Britain:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Also attached are two relevant articles written by Sarah Boseley,
Health correspondent for the Guardian.

Mark

From: Vera Hassner Sharav, President
CIRCARE: Citizens for Responsible Care & Research,
A Human Rights Organization
Tel. 212-595-8974 FAX: 212-595-9086
veracare@…

In response to increasing public concern over suicides among
people taking Prozac and other SSRI anti-depressants, the
British Medicines Control Agency (MCA) (which is the equivalent
to the U.S. Food and Drug Administration) now requires the
manufacturers of Prozac and the other anti-depressants to add
the following warning to physicians and patients:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Why has the FDA failed to issue similar warnings to protect the
American public?

In the U.S. these drugs, though associated with an array of
severe adverse reactions in some patients, are widely and
haphazardly prescribed, not only for adults, but for children–even
toddlers and infants. Contrary to industry claims that these
drugs are safe– based on short-term (usually 6 week) clinical
trials before they were approved by the FDA– their long-term
effects have not been studied, nor is it known whether they are
safe for children.

According to FDA compiled data, in 1994 Prozac was prescribed
349,000 times in pediatric patients under 16 years; Zoloft was
prescribed 248,000 times. Furthermore, PROZAC was
prescribed 3,000 times for infants under one year old ! [See,
Psychiatric Times, March 1998, p. 69]

Instead of protecting the public by warning physicians and
patients about the risks associated with the drugs, the FDA is
protecting the profit-margins of drug manufacturers.

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40677
31,00.html

THE GUARDIAN

Prozac warning comes under fire
Position on suicidal tendencies is ‘dangerously misleading’

Sarah Boseley, health correspondent Guardian
Monday September 25, 2000

A new warning issued by the Medicines Control Agency, stating
that people may feel suicidal in the first few weeks of taking
Prozac and similar antidepressants, is dangerously misleading
and could lead to more deaths, according to a leading authority
on the drugs.

David Healy, director of the North Wales Department of
Psychological Medicine in Bangor, has told the MCA that among
those who are not severely depressed – who are the majority of
those now being given antidepressants – it is the drugs, and not
the illness, that make people want to kill themselves. The
warning will lead to doctors keeping their patients on the drugs
in the assumption that the medication will eventually make them
better, when they need to be taken off.
The new warning is the MCA’s response to increasing public
concern over suicides among people on drugs in the Prozac
class. The agency has instructed manufacturers to include it in
the drug datasheets for doctors and information leaflets for
patients. It states that suicidal thoughts may occur or increase in
the early weeks of treatment, and may continue for some time
until the drug takes effect.

But Dr Healy, the UK’s leading historian of antidepressant
medication, believes it is the drugs themselves that are causing
some people to feel like killing themselves – not depression. And
if, as the patient leaflet warning states, there is an increase in
suicidal thoughts, he says, it can only be due to an effect of the
drug. But increasingly the SSRIs (selective serotonin reuptake
inhibitors) are being given to adults and children who are not
depressed, but merely anxious and who should therefore have
no suicidal feelings.

Dr Healy has written to Keith Jones, director of the MCA, pointing
to two studies – one of them carried out by his own team –
showing that healthy volunteers with no history of depression
have become dangerously suicidal after taking one of the SSRI
class of drugs for a couple of weeks. “This will lead to deaths,”
he told Dr Jones in a letter. “Your advice will lead to a situation
where patients who worsen on treatment will be kept on that
treatment by their GPs in the belief that it is only in this way that
the suicide risk can ultimately be lowered. This is mistaken
advice that is going to increase the rate at which patients move
from emergent suicidality[beginning to feel suicidal] to suicidal
acts.”

Earlier this year, Dr Healy published a study of the effects of one
of the SSRIs, sertraline, on 20 healthy volunteers. Two of them
became suicidal.

One told researchers that she had become obsessed with the
idea of throwing herself under a car or a train, while the other
fantasized about hanging herself from a beam in the bedroom
ceiling.

The MCA also has in its possession a much earlier study of the
effects of sertraline on healthy volunteers. Dr Jones
acknowledged in a letter to Dr Healy that this study similarly
shows a “pattern of severe adverse side-effects and drop outs.”

He goes on to remark that the pattern “seen in this small study
was not replicated in any other study involving sertraline”. Yet it
has been – in the Healy study published earlier this year in
Primary Care Psychiatry and revealed in the Guardian in May.

These two studies, says Dr Healy, would be conclusive enough
for the manufacturers to get a license from the MCA to market
sertraline as a drug to cause agitation – if anybody had a use for
such a medicine. Yet the MCA will not accept that this, and other
SSRIs, can cause people to feel suicidal as a side-effect. The
MCA’s decision to require a new warning with the SSRIs was
taken after a review of the data by the Committee on the Safety of
Medicines.

The MCA said in a statement that the CSM had considered both
the healthy volunteer studies as part of the overall risk
assessment. “The CSM concluded that reports of suicidal
thoughts in healthy volunteers were difficult to explain, however,
other data were reassuring. For this reason, the issue will be
kept under review and further advice will be sought as
necessary.”

Guardian Unlimited © Guardian Newspapers Limited 2000

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40208
31,00.html

The GUARDIAN

Happy drug Prozac can bring on impulse to suicide, study says
As best-selling pill is prescribed by GPs for ever more sufferers
from mild depression, research brings disturbing evidence to
light

Sarah Boseley, health correspondent
Guardian

Monday May 22, 2000

Alarming evidence from a new British study shows that the
Prozac class of antidepressants can make healthy men, women
and children with no history of depression feel suicidal.

The research undermines the claims of Eli Lilly, makers of
Prozac, that people who kill themselves while on the tablets do
so because of their depression, and that the disease, not the
drug, is to blame for their suicide. Its findings are particularly
worrying because of the increasing numbers of people,
including children, who are being given the drugs by their GP for
mild depression, and who are not seriously clinically ill.

Prozac, the wonder pill of the 1980s and 1990s, became the
biggest drug company blockbuster of all time, prescribed to
more than 38m people around the world. It became a metaphor
for late 20th century life and a cult in its own right, enshrined in
a
book called Prozac Nation.

What began as a medicine for the clinically depressed has been
transformed by use and demand into a pill for minor ills. But
while the happy drug works for many people, in a significant
number it can take them to the edge of despair. The study,
conducted by David Healy, director of the North Wales
Department of Psychological Medicine, reveals the real dangers
for some of the SSRIs (selective serotonin reuptake inhibitors),
as Prozac and its imitators are called.

Nightmare

It found that two out of 20 healthy volunteers on an
antidepressant in the Prozac class called Lustral (or Zoloft in the
USA) became dangerously suicidal, compared with none of
them when they were put on an antidepressant of a different
class called reboxetine.

One 30-year-old woman who took part had a nightmare about
having her throat slit after one week and by the end of a fortnight,
was suicidal. “She felt hopeless and alone. It seemed that all
she could do was to follow a thought that had been planted in
her brain from some alien force. She suddenly decided she
should go and throw herself in front of a car, that this was the
only answer. “It was as if there was nothing out there apart from
the car, which she was going to throw herself under. She didn’t
think of her partner or child,” says the study, published in the
journal Primary Care Psychiatry. Later she completed a diary
entry, describing herself as jumpy, anxious and suspicious. “Her
mind was racing and spiraling out of control. Then it went blank
except for the clear thought that she must kill herself violently by
throwing herself beneath a car or a train.”

Dr Healy says the results of the research should be a warning to
GPs prescribing any SSRIs. “They may not all be equally the
same,” he told the Guardian. “But the risk holds for the whole of
the group.

Generally the findings would indicate that women and children
and those who are least ill may be most at risk.” All the drugs
have been licensed as both safe and efficacious on the basis of
data from clinical trials. But Dr Healy believes that there are
serious problems with the reporting of side-effects in these
trials, and that this has allowed drugs to be handed out to
millions around the globe without their true risks being
understood.

Volunteers taking part in the early trials were never asked
whether they experienced any suicidal feelings or the restless
agitation which can be the precursor of a suicide attempt. If
patients in later trials said they felt suicidal, it was recorded as
part of their depression.

Dr Healey has written to the Medicines Control Agency, which
licenses medicines in the UK, expressing his concern and
pointing out that he believes patients who today become suicidal
on SSRIs are in a state of “legal jeopardy”.

Firms are using data from trials that were not designed to look at
suicidality to prove that their drugs could not have caused it. Until
the system for reporting side-effects is changed, he questions
whether anybody should take part in clinical trials.

The new study’s findings have emerged at a time of acute
embarrassment for Eli Lilly. Its patent on Prozac (fluoxetine), is
soon to expire, but it recently bought the license for a second
version of the drug, called R-fluoxetine. The patent for the new
drug, it has just been revealed in the US, states that R-fluoxetine
is improvement on Prozac specifically as it is less likely to cause
“suicidal thoughts and self-mutilation”.

Eli Lilly argues that the patent was filed by the American scientist
Martin Teicher and the company Sepracor which devised the
new drug. Mr. Teicher, in 1990, was the first to warn that patients
on Prozac were becoming suicidal, but Eli Lilly has always
dismissed his study on the basis that those patients were
suffering chronic depression.

Dr Healy, the UK’s leading historian of antidepressant
medication who has given evidence against Lilly in litigation in
the US, has frequently taken issue with the major study
commissioned by the company to persuade the US Food and
Drugs Administration that Prozac carried no suicide risk. Dr
Healy has argued there has never been a prospective study and
that the retrospective 1991 Beasley study, as it is known,
included only a small selection of the trials that had taken place
on Prozac.

An internal memo released by Eli Lilly during recent litigation
appears to support Healy’s argument. In one of a series of
memos, dated August 27, 1990, a UK-based clinician tells Eli
Lilly management in Indianapolis that critics will be suspicious
of the fact that not all the trials were included and concludes that
it gives “the impression that the question of whether fluoxetine
provokes suicidal thoughts or not has not been properly
considered.”

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9/28/2000 – Learning from Fido’s accidental use of SSRIs

Thanks once again to Robin Eisner for another insightful article about SSRIs.

Warning: Be very careful of your pets around medications and read closely to
see what you might learn from the effects of SSRIs on Fido. This will leave
you asking why these drugs are intentionally given by vets to our pets.

Ann Blake-Tracy
____________

Accidental Antidepression
Dogs Hurt Inadvertently Swallowing Popular People Pills

More dogs these days are unintentionally chomping down their owners’
serotonin-enhancing antidepressants, such as Paxil and Prozac, than they were
five years ago. (Pat Wellenbach/AP Photo)

By Robin Eisner

N E W Y O R K, Sept. 28 Pooches across America are developing a dangerous
drug habit accidental consumption of their owners¹ Prozac-like drugs.
The National Animal Poison Control Center of the American Society for
the Prevention of Cruelty says more dogs these days are chomping down
unintentionally, that is their owners serotonin-enhancing antidepressants,
such as Paxil and Prozac, than they were five years ago.
Dogs are very dogged, explains Dr. Steve Hansen, director of the
Poison
Control Center, which is located in Champaign-Urbana, Ill. They will crush a
bottle of pills with their back molars and lap up the drugs or they will
quickly eat a tablet that an owner inadvertently dropped on the floor.

Established in 1978, the fee-for-service National Animal Poison Control
Center is the only 24-hour emergency telephone hotline staffed by 20
full-time veterinarians and five board-certified veterinary toxicologists in
North America.

Unintended Use

While veterinarians now prescribe antidepressants to dogs to treat canine
sadness, separation anxiety and other behavioral problems, the increasing
problem with unintended ingestion of these drugs by dogs is due, most likely,
to the rising popularity and use of this class of drugs by humans, Hansen
says.

In 1995, 50 percent of the antidepressants accident cases were of the
Prozac type, according to Jill Richardson, a veterinary poison information
specialist at the animal poison center. By 1999, that number jumped to 80
percent of 500 total antidepressant case calls.

The danger antidepressant drugs pose to Fido depends on the amount
wolfed down, the size of the dog and whether the dog had any pre-existing
medical conditions that might make it susceptible to an overdose, Hansen
says.

Danger Depends on Many Factors

Lethargy, vomiting and disorientation are among the symptoms a small dog,
such as a Chihuahua, could experience with a large dose of a Prozac-like
drug. The animal will walk around with its front legs not in sync with its
back legs, looking drunk, Hansen says.
Â
If the owner calls the poison control line before these symptoms develop,
the hotline veterinarians might recommend the owner induce regurgitation with
hydrogen peroxide easily found in most medicine cabinets. The dose with a 3
percent peroxide solution is one milliliter per pound of the dog, which
translates into 2 ounces for a 50-pound dog.

If the dog already is tipsy, however, the vets will probably ask the
owner to take the animal for emergency care, since the animal might need more
specialized treatment. The telephone vets also will suggest an older dog with
kidney disease get to a vet as soon as possible.

Homes Need to Be Pet-Proofed

To prevent an animal from accidental consumption of drugs, owners need to
dog- and cat-proof their house. Medications should be kept in a closed
cabinet beyond their reach, Hansen says. The No. 1 problem drug accidentally
consumed by pets are non-steroidal anti-inflammatory drugs, or medications
like acetaminophen, aspirin or ibuprofen.

While drugs can poison animals, pets also are susceptible to
insecticides, rodenticides and will drink spilled antifreeze and gasoline.
The antifreeze propylene glycol is less toxic to pets than ethylene glycol,
Hansen says.

Cat owners also should not use dog products containing the anti-flea
chemical permethrin on their felines. Owners should not assume because it is
OK for dogs, it is OK for cats, Hansen says. Cats may experience tremors
and seizures from the insecticide.

Why Vet Line Charges?

Pet owners must pay a $45 fee to get assistance from the vets at the
Animal Poison Control Center. The amount covers subsequent calls to the
hotline.

Unlike human poison control centers which are free because they receive
funding from federal, state and local government sources, the animal line
must charge because it only receives partial funding for its operation from
manufacturers of pet care products. The phone number is 1-888-426-4435.

Because large emergency veterinary centers are usually located in large
communities, a pet owner or a veterinarian in a rural community may only have
the hotline to get important toxicological information in a emergency
situation, according to Sharon Granskog, spokeswoman for the American
Veterinary Medical Association, in Schaumberg, Ill. They play a vital
service, she says.

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4/30/2000 – FDA Warns of Fatal Risks Linked to TriCitrasol

WASHINGTON, Apr 19 (Reuters Health) – The US Food and
Drug Administration (FDA) is warning US hospital pharmacies
and dialysis centers of at least one case of fatal cardiac arrest
linked to the unapproved injectable drug triCitrasol.

The agency issued its warning after learning of the fatality, in
which a patient went into cardiac arrest after receiving a 46.7%
concentration of the sodium citrate anticoagulant, which was
introduced into a hemodialysis permanent blood access
catheter. The catheter was implanted into the patient
immediately prior to the incident.

Rapid or excessive infusion of triCitrasol has been blamed for a
host of serious reactions, including fatal heart rhythm disorders,
seizures or bleeding due to loss of blood calcium.

The FDA is warning against the use of the drug with blood
access catheters. The agency said that it is currently reviewing a
number of additional cases that might be associated with
triCitrasol infusion when performing hemodialysis. The drug’s
manufacturer and its distributor are collaborating on the recall
effort.

Cytosol Laboratories, of Braintree, Massachusetts, markets the
drug in individual sterile, 30 mL glass vials and in catheter “kits.”
Medcomp, of Harleysville, Pennsylvania, distributes the kits
under the trade name Ash Split Catheter II, as well as the
individual vials. Medcomp is handling the recall of only those kits
and separate vials marketed before November 1, 1999.

“We have every single [catheter] kit tracked,” a Medcomp
spokeswoman told Reuters Health, noting that recall of the kits
began on April 9, followed by recall of the separate vials on April
14. The FDA claims that about 3,000 Cytosol catheter kits are
sold nationwide, although Todd Polk, Medcomp’s head of
regulatory affairs, would not confirm those numbers to Reuters
Health. Polk declined to speculate when the recall might be
brought to a close.

As to the question of whether Medcomp knew of the Cytosol
product’s status as an unapproved drug, Polk responded,
“obviously not.” The FDA said that alternative 4% citrate solutions
remain available for use in hospital pharmacies, hemodialysis
and other medical settings. The agency said that it is working
with Cytosol on a limited access plan, as the drug is still needed
in some cases to prepare white cells for transfusion.

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