St. Petersburg Times Online: World&Nation
Place an Ad Calendars Classified Forums Sports Weather
Print story Subscribe to the Times

Health in brief

FDA re-examines hot flash drugs

Compiled from Times wires
© St. Petersburg Times
published April 12, 2003

WASHINGTON -- Federal health officials are taking a second look at a treatment for menopausal hot flashes, saying their approval of a hormone combination 27 years ago was not based on substantial evidence.

The Food and Drug Administration said in a statement Thursday that the combination of estrogen and androgen is included in two marketed products, Estratest and Estratest H.S., sold by Solvay Pharmaceuticals of Marietta, Ga.

The FDA said neither of those products has ever received formal approval, although both have been on the market for several years. The company is being asked to submit data to support sale of the drugs.

The agency said it was acting because it "does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products."

Androgens are male sexual hormones, such as testosterone.

The FDA will allow the products to remain available while it undertakes the re-examination of its 1976 approval, the statement said.

Red Cross settles blood safety fines

WASHINGTON -- The Red Cross, accused by the government of "persistent and serious violations" of blood safety rules, promised in a court settlement Friday to meet all safety requirements and pay substantial fines if it fails to do so.

The Food and Drug Administration said the consent agreement settles concerns stemming from inspections during 17 years.

Two years ago, the FDA went to court seeking a contempt citation against the Red Cross for not following a 1993 agreement to meet blood safety standards.

Under the new settlement, fines for various violations could total up to 1 percent of the Red Cross's $1.9-billion in annual revenues -- or $19-million -- in the first year, increasing to a maximum of 4 percent by the fourth year, the FDA said.

"The new financial penalties in the consent decree create an important new incentive for (the American Red Cross) to improve the processes and controls necessary for making safer blood products," said FDA Commissioner Dr. Mark B. McClellan.

Red Cross officials could not be reached for comment on the agreement.

The Red Cross provides about 45 percent of the nation's blood supply. Another 45 percent is collected by independent blood centers and the rest is collected at hospitals.

McClellan said other blood centers have been able to avoid the type of chronic problems that have plagued the Red Cross.

Print story Subscribe to the Times

Back to World & National news
Back to Top

© 2006 • All Rights Reserved • Tampa Bay Times
490 First Avenue South • St. Petersburg, FL 33701 • 727-893-8111
Special Links
Susan Taylor Martin

From the Times wire desk
  • Iraq: Arlington burying its first casualties of war
  • Iraq: Changing Baghdad's doormat
  • Iraq: Tikrit battle looms, but Iraqis start to flee
  • Iraq: All semblance of control vanishes
  • Iraq: Treading cautiously amid chaos
  • Iraq: Policing the peace is just part of war
  • Iraq: Troops dealt an old tool
  • Cuba executes hijackers after month of crackdowns
  • Soldiers are forced to surrender their spoils of war
  • Inspector: Nuclear find overblown
  • Fighting terror: Congress approves vaccine compensation
  • Franks: Afghan fight informs new war
  • 'Cole' bombing suspects escape from Yemeni prison
  • Congress negotiates budget outline
  • Nation in brief: Ammonia explosion kills worker
  • Health in brief: FDA re-examines hot flash drugs
  • VA heart attack care worse than Medicare, study finds
  • World in brief: Nine new SARS cases hospitalize travelers

  • From the AP
    national wire
    From the AP
    world desk