Make us your home page
Instagram

Today’s top headlines delivered to you daily.

(View our Privacy Policy)

FDA approves return of drug for morning sickness

WASHINGTON — A treatment pulled off the market 30 years ago won Food and Drug Administration approval again Monday as the only drug specifically designated to treat morning sickness.

That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.

Monday's decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name — Diclegis — as a safe and effective treatment for this pregnancy rite of passage.

In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.

"Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.

U.S. sales of Diclegis are expected to begin in June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under the name Diclectin.

FDA approves return of drug for morning sickness 04/08/13 [Last modified: Monday, April 8, 2013 10:46pm]
Photo reprints | Article reprints

Copyright: For copyright information, please check with the distributor of this item, Associated Press.
    

Join the discussion: Click to view comments, add yours

Loading...
  1. Can the Bad Boys Mowers Gasparilla Bowl thrive in competitive sports market?

    Business

    ST. PETERSBURG — It's a funky name: the Bad Boys Mowers Gasparilla Bowl. But the new sponsors for the former St. Petersburg Bowl might need more than an eye-catching name to create a thriving, profitable contest.

    NC State head coach Dave Doeren clutches the championship trophy after winning the Bitcoin Bowl at Tropicana Field in St. Petersburg in 2014. Bowl organizers are changing the name of the game to the Bad Boy Mowers Gasparilla Bowl.
[

MONICA HERNDON | TIMES]
  2. Dirk Koetter says Bucs used team meeting to discuss social issues

    Bucs

    Four days before their preseason home opener against the Cleveland Browns, which had 12 players not stand for the national anthem prior to their last game, the Bucs used their team meeting to discuss social issues that might have led to that demonstration, coach Dirk Koetter said.

    "The main thing is we have to respect everybody's opinion," Dirk Koetter said, "because everybody is not going to agree." [AP photo]
  3. Rookie tight end Antony Auclair making case to stick with Bucs

    Bucs

    Don't let his modest preseason stats fool you: Antony Auclair, the undrafted rookie tight end from Canada is making a strong case to stick around on the Bucs' 53-man roster this season.

    Bucs tight end Antony Auclair (82) collides with a defender following a catch during training camp. [CHARLIE KAIJO   |   Times]
  4. Who is that 'Blacks for Trump' guy standing behind the president at his Phoenix rally

    National

    At a number of political rallies over the last two years, a character calling himself "Michael the Black Man" has appeared in the crowd directly behind Donald Trump, impossible to miss and possibly planted.

    Michael the Black Man, variously known as Michael Symonette, Maurice Woodside and Mikael Israel, holds up a sign as President Donald Trump speaks to a crowd at the Phoenix Convention Center during a rally on Tuesday in Phoenix, Arizona.  [Ralph Freso | Getty Images]
  5. Off-duty Manatee County deputy saves couple from burning car

    Public Safety

    MANATEE COUNTY — Neil and Claudia Cook are lucky to be alive after an off-duty deputy spotted them trapped in their smoking car and rescued them just before it became engulfed in flames on …

    Neil and Claudia Cook were trapped in their smoking car on Sunday when an off-duty deputy kicked out the window, rescuing them just before the car became engulfed in flames. [Courtesy of Manatee County Sheriff's Office]