[e-drug] Cough and cold remedies under the spotlight in USA

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Cough and cold drugs under the spotlight in USA
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[Thanks to Dr Gopal Dabade for spotting; copied as fair use. WB]

http://www.reuters.com/article/domesticNews/idUSN1833809520071019?sp=true
 
U.S. panel against cold drugs for kids under 6
Fri Oct 19, 2007 7:38pm EDT
By Lisa Richwine

SILVER SPRING, Maryland (Reuters) - Over-the-counter cough and cold medicines that have been widely used for decades should not be given to children under 6 years of age, a U.S. advisory panel recommended on Friday.
The panel said manufacturers need to conduct clinical trials to show the medicines actually work for children.
Members said evidence from studies was lacking and it was inappropriate to keep relying on adult data to suggest the medicines benefit kids.
"The studies that are available do not demonstrate efficacy," said panel member Dr. Robert Daum, a pediatric infectious diseases expert at the University of Chicago Children's Hospital.
The U.S. Food and Drug Administration will consider the advice as it weighs complaints from pediatricians that the medicines do not work and can be dangerous for young children.
A group of pediatricians and public health officials have petitioned the FDA to restrict sales for children younger than 6 years old. They are alarmed by reports of deaths, seizures, hallucinations and other problems in some children who took the medicines. 
Makers said the products are safe and effective, when given as directed, to children aged 2 and older. Last week, major manufacturers voluntarily pulled 14 cough and cold products for children up to age 2.
The FDA advisory committee, after two days of testimony and deliberations, voted 21-1 that use for kids under 2 should not be recommended for over-the-counter cough and cold products that contain antihistamines, decongestants or antitussives. 
The panel voted 13-9 against using the products for children aged 2 and 6. However, in a 15-7 vote, the panel declined to recommend against the medicines for ages 6 to 12. 
Although the drugs have been sold for decades, the FDA generally has not required companies to prove they work for children. Instead, data was extrapolated from adults.
The products include versions of Wyeth's Dimetapp and Johnson & Johnson's Tylenol and PediaCare. About 95 million packages are sold in the United States each year, according to the Consumer Healthcare Products Association (CHPA), which represents nonprescription drugmakers. 
The panel felt reports of serious harm were "very rare" and in many cases related to overdose or misuse, said John Jenkins, director of the FDA's Office of New Drugs.
The panel recommendations may not translate into any immediate changes in how the drugs are marketed. A formal process for amending current rules could take years, but companies may be able to take voluntary actions.
"We need to take back and discuss internally within the agency all the advice we've heard," Jenkins said.
The agency could issue a public statement about its views on safe and effective use of the products, he said.
Current advice for parents is to follow instructions on product labels and make sure they are not giving children multiple products with the same ingredient, he said. The FDA has never approved language recommending the medicines for kids under age 2, he added. 
CHPA President Linda Suydam said nonprescription drugmakers would work with the FDA to develop appropriate studies of effectiveness and she believed the products would remain on the market.
"Under the law, they are still considered safe and effective," Suydam told reporters.
Johnson & Johnson unit McNeil Consumer Healthcare said it would work with the FDA "to obtain the information necessary to provide parents and doctors with appropriate treatment choices for children."

2) http://www.reuters.com/article/topNews/idUSN1833809520071018?sp=true
Doctors warn of harm from kids' cough, cold drugs
Thu Oct 18, 2007 4:37pm EDT
By Lisa Richwine

SILVER SPRING, Maryland (Reuters) - U.S. health advisers considered on Thursday if over-the-counter cough and cold medicines should still be sold for young children, as pediatricians argued the drugs are dangerous and do not work. 
Manufacturers said the medicines used by millions of parents were safe and effective for kids when given as directed.
A committee of experts that advise the Food and Drug Administration is expected to make recommendations on Friday.
A week ago, Johnson & Johnson, Wyeth and other major manufacturers voluntarily pulled cough and cold drugs for children up to age 2. But physicians are pushing the government to restrict marketing for use up to age 6. 
"Cough and cold products pose genuine risks when given to children under the age of 6 with no associated benefit," Dr. Michael Shannon, professor of pediatrics at Harvard Medical School, told the FDA panel.
Experts have grown alarmed by reports of deaths, seizures, hallucinations and other problems in some children who took the widely sold medicines.
Although the medicines have been widely sold for years, the FDA generally has not required companies to prove they work in children. Instead, data was extrapolated from adults.
While most evidence comes from adult use, "there are pediatric studies that demonstrate efficacy in children under 12, even as young as six months of age. The FDA has recognized these medicines as effective for years," said Linda Suydam, a former FDA official. 
She now is president of the Consumer Healthcare Products Association, a trade group for over-the-counter drugmakers.
Problems were rare and typically followed an accidental overdose, the makers said. A parent, for example, may have mistakenly given too much, or a curious toddler might have swallowed a high dose. Caregivers also may have unknowingly given more than one product with the same ingredients. 
The industry group said it was planning a campaign to educate parents about proper use.
The FDA is asking the advisory panel if the medicines are appropriate for various age groups up to age 12 and if regulatory action is needed. The meeting follows a petition from Shannon and others concerned about the drugs. 
The agency said it received 54 reports of deaths with decongestants and 69 with antihistamines from 1969 through 2006, FDA staff said. Most were in children younger than 2.
Companies have widely advertised the products under names including PediaCare and Little Colds with pictures of smiling babies and other images. About 95 million packages are sold in the United States each year, an industry group said. 
FDA medical officer Lolita Lopez said 11 clinical trials testing the medicines in children had been published in the past 50 years. The studies did not show the medicines were effective, she said, but added the research had limitations. 
The products contain a variety of ingredients that include decongestants, expectorants, antihistamines, cough suppressants and analgesics.
Dr. Daniel Levy, president of the Maryland chapter of the American Academy of Pediatrics, criticized widespread marketing with messages meant to reassure concerned parents.
"The products are advertised in all kinds of media to vulnerable people who worry about their children," Levy told the panel.


3) http://www.reuters.com/article/domesticNews/idUSN2819639920070929?sp=true
FDA staff urge warnings on kids' cold medicines
Fri Sep 28, 2007 9:15pm EDT
WASHINGTON (Reuters) - Over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not recommended for very young children, U.S. Food and Drug Administration reviewers have recommended. 
The FDA has not made a final decision on whether to change the warnings or instructions for use on the widely used drugs, officials said in documents released late on Thursday. The agency will seek input from a panel of outside advisers next month. 
Officials said in March they were reviewing use of over-the-counter cough and cold medicines in children. A group of doctors and public health officials had filed a petition voicing concerns that the drugs were risky and not effective for children. 
FDA reviewers said reports submitted to the agency "suggest that the use of prescription and (over-the-counter) cough and cold medication in younger children, particularly in children less than 2 years of age, could result in fatal overdoses." 
The product labels "should include prominent language to describe the risk of overdose in children," the FDA staff said in a summary posted on the agency's Web site.
They also recommended dropping the statement on many over-the-counter cough and cold remedies urging parents to "consult a physician" about use of decongestants in children under 2 years of age and antihistamines in children under 6 years of age. 
"We suggest that the revised wording state that dosing is not recommended in these age groups due to the lack of evidence of efficacy and safety concerns," the FDA staff said.
The agency received 54 reports of deaths with decongestants and 69 with antihistamines from 1969 through 2006, reviewers said. Most were in children younger than 2. Overdose and "drug toxicity" were commonly reported in those cases. 
More than 800 cough and cold products are sold in the United States with ingredients that include decongestants, expectorants, antihistamines, cough suppressants, analgesics and fever reducers.
Makers include Wyeth, Johnson & Johnson and Procter & Gamble Co. Officials at the three companies could not immediately be reached for comment.
The Consumer Healthcare Products Association, which represents makers of over-the-counter drugs, said its analysis "supports the safety of these important medicines when used in recommended doses. It also, however, illuminates rare cases of overdose." 
The group said it supported changing the labels for all over-the-counter cough and cold medicines to read "Do Not Use" in children under age 2.
(Reporting by Lisa Richwine)
 
4)  http://www.reuters.com/article/domesticNews/idUSWNAS604120071011?sp=true
Johnson & Johnson recalls infant cold medicines
Thu Oct 11, 2007 10:01am EDT

CHICAGO (Reuters) - Johnson & Johnson is recalling certain infants' nonprescription cough and cold products because of the danger of overdose, the company said on Thursday.

Data show that when misused, the medicines can lead to overdose, especially in infants under 2 years old, the company said.

It is recalling Concentrated Infants' TYLENOL Drops Plus Cold; Concentrated Infants' TYLENOL Drops Plus Cold & Cough; PEDIACARE Infant Drops Decongestant (PSE); PEDIACARE Infant Drops Decongestant & Cough (PSE); PEDIACARE Infant Dropper Decongestant (PE); PEDIACARE Infant Dropper Long-Acting Cough; and PEDIACARE Infant Dropper Decongestant & Cough (PE) products from the U.S. market.

The drugs are made by J&J's McNeil Consumer Healthcare unit, which also makes Tylenol, Benadryl, Rolaids antacid, St. Joseph aspirin, Sudafed nasal decongestants.and Motrin.

Cough and cold products for children aged 2 and over, and single-ingredient pain reliever/fever reducers expressly labeled for infants, are not included in the recall.

Questions have been raised for more than a year about the safety of the use of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.

Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.

The issue is still under review at the FDA.

Many experts say there is little evidence that these medicines are effective in such young children and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.

Questions about the products should be directed to McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish).

(Reporting by Debra Sherman)
 
5)  Two videos on the cough and cold remedies in US

1 - Are child meds safe & effective?
http://www.reuters.com/news/video/videoStory?videoId=69100

2 - Recall for children's cold meds
http://www.reuters.com/news/video/videoStory?videoId=68632