Canadian health officials call for relabeling of cough-cold remedies
OTTAWA Health Canada on Thursday announced that manufacturers will need to re-label over-the-counter cough and cold medicines that have dosing information for children to indicate that these medicines should not be used in children under the age of six. The decision came after Canada’s drug regulatory agency reviewed the category and could be a preview of what might be in store in the United States—the Food and Drug Administration is expected to announce any proposed changes to monographs governing seven key over-the-counter cough/cold ingredients used in pediatric formulations in September of 2009.
The re-labeling of these medicines will be completed by fall 2009, in time for the next cough and cold season, the Canadian agency stated. “During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under six, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products,” the agency said.
“Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children,” the agency added. “In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under six.”
“Families have relied on cough and cold medicines to comfort their children for more than 30 years,” said Bill Murphy, vice president OTC, Latin America and Canada, McNeil Consumer Healthcare. “McNeil Consumer Healthcare has always encouraged the appropriate use of these medicines and these actions will further support parents and caregivers as they care for children with colds.”
“Children’s over-the-counter cough and cold medicines continue to be safe and effective when used as directed,” commented Linda Suydam, president of the Consumer Healthcare Products Association, in response to Health Canada’s decision. “Today’s decision by Health Canada has no impact on medicines in the United States,” she said.
“FDA has always taken a conservative approach when examining the risk-to-benefit ratio of medicines available in the United States. In October 2008, FDA indicated that its suggestion to U.S. manufacturers to re-label OTC childrens oral cough and cold medicines to read do not use in children under age four stems from a close look at all available data. In addition, the agency expressed its support of drug makers efforts to voluntarily modify directions advising parents not to use pediatric OTC oral cough and cold medicines in children under age four.”
Suydam referenced industry’s announcement in October to re-label all pediatric OTC cough/cold remedies sold in the U.S. not to be used in children under the age of four. That re-labeling is currently ongoing.
Women’s Health announces additions to executive team
AVON, Conn. Women’s Health USA announced Thursday promotions that would affect the make-up of its executive team.
Women’s Health has said that Patrick Murphy will serve as president and COO, reporting to Robert Patricelli, chairman and CEO.
Murphy rececently served at Women’s Health as EVP and serves concurrently as SVP and CFO of Evolution Benefits a companion company to Women’s Health.
Additionally, Brian Pskowski has been promoted to the role of EVP of finance and administration Women’s Health subsidiary In Vitro Sciences. Prior to this promotion, Pskowski served as Women’s Health’s CFO for several years, reports said.
And Michael Pascetta has been tapped for SVP and CFO of Women’s Health, taking over for Pskowski. Pascetta has served Women’s Health as CFO of an operating divisions for four years.
GlaxoSmithKline begins phase 3 trial for coronary heart disease treatment
LONDON GlaxoSmithKline has started its first phase 3 clinical trial to determine the efficacy of the investigational Lp-PLA2 inhibitor darapladib, for adults with chronic coronary heart disease, GSK announced Thursday.
The Stabilization of Atherosclerotic Plaque By Initiation of Darapladib Therapy, or STABILITY study, will include more than 15,000 patients from 39 studies.
“Despite major advances in medical treatment, coronary heart disease remains the leading cause of death worldwide, and new approaches are needed to help reduce this burden to patients and society,” GlaxoSmithKline senior vice president for drug discovery Patrick Vallance said in a statement. “GSJ is initiating the large STABILITY trial with darapladib as part of a phase 3 program to determine if this novel medication could improve people?s lives by reducing the risk of cardiovascular events.”