UPDATE 2-US FDA staff urge review of Abbott drug risks
* 6 reports of developmental delays in children - FDA memo
* Reports collected since Depakote's approval in 1983
* Unclear if anti-seizure drug played a role
* Abbott says will work with FDA to evaluate risks (Adds Abbott comment, detail on drug, sales figures)
By Lisa Richwine
WASHINGTON, June 19 (Reuters) - U.S. drug reviewers have recommended additional study of delayed development reported in children of mothers who took Abbott Laboratories' (ABT.N) anti-seizure drug Depakote.
Six cases received since its approval in 1983, including two siblings reported to have autism, "raise concerns," Food and Drug Administration staff wrote in a May 6 memo released on Friday.
Limitations in the reports "make it impossible to definitively conclude" the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.
"Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children," they added.
Depakote, known generically as divalproex, is approved for treating epilepsy and mania associated with bipolar disorder and for preventing migraines.
The drug already carries a strong "black box" warning that it may cause birth defects. In the six cases of developmental delays, no defects were reported at birth, FDA reviewers said.
Abbott will "continue to participate in discussions with the FDA and its advisers to further evaluate any risks related to anti-epileptic drugs, neurodevelopment and pregnancy," spokeswoman Raquel Powers said.
"For many women, Depakote may be the only effective medicine to control their seizures" and doctors and patients should evaluate the drug's risks versus its benefits, Powers said.
Depakote was once a blockbuster for Abbott but sales dropped sharply after generic competitors became available. First-quarter sales for the drug were $110 million.
The FDA staff memo was released ahead of an advisory panel meeting, scheduled for Tuesday, where outside experts will review the safety of various drugs for children.
Abbott shares were little changes, up 5 cents to $47.71 in late morning trading on the New York Stock Exchange.
The FDA posted the staff memo here. (Reporting by Lisa Richwine; Editing by Brian Moss and Tim Dobbyn)
- Tweet this
- Share this
- Digg this