Warning about Children's Advil ~ Motrin ~ Ibuprofen
x-posted
Lawsuits put focus on Ibuprofen for children
Full story:
http://archives.seattletimes.nwsource.com/cgi-bin/texis/web/vortex/display?s
lug=ibuprofen04&date=20050104
By Linda Goldston
Knight Ridder Newspapers
SAN JOSE, Calif. -- Nine-year-old Kaitlyn Langstaff of Saratoga,
Calif., died 20 months after taking Children's Motrin. Seven-year-old
Sabrina Brierton Johnson of Los Angeles went blind two months after taking
the same drug. Three-year-old Heather Rose Kiss of New Jersey died a week
after taking a few doses of Children's Advil.
All three girls developed a rare, excruciatingly painful disease after an
apparent allergic reaction to ibuprofen. And the parents of all three said
they never dreamed an over-the-counter pain reliever could kill or disable
their children.
The U.S. Food and Drug Administration has not required the makers of
ibuprofen to include the life-threatening disease or its symptoms on
nonprescription labels for children and adults medicines. But warnings are
required on prescription-strength ibuprofen and other prescription drugs
that can cause the same rash as the disease.
The FDA and a spokesman for the maker of Children's Advil said no warning
is needed because the disease is so rare.
There are an estimated one to six cases of Stevens Johnson Syndrome per
million people in the United States each year, some caused by drug
reactions.
Stevens Johnson syndrome (SJS) and its various forms can afflict people of
all ages. But the Stevens Johnson Syndrome Foundation has seen a jump in
reports of cases involving children and ibuprofen in the past year.
"We're getting about one or two reports of new cases each month," said Jean
McCawley, director and founder of the Westminster, Colo.-based foundation.
"The only thing that's rare about SJS is that it's not mandatory to report
it to the FDA."
After the third lawsuit in two years was filed last week against the makers
of Children's Motrin -- health-care giant Johnson &a Johnson and its
subsidiary McNeil Consumer & Specialty Pharmaceuticals -- a
spokeswoman said McNeil will look into the case.
"As the makers of Children's Motrin products, we are deeply concerned by
all matters relating to our products and we are investigating the
situation," said Bonnie Jacobs of Fort Washington, Pa.-based McNeil.
Fran Sullivan, spokesman for Wyeth Consumer Health Care, the maker of
Children's Advil, said he had no personal knowledge of Heather Rose Kiss'
death, but added: "If it turns out this child died after taking Children's
Advil, we would look into it as well. We want to get the information so we
can investigate it."
In the suit filed last Tuesday, Sabrina Brierton Johnson and her parents
allege that Motrin's makers knew the product could cause the rare and
sometimes deadly allergic reactions called Stevens Johnson Syndrome and
toxic epidermal necrolysis -- and that they failed to warn consumers.
The family is seeking monetary damages, but also wants the drug maker to
take Children's Motrin off the market until it carries a warning about the
syndrome and its symptoms.
They said parents and doctors need to know that they should stop giving
children ibuprofen at the first sign of a rash to prevent the disease from
advancing to the more serious toxic epidermal necrolysis, which kills about
a third of its victims. Symptoms also include blisters on the ears, nose and
genital area and sores on the inside of the mouth.
Kaitlyn's parents received a confidential settlement in a similar suit in
November and said they can't discuss the case. McNeil also settled in
November with the parents of a young Texas girl.
Before the settlement, Kerry Langstaff, Kaitlyn's mother, said the family
hoped to educate the medical community and parents about the
over-the-counter drug causing this disease.
"We can't tell you how many doctors and nurses have said to us, 'I didn't
know,' " Langstaff said.
Not M&Ms
After a 20-month struggle to overcome the disease, which left her unable to
see, speak, breathe on her own or eat without a tube in her stomach, Kaitlyn
died just before Christmas a year ago.
Dr. Roy Levin, who said he was unaware of the association between
Children's Motrin and Stevens Johnson Syndrome until he treated Kaitlyn,
said of the drug companies: "They have to warn people who think it's as safe
as getting M&Ms."
And Darlene Kiss, Heather Rose's mother, said she believes parents have the
right to know that medicines used routinely for children have the potential
for such catastrophic consequences.
"Even if it's a verbal warning from the doctor, it would make you think,"
Kiss said. Heather Rose Kiss died March 17, 2003. Her mother has hired an
attorney but has not filed suit.
A number of other drugs can cause Stevens Johnson Syndrome, and some of
them carry warnings about the risk of severe skin reactions. Although the
FDA has acknowledged that ibuprofen can cause the syndrome, it has not
ordered pharmaceutical companies to mention the disease on over-the-counter
ibuprofen labels, saying the risk of harm is too low.
Space on drug labels should be devoted to more common adverse reactions,
such as gastrointestinal bleeding and kidney problems, it says.
"There is only so much you can put on a label," the FDA said in a
statement. "We already know that the longer the labels, the less someone is
going to read them."
The FDA said it has received about 150 reports of the syndrome in patients
who had used ibuprofen over the years. The agency would not say how common a
side effect needs to be to trigger a specific warning on the label.
However, Pfizer announced last month that it will add a "black-box" warning -- the strongest a drug can carry -- to the label of its
prescription painkiller Bextra after 87 people taking the drug developed
severe skin reactions, including Stevens Johnson Syndrome and toxic
epidermal necrolysis, and four died. Bextra and ibuprofen are part of the
same broad class of drugs, known as nonsteroidal anti-inflammatory drugs, or
NSAIDs.
Medical problems
These days Sabrina is back at home, but her eyes are so sensitive to
light that she must wear a hat pulled down over her face all the time, and
she has numerous other medical problems from the disease.
"Johnson & Johnson's failure to warn has cost Sabrina her sight and has
cost other innocent children their lives," her mother said. "It's time for
the truth to be told, and it's time for Johnson & Johnson to do the
responsible thing and put proper warnings and instructions on Children's
Motrin."
Lawsuits put focus on Ibuprofen for children
Full story:
http://archives.seattletimes.nwsource.com/cgi-bin/texis/web/vortex/display?s
lug=ibuprofen04&date=20050104
By Linda Goldston
Knight Ridder Newspapers
SAN JOSE, Calif. -- Nine-year-old Kaitlyn Langstaff of Saratoga,
Calif., died 20 months after taking Children's Motrin. Seven-year-old
Sabrina Brierton Johnson of Los Angeles went blind two months after taking
the same drug. Three-year-old Heather Rose Kiss of New Jersey died a week
after taking a few doses of Children's Advil.
All three girls developed a rare, excruciatingly painful disease after an
apparent allergic reaction to ibuprofen. And the parents of all three said
they never dreamed an over-the-counter pain reliever could kill or disable
their children.
The U.S. Food and Drug Administration has not required the makers of
ibuprofen to include the life-threatening disease or its symptoms on
nonprescription labels for children and adults medicines. But warnings are
required on prescription-strength ibuprofen and other prescription drugs
that can cause the same rash as the disease.
The FDA and a spokesman for the maker of Children's Advil said no warning
is needed because the disease is so rare.
There are an estimated one to six cases of Stevens Johnson Syndrome per
million people in the United States each year, some caused by drug
reactions.
Stevens Johnson syndrome (SJS) and its various forms can afflict people of
all ages. But the Stevens Johnson Syndrome Foundation has seen a jump in
reports of cases involving children and ibuprofen in the past year.
"We're getting about one or two reports of new cases each month," said Jean
McCawley, director and founder of the Westminster, Colo.-based foundation.
"The only thing that's rare about SJS is that it's not mandatory to report
it to the FDA."
After the third lawsuit in two years was filed last week against the makers
of Children's Motrin -- health-care giant Johnson &a Johnson and its
subsidiary McNeil Consumer & Specialty Pharmaceuticals -- a
spokeswoman said McNeil will look into the case.
"As the makers of Children's Motrin products, we are deeply concerned by
all matters relating to our products and we are investigating the
situation," said Bonnie Jacobs of Fort Washington, Pa.-based McNeil.
Fran Sullivan, spokesman for Wyeth Consumer Health Care, the maker of
Children's Advil, said he had no personal knowledge of Heather Rose Kiss'
death, but added: "If it turns out this child died after taking Children's
Advil, we would look into it as well. We want to get the information so we
can investigate it."
In the suit filed last Tuesday, Sabrina Brierton Johnson and her parents
allege that Motrin's makers knew the product could cause the rare and
sometimes deadly allergic reactions called Stevens Johnson Syndrome and
toxic epidermal necrolysis -- and that they failed to warn consumers.
The family is seeking monetary damages, but also wants the drug maker to
take Children's Motrin off the market until it carries a warning about the
syndrome and its symptoms.
They said parents and doctors need to know that they should stop giving
children ibuprofen at the first sign of a rash to prevent the disease from
advancing to the more serious toxic epidermal necrolysis, which kills about
a third of its victims. Symptoms also include blisters on the ears, nose and
genital area and sores on the inside of the mouth.
Kaitlyn's parents received a confidential settlement in a similar suit in
November and said they can't discuss the case. McNeil also settled in
November with the parents of a young Texas girl.
Before the settlement, Kerry Langstaff, Kaitlyn's mother, said the family
hoped to educate the medical community and parents about the
over-the-counter drug causing this disease.
"We can't tell you how many doctors and nurses have said to us, 'I didn't
know,' " Langstaff said.
Not M&Ms
After a 20-month struggle to overcome the disease, which left her unable to
see, speak, breathe on her own or eat without a tube in her stomach, Kaitlyn
died just before Christmas a year ago.
Dr. Roy Levin, who said he was unaware of the association between
Children's Motrin and Stevens Johnson Syndrome until he treated Kaitlyn,
said of the drug companies: "They have to warn people who think it's as safe
as getting M&Ms."
And Darlene Kiss, Heather Rose's mother, said she believes parents have the
right to know that medicines used routinely for children have the potential
for such catastrophic consequences.
"Even if it's a verbal warning from the doctor, it would make you think,"
Kiss said. Heather Rose Kiss died March 17, 2003. Her mother has hired an
attorney but has not filed suit.
A number of other drugs can cause Stevens Johnson Syndrome, and some of
them carry warnings about the risk of severe skin reactions. Although the
FDA has acknowledged that ibuprofen can cause the syndrome, it has not
ordered pharmaceutical companies to mention the disease on over-the-counter
ibuprofen labels, saying the risk of harm is too low.
Space on drug labels should be devoted to more common adverse reactions,
such as gastrointestinal bleeding and kidney problems, it says.
"There is only so much you can put on a label," the FDA said in a
statement. "We already know that the longer the labels, the less someone is
going to read them."
The FDA said it has received about 150 reports of the syndrome in patients
who had used ibuprofen over the years. The agency would not say how common a
side effect needs to be to trigger a specific warning on the label.
However, Pfizer announced last month that it will add a "black-box" warning -- the strongest a drug can carry -- to the label of its
prescription painkiller Bextra after 87 people taking the drug developed
severe skin reactions, including Stevens Johnson Syndrome and toxic
epidermal necrolysis, and four died. Bextra and ibuprofen are part of the
same broad class of drugs, known as nonsteroidal anti-inflammatory drugs, or
NSAIDs.
Medical problems
These days Sabrina is back at home, but her eyes are so sensitive to
light that she must wear a hat pulled down over her face all the time, and
she has numerous other medical problems from the disease.
"Johnson & Johnson's failure to warn has cost Sabrina her sight and has
cost other innocent children their lives," her mother said. "It's time for
the truth to be told, and it's time for Johnson & Johnson to do the
responsible thing and put proper warnings and instructions on Children's
Motrin."