[H] Infant Cold Medications Pulled From Drugstores
Posted: Fri Oct 12, 2007 2:06 pm
Infant Cold Medications Pulled From Drugstores
By Rob Stein
Washington Post Staff Writer
Friday, October 12, 2007; Page A01
Drugstores began clearing their shelves of over-the-counter cough and cold
medicine designed for infants yesterday after leading manufacturers
announced they were withdrawing the products amid rising concerns about the
safety of the popular remedies.
The decision to pull 14 products, including well-known brands such as
Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants'
Drops Plus Cold and Robitussin Infant Cough DM Drops, came one week before
the Food and Drug Administration plans to hold a hearing on nonprescription
cough and cold medications for children.
The hearing is part of a broad evaluation of the products the agency
launched in light of doubts about their effectiveness and mounting evidence
the medications can cause serious complications, including severe
hallucinations and agitation, seizures, high blood pressure, and heart and
breathing problems that can be fatal in rare cases.
The companies maintain that the products are safe and effective when used
properly but said they acted because of the risk of complications when
misused, with most complications apparently occurring in children younger
than 2.
"These medicines are -- and always have been -- safe at the recommended
doses," said Linda A. Suydam, president of the Consumer Healthcare Products
Association, the industry group that announced the withdrawal. "These
voluntary actions are being taken out of an abundance of caution."
The companies withdrawing the products -- McNeil Consumer Healthcare,
Novartis Consumer Health and Wyeth -- represent at least 95 percent of the
market, the association said.
Critics of the products welcomed the move but called for the FDA to take
further action, saying the products pose a hazard even when used at the
proper doses.
"Today's action is an important step in the right direction, but FDA must do
more to protect children," said Joshua M. Sharfstein, Baltimore's health
commissioner, who led a petition to the FDA after four children died in
Baltimore after taking the medications. "Clearly, the products don't work
and are unsafe."
Sharfstein said the FDA should institute a formal ban on the products for
children age 2 and younger to make sure no other companies begin offering
them. "You don't want another manufacturer coming along and saying, 'Hey,
this looks like a good market for me,' " he said. In addition, Sharfstein
said the agency should strengthen warning labels on the dozens of products
still on the market that advise against their use in children younger than
6, and bar packaging that includes terms such as "toddler" that might
encourage parents to use the medications in children that young.
"There is no evidence that the products are effective for young children,
and there is evidence they can be unsafe, even at the usual doses. This is
not just about misuse," he said, noting that the dosages typically used are
untested estimates based on studies in adults. "That's why we are asking FDA
to clearly label these products against use by children under age 6." ...
Industry representatives defended plans to continue marketing products
designed for children older than 2, saying they offer parents useful
medications.
"We think they can be used safely," Suydam said. "When we looked at these
cases, we found the biggest problem was accidental ingestion. We think that
can be addressed with an education program about storing these products
safely."
The organization did, however, favor adding new label warnings advising
parents against using antihistamines to help their children sleep, which can
be dangerous.
"This is a practice that has become more common, and we want to put a stop
to it," Suydam said.
Over-the-counter cough and cold medications have long been a mainstay for
parents trying to comfort children fighting common colds, coughs and other
upper respiratory infections. Although many leading medical groups,
including the American Academy of Pediatrics, have long questioned their
effectiveness and recommended against their use, they remain popular,
especially for parents desperate to help a sick child.
Critics have long argued that there is virtually no good evidence that they
work as drugmakers claim and good evidence that they can be dangerous.
"Given that there are serious consequences, including death, associated with
the use of these products without compelling reason to use them, why are
they being marketed for children?" Sharfstein asked. "The contrast between
the state of the evidence and the displays in drugstores could not be more
stark."
Sharfstein noted that some of the medications have been sold in packages
that depict babies and toddlers and include droppers designed to administer
doses supposedly safe for infants. The Prescription Project, a private
nonprofit research group in Boston, estimated that companies spend at least
$50 million a year marketing these products.
No one knows how many children have had adverse reactions to
over-the-counter cough and cold medications, but the federal Centers for
Disease Control and Prevention reported earlier this year that an
investigation it launched found that at least 1,500 children younger than 2
suffered complications in 2004 and 2005. An FDA review prepared for next
week's meeting describes dozens of cases of convulsions, heart problems,
trouble breathing, neurological complications and other reactions, including
at least 54 deaths involving decongestants and 69 deaths involving
antihistamines.
Many doctors say they advise their patients against using the products and
instead suggest they try Tylenol to alleviate pain, use humidifiers and
saltwater solutions to alleviate congestion, and give plenty of fluids to
keep the child hydrated. But distressed parents can be persuaded by heavy
marketing, some say.
"When your kid is sick, you get a little desperate and think you have to do
something," said Daniel J. Levy, a pediatrician in Owings Mills, Md.
Sales of nonprescription cough and cold remedies marketed toward children
rose 20 percent, to $311.3 million, in the year that ended Sept. 8
(excluding sales at Wal-Mart stores), according to ACNielsen, a New
York-based market research company. About 15 percent of U.S. households
bought these products in the year ended June 30, ACNielsen said.
Several major drugstore chains said they immediately began pulling the
products from their shelves and blocking sales of the medications at their
registers, along with any store-brand equivalents.
By Rob Stein
Washington Post Staff Writer
Friday, October 12, 2007; Page A01
Drugstores began clearing their shelves of over-the-counter cough and cold
medicine designed for infants yesterday after leading manufacturers
announced they were withdrawing the products amid rising concerns about the
safety of the popular remedies.
The decision to pull 14 products, including well-known brands such as
Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants'
Drops Plus Cold and Robitussin Infant Cough DM Drops, came one week before
the Food and Drug Administration plans to hold a hearing on nonprescription
cough and cold medications for children.
The hearing is part of a broad evaluation of the products the agency
launched in light of doubts about their effectiveness and mounting evidence
the medications can cause serious complications, including severe
hallucinations and agitation, seizures, high blood pressure, and heart and
breathing problems that can be fatal in rare cases.
The companies maintain that the products are safe and effective when used
properly but said they acted because of the risk of complications when
misused, with most complications apparently occurring in children younger
than 2.
"These medicines are -- and always have been -- safe at the recommended
doses," said Linda A. Suydam, president of the Consumer Healthcare Products
Association, the industry group that announced the withdrawal. "These
voluntary actions are being taken out of an abundance of caution."
The companies withdrawing the products -- McNeil Consumer Healthcare,
Novartis Consumer Health and Wyeth -- represent at least 95 percent of the
market, the association said.
Critics of the products welcomed the move but called for the FDA to take
further action, saying the products pose a hazard even when used at the
proper doses.
"Today's action is an important step in the right direction, but FDA must do
more to protect children," said Joshua M. Sharfstein, Baltimore's health
commissioner, who led a petition to the FDA after four children died in
Baltimore after taking the medications. "Clearly, the products don't work
and are unsafe."
Sharfstein said the FDA should institute a formal ban on the products for
children age 2 and younger to make sure no other companies begin offering
them. "You don't want another manufacturer coming along and saying, 'Hey,
this looks like a good market for me,' " he said. In addition, Sharfstein
said the agency should strengthen warning labels on the dozens of products
still on the market that advise against their use in children younger than
6, and bar packaging that includes terms such as "toddler" that might
encourage parents to use the medications in children that young.
"There is no evidence that the products are effective for young children,
and there is evidence they can be unsafe, even at the usual doses. This is
not just about misuse," he said, noting that the dosages typically used are
untested estimates based on studies in adults. "That's why we are asking FDA
to clearly label these products against use by children under age 6." ...
Industry representatives defended plans to continue marketing products
designed for children older than 2, saying they offer parents useful
medications.
"We think they can be used safely," Suydam said. "When we looked at these
cases, we found the biggest problem was accidental ingestion. We think that
can be addressed with an education program about storing these products
safely."
The organization did, however, favor adding new label warnings advising
parents against using antihistamines to help their children sleep, which can
be dangerous.
"This is a practice that has become more common, and we want to put a stop
to it," Suydam said.
Over-the-counter cough and cold medications have long been a mainstay for
parents trying to comfort children fighting common colds, coughs and other
upper respiratory infections. Although many leading medical groups,
including the American Academy of Pediatrics, have long questioned their
effectiveness and recommended against their use, they remain popular,
especially for parents desperate to help a sick child.
Critics have long argued that there is virtually no good evidence that they
work as drugmakers claim and good evidence that they can be dangerous.
"Given that there are serious consequences, including death, associated with
the use of these products without compelling reason to use them, why are
they being marketed for children?" Sharfstein asked. "The contrast between
the state of the evidence and the displays in drugstores could not be more
stark."
Sharfstein noted that some of the medications have been sold in packages
that depict babies and toddlers and include droppers designed to administer
doses supposedly safe for infants. The Prescription Project, a private
nonprofit research group in Boston, estimated that companies spend at least
$50 million a year marketing these products.
No one knows how many children have had adverse reactions to
over-the-counter cough and cold medications, but the federal Centers for
Disease Control and Prevention reported earlier this year that an
investigation it launched found that at least 1,500 children younger than 2
suffered complications in 2004 and 2005. An FDA review prepared for next
week's meeting describes dozens of cases of convulsions, heart problems,
trouble breathing, neurological complications and other reactions, including
at least 54 deaths involving decongestants and 69 deaths involving
antihistamines.
Many doctors say they advise their patients against using the products and
instead suggest they try Tylenol to alleviate pain, use humidifiers and
saltwater solutions to alleviate congestion, and give plenty of fluids to
keep the child hydrated. But distressed parents can be persuaded by heavy
marketing, some say.
"When your kid is sick, you get a little desperate and think you have to do
something," said Daniel J. Levy, a pediatrician in Owings Mills, Md.
Sales of nonprescription cough and cold remedies marketed toward children
rose 20 percent, to $311.3 million, in the year that ended Sept. 8
(excluding sales at Wal-Mart stores), according to ACNielsen, a New
York-based market research company. About 15 percent of U.S. households
bought these products in the year ended June 30, ACNielsen said.
Several major drugstore chains said they immediately began pulling the
products from their shelves and blocking sales of the medications at their
registers, along with any store-brand equivalents.