When Health Canada ruled in 2008 that children under age 6 should not be given over-the-counter cough and cold remedies, it probably didn't realize it was creating a whole new market for medications aimed at kids.
Companies that use certain active ingredients in over-the-counter medications, such as dextromethorphan (used in cough remedies) and brompheniramine maleate (used in cold meds), now must carry labels indicating they are not to be given to children under age 6.
But the recent ruling, made because there is little proof that these products work in children and evidence they can cause rare side effects or lead to overdose, doesn't apply to makers of natural or homeopathic medicine.
Now, many of those companies are rushing to fill the void and attract a following from confused parents looking for ways to help their sick children in the wake of Health Canada's restrictions on traditional remedies.
The makers of COLD-FX, a Canadian natural health product designed to help boost the immune system to prevent or reduce cold and flu symptoms, are launching a clinical trial in hopes of potentially marketing their product to children.
"If we end up with results that say our product is not only safe for children to use, but effective for children to use, it would put us in a good position to … create some other conditions in which we could market to a pediatric population," said Michael McDougall, senior manager of media relations with Afexa Life Sciences Inc., which makes COLD-FX.
At the same time, Boiron Canada, part of an international homeopathic company, has begun promoting several products it says can relieve cold and flu symptoms and aren't included in Health Canada's restrictions on cough and cold medications.
Hyland's Homeopathic Canada, a division of U.S.-based Standard Homeopathic Co., sells a flu-care kit that it says can relieve fever, chills, aches, congestion and other symptoms in kids.
Companies selling natural or homeopathic cold and flu medications for children highlight that they offer safe alternatives to over-the-counter medications that have been restricted for use in children by Health Canada.
"They're both safe and effective and they work in a completely different mechanism than the traditional cough and cold medicines that we used to give to kids," said Farid Wassef, a pharmacist and paid spokesman for Boiron Canada.
But there are fears some natural products could come with unwanted side effects or risks, and questions over whether they have any effect in helping children. Some medical experts in Canada have raised concerns over the use of natural health products in children, saying not enough is known about safety, such as whether the products could have dangerous interactions with medications or other natural health products.
A Canadian study published in the Journal of Pediatrics in 2007 found that many children who ended up in the emergency department of a Toronto hospital were taking more than one natural health product simultaneously, as well as mixing medication and natural health products. Up to 25 per cent of those interactions could lead to potentially harmful effects, the researchers said.
At the same time, some medical experts say the bar used by Health Canada to approve natural products is much lower than the one used for drugs, meaning that even if there isn't ample proof a product works, it could still get onto the market. In addition homeopathic remedies are often diluted, leaving some critics to question whether they contain enough of an active ingredient to be effective.
The Canadian Paediatric Society's position statement on homeopathic medication in children outlines several major concerns. The society said that the quality of studies used to evaluate homeopathy are typically quite poor and that children treated with homeopathic medicine may delay traditional treatment, which could put the child's health in jeopardy. The position statement also emphasizes concerns with other complementary or alternative treatments, which could include natural health products.
The position statement says, "more rigorous studies showing efficacy need to be completed before [homeopathy]can be recommended as a credible complementary or alternative therapy for the pediatric population."