понедельник, 8 октября 2012 г.

CHPA comments on US FDA's public meeting on pediatric cough/cold medicines. - Nutraceuticals International

CHPA comments on US FDA's public meeting on pediatric cough/cold meds

The US Food and Drug Administration has rejected calls made at a public hearing on pediatric over-the-counter cough and cold medicines for a ban on products aimed at children aged between two to six years old. The federal agency warned that such a move could backfire, but there are concerns about the lack of scientific evidence to support the use of cough and cold drugs for children.

In response, the Consumer Healthcare Products Association said it is pleased that the FDA continues to gather information surrounding children's OTC cough and cold medicines, saying 'the makers of OTC oral pediatric cough and cold medicines have developed a multi-year plan specifically designed to help improve the safe use of these products and reaffirm the efficacy of these medicines. The leading makers of these medicines remain committed to working with FDA and pediatric experts to ensure that parents and caregivers continue to have appropriate treatment choices for their children.'

Also reacting to the news was French company Boiron, which has launched a range of homeopathic products in the USA to address these concerns (see page xx).

In its statement, the CHPA said the makers of these medicines have begun implementation of a 'ground-breaking, comprehensive program. The initiative will advance the science, confirm effectiveness, enhance packaging and dosing technologies, and reach millions of parents, caregivers and health care providers with valuable information and education on the proper use and storage of OTC oral pediatric cough and cold medicines.' This program includes:

- a comprehensive and scientifically rigorous efficacy and safety program for children aged two to under 12 to advance the science and ensure the highest level of scientific rigor. This program includes pharmacokinetic studies to confirm the dosing for the eight most commonly used OTC oral cough and cold ingredients. Once these dosing studies are finalized, it will begin its research to revalidate the effectiveness of these medicines;

- continued collection and review of available safety data. A comprehensive safety review in 2007 and data from the US Centers for Disease Control and Prevention show that the majority of adverse events associated with OTC oral pediatric cough and cold medicines are a direct result of accidental ingestion. Reducing these preventable errors is the cornerstone of the CHPA's national educational program; and

- a comprehensive, national education program which to date has reached more than 100 million parents and caregivers and will reach even more over the next year. The campaign focuses on the root causes of adverse events and speaks directly to parents, day care and health care providers, and other caregivers. The CHPA is partnering with a number of organizations in these efforts, including the American Pharmacists Association and the American Association of Family Physicians. These education campaigns will underscore the importance of following the directions on the label, using the correct dose, storing medicines safely and consulting with a doctor if there are any questions.

'The leading makers of pediatric OTC cough and cold medicines look forward to continuing their work with the Food and Drug Administration as well as the health care community to ensure that parents have continued access to these safe and effective treatment options for their families,' the CHPA concluded..