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New Class of Drugs Might Cause Congenital Heart Defects


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But there appears to be time to investigate the danger of birth defects, because none of the new agents seem to be in human trials yet, Force said. "I have checked on clinical trials, and I did not see anything there yet," he said.

The kind of animal study that his group has done can help determine whether there is danger, Force said. "Probably more work needs to be done on the basic level with these agents and their effect on embryonic development before we start giving them to women of childbearing age," he said. "Before they are given to women of childbearing age, they should be tested in animal models."

There are published reports of various GSK-3 inhibitors showing promise against diabetes, pancreatic cancer, leukemia, Alzheimer's disease and other dementias. Those reports do not mention human trials, planned or ongoing, that would require assessment of the risk of birth defects.

Text Continues Below



"The last thing I want to do is scare people," Force said. "I'm saying this is something we should be aware of as these drugs come out."

One expert said having a mouse model for this purpose should prove useful.

"It's always important to have tools like this mouse model to look at teratogenicity [birth defects], irrespective of specific drug families," said Dr. Peter J. Nelson, an assistant professor of medicine at New York University. His research centers on compounds that affect both GSK-3 and another family of proteins, cyclin-dependent kinases.

"We're looking primarily at renal disease," Nelson said. "It's in a very preclinical state."

More information

Use and known side effects of lithium are described by the U.S. National Library of Medicine.

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Last updated 10/2/2008

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SOURCES: Thomas Force, M.D., professor, medicine, Thomas Jefferson University, Philadelphia; Peter J. Nelson, M.D., assistant professor, medicine, New York University; October 2008, Journal of Clinical Investigation


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