FDA News Releases
On Women's Health Issues

Archive: 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

2004

• Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection (Nov. 17)
• FDA To Announce Important Labeling Changes for Mifepristone (Nov. 15)
• FDA Approves New Device to Treat Uterine Fibroids (Oct. 22)
• September is National Menopause Awareness Month! (Sept. 29)
• FDA Notifies Patients of Mammography Problems at Ecumed Health Group Facility in Hialeah, Florida (Aug. 23)
• FDA Analyses Finds Ground Castor Beans - Not Purified Ricin -- in Two Tampered Baby Food Jars In Irvine, California Case (July 28)
• FDA Alerts Consumers About Adverse Events Associated With "Permanent Makeup" (July 2)
• FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production (June 7)
• FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval (May 7)
• FDA Updates Zelnorm Labeling with New Risk Information (April 28)
• FDA and EPA Announce the Revised Consumer Advisory on Methylmercury in Fish (March 19 )
• FDA Plans to Evaluate Results of Women's Health Initiative Study for Estrogen-Alone Therapy (March 2)
• FDA Updates Hormone Therapy Information for Post Menopausal Women (Feb. 10)
• FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site (Feb. 4)
• FDA Provides Pathway for Sponsors Seeking Approval of Breast Implants (Jan. 8)

2003

• FDA's Office of Women's Health Awards 5-Year Research Contracts (Nov. 5, 2003)
• FDA Approves Estrasorb For Treatment of Menopausal Hot Flashes (October 10, 2003)
• Recall of Nortrel 7/7/7 Oral Contraceptive (July 11, 2003)
• WHIMS Study on Estrogen/Progestin (May 27, 2003)
• FDA Revises Finding on Estrogen/Androgen Combination Products in the Treatment of Hot Flashes (April 10, 2003)
• FDA Approves Expanded Use of HPV Test (March 31, 2003)
• FDA Approves Lower Dose of Prempro, a Combination Estrogen and Progestin Drug for Postmenopausal Women (March 14, 2003)
• FDA Proposes New Warning for Over-the-Counter Contraceptive Drugs Containing Nonoxynol-9 (Jan. 16, 2003)
• FDA Approves New Labels for Hormone Therapy for Postmenopausal Women (Jan. 8, 2003)

2002

• FDA Proposes Advisory Label on Products Containing AHA (Dec. 4, 2002)
• FDA Approves New Treatment for Parasitic Infections in Pediatric Patients (Dec. 2, 2002)
• FDA Approves Non-Stimulant ADHD Drug (Nov. 26, 2002)
• FDA Approves Teriparatide to Treat Osteoporosis (Nov. 26, 2002)
• FDA Clears Device to Treat Fibroids (Nov. 26, 2002)
• New Lab Test Screens Pregnant Women for Group B Strep (Nov. 18, 2002)
• FDA, Pharmacia Update Bextra Label with New Warnings (Nov. 15, 2002)
• FDA Approves New Female Sterilization Device (Nov. 6, 2002)
• FDA's Office of Women's Health Announces 2002 Research Contracts (Oct. 1, 2002)
• FDA and FSIS Issue Health Advisory About Listeria (Sept. 13, 2002)
• Gonorrhea Test Kits Recalled By Abbott Laboratories (Aug. 30, 2002)
• FDA Approves GlucoWatch for Children With Diabetes (Aug. 27, 2002)
• Update on Advisory for Norplant Contraceptive Kits (July 26, 2002)
• FDA Approves First Treatment for Women with Constipation-Predominant Irritable Bowel Syndrome (July 24, 2002)
• FDA Approves Restricted Marketing of Lotronex (June 7, 2002)
• FDA Clears New Device for Radiation Treatment for Breast Cancer (May 6, 2002)
• Dietary Supplement Firm Signs Consent Decree with FDA to Stop Selling Product Containing Ephedrine Hydrochloride (April 15, 2002)
• FDA Warns About Possible Enterobacter Sakazakii Infections in Hospitalized Newborns Fed Powdered Infant Formulas (April 12, 2002)
• Kava-containing Dietary Supplements Linked to Serious Liver Toxicity (March 26, 2002)
• FDA Issues Nationwide/International Alert on Potentially Dangerous OB/GYN Surgical Devices (March 14, 2002)
• FDA Announces Foods Advisory Committee to Meet on Methyl Mercury in Seafood (March 1, 2002)
• Brenda J. Holman Promoted to Rear Admiral (Jan. 4, 2002)

2001

• FDA Warns Consumers Not to Use the Dietary Supplement Lipokinetix (Nov. 20, 2001)
• FDA Approves First Hormonal Contraceptive Skin Patch
  (Nov. 20, 2001)
• FDA Approves New Anti-Adhesion Treatment for Gynecologic Surgery (Nov. 19, 2001)
• FDA Announces Changes to the Risk Management Program to Prevent Birth Defects Caused by Accutane (Oct. 31, 2001)
• FDA Approves First Hormonal Vaginal Contraceptive Ring (Oct. 3, 2001)
• FDA Funds Research on Prescription Medications Used by Pregnant Women (Sept. 28, 2001)
• FDA Approves Xeloda in Combination with Taxotere for Advanced Breast Cancer (Sept. 10, 2001)
• Linda Tollefson, D.V.M., Promoted to Rear Admiral (Aug. 15,
  2001)
• FDA Updates Safety Information for Miconazole Vaginal Cream and Suppositories (March 5, 2001)
• FDA Announces Advisory on Methyl Mercury in Fish (Jan. 12, 2001)
• FDA Approves Femara as First-Line Therapy for Advanced Breast Cancer (Jan. 10, 2001)
• FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy With Zerit and Videx in Pregnant Women (Jan. 5, 2001)

2000

• Glaxo Wellcome Decides to Withdraw Lotronex From the Market (Nov. 28, 2000)
• FDA's Dr. Frances Kelsey To Be Inducted into National Women's Hall of Fame (Oct. 6, 2000)
• Update of Advisory for Several Lots of Norplant Contraceptive Kits (Sept. 13, 2000)
• FDA Creates Medication Guide for Lotronex: Health Professional Labeling Revised to Help Manage Risk (Aug. 24, 2000)
• FDA Approves Fluoxetine to Treat Premenstrual Dysphoric Disorder (July 6, 2000)
• Two Firms Get FDA Approval to Continue Marketing Saline-Filled Breast Implants (May 10, 2000)
• FDA Clears New Female Sexual Therapy Device (May 10, 2000)
• FDA Issues Approvable Letter for Mifepristone (Feb. 18, 2000)
• FDA Approves Irritable Bowel Syndrome Treatment for Women (Feb. 9, 2000)
• FDA Approves First Digital Mammography System (Jan. 31, 2000)

1999

• FDA Encourages Women to "Take Time to Care--Nationwide Education Campaign on the Safe Use of Medicine (Sept. 30, 1999)
• FDA Study Finds Possible Link Between Down Syndrome and Lower Maternal Folic Acid Levels (Sept. 28, 1999)
• FDA Approves New Chemotherapy Agent to Treat Breast Cancer (Sept. 16, 1999)
• Mobile X-Ray Owner Sentenced in Mammogram Fraud Case (Sept. 14, 1999)
• FDA Approves Vioxx for Osteoarthritis, Pain and Menstrual Pain (May 21, 1999)
• Mammogram Law Takes Effect April 28 (April 27, 1999)
• FDA Approves Orlistat for Obesity (April 26, 1999)
• FDA Approves New Breast Imaging Device (April 19, 1999)

1998

• Tamoxifen Approved for Reducing Breast Cancer Incidence (Oct. 29, 1998)
• FDA Approves Application for Preven Emergency Contraceptive Kit (Sept. 2, 1998)
• FDA/CDER Thalidomide Information
• Mentor Agrees to Comply with FDA Requirements for Breast Implant Manufacturing (May 5, 1998)
• FDA Approves Xeloda for Breast Cancer (April 30, 1998)

1997

• Questions and Answers about Withdrawal of Fenfluramine (Pondimin) and Dexfenfluramine (Redux) (Sept. 18, 1997)
• FDA Announces Withdrawal of Fenfluramine and Dexfenfluramine (Fen-Phen) (Sept. 15, 1997)
• FDA Warns Consumers on Dangerous Products Promoted on the Internet (June 17, 1997)
• FDA Proposes Safety Measures for Ephedrine Dietary Supplements (June 2, 1997)
• FDA Statement on Generic Premarin (May 5, 1997)
• FDA Calls for Applications for Emergency Use of Oral Contraceptives (Feb. 24, 1997)

1996

• P96-3: Folic Acid To Fortify U.S. Food Products to Prevent Birth Defects (Feb. 29, 1996