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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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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NIH discusses ways to tackle digestive diseases

BY Michael Johnsen

WASHINGTON The National Institutes of Health announced last week the release of the first long-range plan for tackling digestive diseases, which affect as many as 70 million Americans each year.

Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases described the impact of diseases ranging from food-borne infections to cancer and liver failure, and mapped out priorities for research over the next 10 years.

“NIH-funded research has led to tremendous discoveries in peptic ulcer disease, viral hepatitis and colorectal cancer,” stated Griffin Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases division of the NIH. “To build on these advances and break new ground, we’ll be looking for investigator-initiated projects and developing new initiatives that respond to the commission’s recommendations.”

An estimated 20 NIH institutes, centers and offices invested more than $1.4 billion in digestive diseases research in fiscal year 2008. Current studies focus on understanding the fundamental mechanisms of digestive system development and function, as well as basic, translational and clinical research on the digestive system in normal and disease conditions.

According to NIH, each year approximately 105 million visits to doctors’ offices are for digestive diseases, often driven by symptoms such as stomach pain, diarrhea, vomiting or nausea. The diseases cost the United States $100 billion in direct medical costs every year. Prescription drugs for diseases such as gastroesophageal reflux are among the most commonly prescribed medications in the United States.

The report emphasizes the importance of cross-cutting research, encouraging multidisciplinary efforts to advance understanding of causes and improve diagnosis and treatment of digestive diseases. The high-impact goals recommended by the commission include:

  • Better understanding of basic biology of the digestive system;
  • Improving the understanding of functional gastrointestinal disorders and motility disorders such as irritable bowel syndrome;
  • Identifying additional infection-causing microbes;
  • Improving treatments for the diverse diseases of the stomach and small intestine; and
  • Developing more efficient ways to categorize diseases of the colon and rectum, among other goals.

The report can be found online at: http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/NCDD/FinalResearchPlanPosting.htm.

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