HEALTH

Study reveals babies born to smokers have increased risk of SIDS

BY Michael Johnsen

VICTORIA, Australia Monash University researchers have found that babies born to a mother who smokes are more likely to be slower to wake or respond to stimulation – and this may explain their increased risk of Sudden Infant Death Syndrome, researchers reported last week.

Scientific director of the Ritchie Centre for Baby Health Research Rosemary Horne and researcher Heidi Richardson compared babies of mothers who smoked both during the pregnancy and after the baby was born, with babies who lived in a smoke-free environment.

Horne said the study suggested that maternal smoking can impair a baby’s ability to respond to external stimuli, which may explain their increased risk of SIDS.

“Those babies whose mothers smoked did not have as many arousals overall and the progression of the arousal response through the brain was also impaired,” Horne said. “Mothers who smoked while pregnant and continued to smoke afterward significantly increased their baby’s chances of succumbing to SIDS.”

The study involved 12 healthy, full-term infants born to mothers who smoked an average of 15 cigarettes per day. Their arousal responses during daytime sleep were monitored and compared with that of healthy infants who were born to non-smoking mothers.

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FDA to host meeting regarding ‘economically motivated adulteration’

BY Michael Johnsen

WASHINGTON The Food and Drug Administration on May 1 will host a meeting around “economically motivated adulteration,” the association announced Monday through the Federal Register.

“The purpose of the meeting is to stimulate and focus a discussion about ways in which the food (including dietary supplements and animal food), drug, medical device and cosmetic industries, regulatory agencies and other parties can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk,” the agency stated.

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Zegerid new formulation filed; OTC switch of original still in play

BY Michael Johnsen

SAN DIEGO Santarus, a specialty pharmaceutical company, on Monday announced that the Food and Drug Administration has accepted for filing the company’s drug application for a new tablet formulation to add to its Zegerid (omeprazole/sodium bicarbonate) family of branded prescription pharmaceutical products.

“In late January, we submitted to the FDA an NDA for an immediate release tablet formulation of Zegerid, which combines omeprazole with a mix of buffers,” Gerald Proehl, Santarus president and CEO, told analysts last month. “We believe this new tablet has the potential to provide features and benefits that … will be important to physicians and their patients with GERD. Our objectives [are] to have the new Zegerid tablet product commercially available in the United States in the fourth quarter of 2009.”

Pursuant to Prescription Drug User Fee Act guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by Dec. 4.

In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.

On a separate front, Schering-Plough, in partnership with Santarus, is currently seeking to switch the current Zegerid formulation (20-mg) from prescription-only to over-the-counter. Schering-Plough HealthCare Products received a Complete Response Letter regarding that switch application in January.

“Santarus believes that the response will be based on further analysis of existing data,” Proehl said. “While we can’t predict with certainty what the FDA will require if the analysis of the existing data is acceptable to the FDA, Santarus does not believe there will be a need for any additional clinical study.”

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