FDA: More study needed on J&J birth control patch

WASHINGTON (Reuters) – Further evaluation is needed to
understand the blood clot risk for women associated with
Johnson & Johnson’s birth control patch, U.S. regulators said
on Friday.

The Food and Drug Administration does not plan to take any
action based on early results of a study showing patch users
were twice as likely to develop blood clots than others who
took a birth control pill, said Dr. Daniel Shames, director of
the FDA’s division of reproductive and urologic drug products.

A second study showed the chances of a blood clot were
similar for women who took either the patch or the pill,
Johnson & Johnson and the FDA said.

“We should caution that these results are preliminary and
further evaluation is necessary to understand what these
results mean,” Shames told reporters.

Shares of J&J fell as low as $58.74 before reversing
direction to trade up 25 cents at $59.23 in late morning
trading.