This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Vivus Identifies Birth Defect Risk Tied to Weight-Loss Drug Qnexa

Updated with analyst comments, new stock price.

MOUNTAIN VIEW, Calif. ( TheStreet) -- The infants of women exposed during pregnancy to a component of Vivus' (VVUS - Get Report) weight-loss drug Qnexa had a higher rate of oral birth defects compared to infants not exposed to the drug during pregnancy, according to interim study results released Wednesday night.

Vivus shares are down $2, or 19%, to $8.33 in Thursday's pre-market session. The drop in Vivus' share price reflects investor concerns that the higher rate of birth defects observed with the Qnexa component may jeopardize the company's efforts at getting the weight-loss drug approved next year.

Peter Tam, Vivus' president, said in a statement that the prevalance of birth defects detected from Wednesday's study were in line with previously reported studies and that the company was sharing the new data with the U.S. Food and Drug Administration.

Vivus, in its Wednesday night announcement, was careful not to draw any conclusions from the birth defect study and didn't say whether the results made Qnexa's approval any more or less likely. The company isn't holding an investor conference call.

Women in the first trimester of pregnancy who took the epilepsy drug topirimate, one of two active ingredients that make up Vivus' Qnexa, were at a two-fold risk of giving birth to a child with a cleft lip or palate compared to women who also took topirimate previously but not during pregnancy.

The actual rate of oral birth defect in women who took topirimate during pregnancy was 0.29% compared to 0.16% in women with prior exposure to the drug.

In another analysis, pregnant women who took topirimate during the first trimester were five times more likely to give birth to a child with an oral birth defect compared to a control group of pregnant women not exposed to topirimate. Here, the actual rate of cleft lips and palate was 0.36% versus 0.07%, although Vivus said the rate of birth defects in the control group of women may be artificially low due to random error.

U.S. regulators have previously issued safety warnings about the risk of cleft lips and palates in children born to women who took topirimate during pregnancy.
1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ARNA $1.72 -2.82%
OREX $0.45 -4.20%
VVUS $1.65 -1.20%
AAPL $93.74 -1.15%
FB $117.58 0.73%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs