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May 02, 2008

Six baby cough medicines taken off UK shelves

Six Baby Cough Medicines Taken off UK Shelves

LONDON (Reuters) Mar 27 - Six cough medicines for children under 2 years old were taken off pharmacy shelves on Thursday over fears of possible accidental overdose.
The government's medicines regulator said it had ordered the action after increasing reports of adverse reactions by small children to drugs in the preparations, including five deaths since 1981.
Parents will be advised instead to use paracetamol or ibuprofen to lower temperatures in young children with a cold or cough, and to give them a simple cough syrup containing glycerol, honey or lemon.
A spokeswoman for the Medicines and Healthcare products Regulatory Agency said the products were not dangerous and would return to open sale once manufacturers had altered packaging making clear they were not suitable for children under two.
"If it was a dangerous drug we would have it off the market in seconds," she said. "It's not dangerous, it's what people are doing with it."
"We have seen an increase in adverse reactions over the last 20 years starting to build up a head of steam," she added.
The following six products directly targeted at children less than two years were ordered to be removed from shelves:
-- Asda Children's Chesty Cough Syrup
-- Boots Chesty Cough Syrup 1 Year Plus
-- Boots Sore Throat and Cough Linctus 1 Year Plus
-- Buttercup Infant Cough Syrup
-- CalCough Chesty
-- Bell's Children's Chesty Cough

The medicines can still be sold under advice by pharmacists to parents for older children.
"Children under two are more vulnerable due to their small size and therefore may be particularly susceptible to the effects of overdose," the MHRA said. "This new advice will reduce that possibility and is a precautionary measure."
Medicines trade body the Proprietary Association of Great Britain stressed that the treatments had not been banned and were safe to use as directed.
"Companies are taking this action voluntarily because the wellbeing of babies and young children is paramount," said the association's executive director Sheila Kelly.
"Parents should not be concerned that they have harmed their children in any way if they have given them cold remedies in the past. They are safe when used as recommended and can still be used for children over two."

FDA Warns of Cough, Cold Medicine Risk to Children
Warning doesn't go far enough, Public Citizen charges

By Mark HuffmanConsumerAffairs.Com
January 18, 2008
This just in – the U.S. Food and Drug Administration has issued an advisory on cough and cold products for children, three months after the drug manufacturers themselves warned the products might be harmful to children under age two.
In a Public Health Advisory for parents and caregivers, the agency recommends that over-the-counter cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur.
Most U.S. pharmacies began to remove those products after the drug company's warning, issued on October 12, 2007. However, the recall was voluntary and not all of the products were immediately removed.
The consumer organization Public Citizen said the FDA's warning is not only late but inadequate.
"By simply warning parents not to administer over-the-counter cough and cold remedies to children under the age of two, the FDA has failed to properly address the glaring risks presented by this category of drugs," Public Citizen said.
In fact, the group said, there is no evidence that these products are safe and effective for children over the age of two the group said. The agency didn’t even follow the recommendation of its own advisory committee, which voted on Oct. 19 to limit these products to children over the age of 6, Public Citizen charged.
Drugmakers have long claimed that pediatric cough and cold preparations, made popular through heavy marketing of a dizzying variety of combination products in child-friendly flavors, provide relief for cough and cold symptoms but Public Citizen said the products have never been proven to be effective.
Ineffective, unsafe
“The advisory committee declared the products were ineffective in younger children, but we were not able to identify a single adequately designed study that compared the efficacy of these products in older and younger children,” Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Thus the product’s efficacy remains unproven in all children under the age of 12.
“The companies have known for decades that their products are unproven, yet they have continued to foist them on concerned parents who believe that the FDA protects them and their children from ineffective medications,” said Lurie.
“Simply because these drugs are well-tolerated by many children is not an adequate rationale for allowing them on the market. The law is clear that ineffective medications are not to be sold, no matter how safe they appear to be,” he said.
Adverse effects
This week's FDA advisory stated that there are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.
"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."
The announcement does not include the FDA's "final" recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing, according to the FDA. The agency said it would issue its recommendations on use of the products in children ages 2 to 11 years as soon as the review is complete.
The FDA said that pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should: • Follow the dosing directions on the label of any OTC medication, • Understand that these drugs will NOT cure or shorten the duration of the common cold, • Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and • Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.
The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.
October recall
In October, Wyeth Pharmaceutical recalled some children’s cough medicine because the bottle caps, used to measure dosage, don’t accurately mark the half-teaspoon level recommended for children ages 2 to 5.
The recall affected several Robitussin products and Children’s Dimetapp Cold & Chest Congestion.
While the company said there was nothing wrong with the medicine, dosage can be critically important when administered to young children. Public health officials, including the City of Baltimore Health Department, recently asked the Food and Drug Administration to ban cough medicines for kids because overdosing can cause serious injury and even death.
A taste of honey
A natural solution to the problem may be at hand.
A study published in December found that a single dose of buckwheat honey before bedtime provided the greatest relief from cough and sleep difficulty compared with no treatment and an over-the-counter cough medicine in children with upper respiratory tract infections.
The study was published in the December issue of Archives of Pediatrics & Adolescent Medicine.

US Pharmacist:
Medical professionals advise against administering oral pseudoephedrine to young children and infants due to reports of a 3 year old child hallucinating after receiving the 20 mg doses of pseudoephedrine. The child was taken to the hospital after repeated hallucinations

MMR Weekly January 12, 2007 / 56(01);1-4
Infant Deaths Associated with Cough and Cold Medications --- Two States, 2005

Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants commonly are used alone or in combination in attempts to temporarily relieve symptoms of upper respiratory tract infection in children aged <2>

The three infants ranged in age from 1 to 6 months; two were male. All three infants had what appeared to be high levels of pseudoephedrine (a nasal decongestant) in postmortem blood samples. The blood levels of pseudoephedrine ranged from 4,743 ng/mL to 7,100 ng/mL.† One infant (patient 2) had received both a prescription and an over-the-counter cough and cold combination medication at the same time; both medications contained pseudoephedrine (Table 1). The other two infants also had received pseudoephedrine-containing medications (one prescription and one over the counter). Two of the infants (patients 1 and 2) had been administered prescription medications containing carbinoxamine (an antihistamine), although neither had detectable postmortem blood levels of carbinoxamine. Two of the infants (patients 2 and 3) had detectable blood levels of dextromethorphan (a cough suppressant) and acetaminophen (an antipyretic and analgesic).
All three infants were found dead in their homes. Autopsy and medical investigation records were obtained. A medical examiner or coroner determined that cough and cold medication was the underlying cause of death for each of the three. None of the deaths were determined to be intentional. On autopsy, two of the infants (patients 1 and 2) had evidence of respiratory infection; no abnormalities in cardiac pathology were revealed in any of the infants.
Reported by: Pediatric Toxicology Committee and Data Committee, National Assoc of Medical Examiners. A Srinivasan, MD, D Budnitz, MD, N Shehab, PharmD, Div of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases (proposed); A Cohen, MD, EIS Officer, CDC.

Editorial Note:

Cough and cold medications (Table 2) are in widespread use to treat children, and the overall incidence of reported adverse events has been low. An estimated 1,519 children aged <2>2 years, FDA approval of the use of over-the-counter cough and cold medications is based on review of safety and efficacy data by an external advisory review panel. However, in children aged <2>

Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. 21 CFR Part 341 (2006). Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics 2001;108:E52. Marinetti L, Lehman L, Casto B, Harshbarger K, Kubiczek P, Davis J. Over-the-counter cold medications---postmortem findings in infants and the relationship to cause of death. J Anal Toxicol 2005;29:738--43. Boland DM, Rein J, Lew EO, Hearn WL. Fatal cold medication intoxication in an infant. J Anal Toxicol 2003;27:523--6. Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev 2004(4):CD001831. Smith MB, Feldman W. Over-the-counter cold medications. A critical review of clinical trials between 1950 and 1991. JAMA 1993;269: 2258--63. Use of codeine- and dextromethorphan-containing cough remedies in children. American Academy of Pediatrics. Committee on Drugs. Pediatrics 1997;99:918--20. Irwin RS, Baumann MH, Bolser DC, et al. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest 2006 Jan;129(1 Suppl):1S--23S. Food and Drug Administration. Carbinoxamine products; enforcement action dates. Federal Register 2006;71:33462. Hanzlick R. National Association of Medical Examiners Pediatric Toxicology (PedTox) Registry Report 3. Case submission summary and data for acetaminophen, benzene, carboxyhemoglobin, dextromethorphan, ethanol, phenobarbital, and pseudoephedrine. Am J Forensic Med Pathol 1995;16:270--7. * Estimated from the National Electronic Injury Surveillance System--Cooperative Adverse Drug Events Surveillance project, which is jointly operated by CDC, the Food and Drug Administration, and the Consumer Product Safety Commission. † In pharmacokinetic studies of children aged 2--12 years, the mean maximum plasma concentrations of pseudoephedrine after therapeutic doses ranged from 180 ng/mL to 500 ng/mL and were comparable to adults with current dosing regimens (FDA, unpublished data, 2006).

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Date last reviewed: 1/11/2007

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