Dosing errors and accidental ingestions of over-the-counter paediatric cough and cold drugs for kids is dangerous.
Don’t use cough mixture to make a child sleepy
THE new advice is, don´t use over-the-counter paediatric cough and cold drugs for kids younger than the age of four. That is the message that leading makers of such drugs are putting on their product labels.
The label change comes after consulting with the American Food and Drug Administration (FDA) which has been reviewing the safety of such drugs.
However, it is important to note that the FDA did not order the label change. Drug makers did that voluntarily.
“Parents should follow, very carefully, the directions on the package and not give children multiple products at the same time,” says Janet Woodcock, MD, director of the FDA´s Centre for Drug Evaluation and Research.
Non-prescription paediatric cough and cold medicines are covered by rules that date back 30-40 years. Modern studies of the drugs – including clinical trials in children – are needed, a process that may take several years.
The issue isn\´t necessarily an ingredient in the drugs. It could be more to do with dosing errors. Paediatric cough and cold drugs are “safe and effective when used as directed\”. However, dosing errors and accidental ingestions are “the leading causes of rare, adverse events in young children”.
In the United States, about 7,000 children under 11 go to emergency rooms each year after taking cough and cold medicines, according to the Centre for Disease Control (CDC). Roughly two-thirds of these occurred after children drank medication unsupervised, according to the CDC.
The new labels will start showing up on store shelves this year. In January, the FDA urged parents and caregivers not to give these drugs to kids younger than two. Drug makers soon voluntarily took over-the-counter infant cough and cold drugs off the market.
Making kids sleepy
Don´t use drugs containing antihistamines to sedate or make a child sleepy. Paediatric cough and cold drug makers are voluntarily adding language to that effect to the label of products containing certain antihistamines.
The following key points are stressed to parents, caregivers, and health-care providers:
Follow the dosing recommendations exactly and use the measuring device provided.
Do not give a medicine only intended for adults to a child.
Do not use two medicines at the same time that contain the same ingredients.
Prevent unsupervised ingestions by keeping all medicines out of the reach and sight of children.
Do not use antihistamine products to make a child sleepy.
Consult a physician or health-care professional with questions.
Aged under two Last year, the FDA warned consumers not to give cold medicines to children under age two because of serious and possible life-threatening side effects. Now officials are considering limiting sales of products intended for children up to the age of six. The agency´s options range from stricter labelling and packaging requirements to banning companies from marketing products targeted for young children at all.
Joshua Sharfstein, MD, the Baltimore City Commissioner of Health, urged FDA officials to take off the market cough and cold medicines for children under six.
“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,\” he said.
The agency is also considering moving children\´s cold medicines from over-the-counter status to prescription-only sales.
Lack of data on cold remedies
Most available cold remedies use combinations of different active ingredients, and most have not been well-tested in young children.
But several experts told the FDA recently said that cold medicines have shown little benefit for children\´s cold symptoms, which usually clear up on their own without medicine.
“The available data show cough and cold products to be ineffective for children with cough and cold symptoms. In the absence of evidence of efficacy, any risk associated with these drug therapies is unacceptable,\” said David Bromberg, MD, a paediatrician from Frederick, Maryland.
So what do you do for a cough? There are lots of natural remedies and old grandmother\´s recipes.
Here\´s one that involves stuff that you may find in your kitchen – honey and garlic – and some sunlight.
1. Peel a handful of garlic pips
2. Crush lightly
3. Add to a jar of honey
4. Seal the jar tightly
5. Leave by the window where it can get sunned regularly
6. Allow to stand for two weeks. This can then be kept in a refrigerator for better long-term preservation.
The dosage for both dry and productive cough is one to three teaspoons, two to three times a day. After consuming this formula, do not drink or eat to allow the \”cough syrup\” to remain in the throat area for a little longer.
Honey has a powerful demulcent (soothing) effect on the throat. Garlic, especially when \”aged\” and \”sunned\”, is activated and becomes one of Nature\´s most powerful antiseptic formulas.
Another simple treatment to break thick and stubborn mucus is warm salt water. Water is a powerful immune stimulant. Warm water makes you sweat and this too wakes up a sluggish immune system. Salt is used both to \”dilute\” and \”break\” your phlegm. That is why phlegm is somewhat salty.
Like all illnesses, parents need to be alert. Fever is a bad thing and needs to be looked into. Thick and greenish mucus indicates an infection. These symptoms demand that a doctor be consulted. Tell the doctor that you need medical support and guidance and that you only use medicine as a last result. There is an old joke that goes like this – a flu is cured in seven days. However, if you see a doctor, it will take a week.
Source : New Straits Times
By : Rajen M.
27 Apr 2010