Vaginal bleeding

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Medical Subject Headings, Marketing, Artery, Pregnancy, Estetrol, INN, Pearl, Risk, Progesterone, Woman, IIA, ATC, Bleeding, International, Headache, Ageing, Language, Mouth, Tablet, Dysmenorrhea, Acne, Birth control, European Medicines Agency, Blister, Menstrual cycle, Pearl Index, Select, Birth, Patient, Vein, Safety, Cancer, Checklist, Anatomy, Vaginal bleeding, Internal bleeding, Ovulation

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Medical Subject Headings, Marketing, Artery, Pregnancy, Coronary thrombosis, Estetrol, INN, Risk, Pearl, Progesterone, Woman, IIA, ATC, Health system, Bleeding, International, Headache, Ageing, Language, VTE, Mouth, Tablet, Dysmenorrhea, Acne, Birth control, European Medicines Agency, Blister, Menstrual cycle, Pearl Index, Select, Birth, Patient, Vein, Safety, Cancer, Checklist, Anatomy, Vaginal bleeding, Internal bleeding, Ovulation

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Momcozy Gives New Moms Peace of Mind with All-Inclusive Postpartum Recovery Kit

Retrieved on: 
Monday, November 20, 2023
Trauma, Pregnancy, Perineum, Sensation, Pain, Bleeding, Lochia, Sleep, Ice, Human, Mother, Vaginal bleeding, Birth control

Momcozy , a renowned maternity and baby brand with a mission to be moms' best companion, has carefully crafted its best-in-class postpartum recovery kit to provide moms with comfort and convenience and make their postpartum life easier.

Key Points: 
  • Momcozy , a renowned maternity and baby brand with a mission to be moms' best companion, has carefully crafted its best-in-class postpartum recovery kit to provide moms with comfort and convenience and make their postpartum life easier.
  • The Momcozy Postpartum Recovery Kit contains 19 thoughtfully chosen pieces to aid moms during the first days and weeks postpartum.
  • Designed by moms for moms, this kit offers new mothers everything they need to recover comfortably and feel their best after giving birth.
  • New mom Samantha Brown of Seattle says, “The Momcozy Postpartum Essentials Kit was an absolute lifesaver after I gave birth.

Danco Statement on Filing of Cert Petition, September 8, 2023

Retrieved on: 
Friday, September 8, 2023
REMS, Pregnancy, Fifth Circuit Four, Reproductive rights, Bleeding, Allergy, Medication, Diarrhea, Internal bleeding, Pharmacy, Mifepristone, IUD, Gestational age, Misoprostol, Health care, Fever, Danco, Weakness, Woman, Prescription, Angioedema, Prostaglandin, Hypovolemic shock, Patient, Abdominal pain, Sepsis, Rash, Tachycardia, Vomiting, Leukocytosis, Administration, Death, Syncope, Vaginal bleeding, Dizziness, Fungal infection, United States Court of Appeals for the Fifth Circuit, Anaphylaxis, Anemia, Supreme court, Law of the United Kingdom, Nausea, Court, Genetically modified bacteria, FDA, Headache, Hematocrit, Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, Safety, Full, Pharmaceutical industry, Birth control, Vaccine, Dentistry, Nursing, Infection

Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.

Key Points: 
  • Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.
  • The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.
  • The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Danco Statement on 5th Circuit Ruling, August 16, 2023

Retrieved on: 
Thursday, August 17, 2023
REMS, Pregnancy, Reproductive rights, Bleeding, Allergy, Medication, Diarrhea, Internal bleeding, Pharmacy, Mifepristone, IUD, Gestational age, Misoprostol, Health care, Fever, Danco, Weakness, Woman, Prescription, Multimedia, Prostaglandin, Angioedema, Hypovolemic shock, Patient, Abdominal pain, Sepsis, Rash, Tachycardia, Tablet, Vomiting, Leukocytosis, Congress, Death, Administration, Syncope, Vaginal bleeding, Dizziness, United States Court of Appeals for the Fifth Circuit, Fungal infection, Anaphylaxis, Anemia, Supreme court, Nausea, Genetically modified bacteria, FDA, Headache, Hematocrit, Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, Safety, Full, Birth control, Pharmaceutical industry, Vaccine, Dentistry, Nursing, Infection

NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.

Key Points: 
  • NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.
  • Danco remains confident in the safety and effectiveness of Mifeprex® and committed to making the drug available as broadly as possible.
  • Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

How does the new over-the-counter birth control pill, Opill, work to prevent pregnancy? 5 questions answered

Retrieved on: 
Wednesday, July 19, 2023
People, Blood pressure, Vaginal bleeding, Review, Seizure, Insurance, State University of New York, Pregnancy, Headache, Conversation, Thrombus, Bleeding, Thornburgh v. American College of Obstetricians & Gynecologists, Diarrhea, Breast, Pharmacy, Pulmonary embolism, Neoplasm, HIV/AIDS, Progesterone, Binghamton University, Ovulation, Infection, State university system, Woman, Acne, Appetite, Uterus, Hormone, Provisions of the Affordable Care Act, Fatigue, Vomiting, Pharmacist, Food and Drug Administration, Norgestrel, Affordable Care Act, Tuberculosis, Time, Risk, OTC, Vertically transmitted infection, Deep vein thrombosis, Nausea, Growth, American College, FDA, Pulmonary hypertension, Mucus, Safety, Hormonal contraception, Food, Female, Breast cancer, Legislation, Birth control, Pharmaceutical industry

The Food and Drug Administration’s July 13, 2023, approval of the first over-the-counter birth control pill, called Opill, broadens the options for people seeking to prevent pregnancy.

Key Points: 
  • The Food and Drug Administration’s July 13, 2023, approval of the first over-the-counter birth control pill, called Opill, broadens the options for people seeking to prevent pregnancy.
  • When Opill becomes available, presumably in the first quarter of 2024, it will be sold in grocery and convenience stores, in pharmacies and through online retailers.

1. How does Opill work to prevent pregnancy?

    • Opill, like many other progestin-only birth control pills, must be taken at the same time each day to prevent pregnancy.
    • This is because progestin has to stay at a certain level in the body in order to effectively prevent pregnancy.
    • Opill does not prevent sexually transmitted infections, so people looking to further protect themselves should still use some sort of barrier method during intercourse.

2. Is Opill safe to be sold over the counter?

    • The same drug in Opill, norgestrel, has been used safely and effectively for birth control since 1973.
    • In order for a drug to be sold without a prescription in the U.S., it must first be reviewed and approved by the Food and Drug Administration.
    • Several studies have looked at whether women can accurately evaluate their own ability to safely use birth control.

3. Shouldn’t a doctor be involved in choosing birth control?

    • Screenings may include pap test, pelvic examination, clinical breast examination and testing for sexually transmitted diseases.
    • Even before the approval of Opill, people had the option to uncouple their screening examinations from prescription access.
    • In addition, more than 20 states currently allow pharmacists to provide prescription contraceptive based on a self-assessment questionnaire and blood pressure screening.

4.Does Opill have any side effects?

    • Opill does not contain estrogen, as some other hormonal birth control pills do.
    • Estrogen plays a role in menstrual regularity, so people who use Opill may experience more irregular vaginal bleeding.
    • But some individuals who use Opill may have less bleeding or stop bleeding altogether while taking the pills.

5. Will OTC status truly increase accessibility to birth control?

    • The Affordable Care Act currently mandates insurance coverage of certain FDA-approved prescription birth control products, but it does not require coverage of nonprescription options.
    • Lastly, Opill represents only one type of birth control.
    • If 100 women use a birth control that is 91% effective over one year, it is estimated that nine women using that method will become pregnant over that year.

FDA Approves First Nonprescription Daily Oral Contraceptive

Retrieved on: 
Thursday, July 13, 2023
Vaginal bleeding, Pregnancy, Headache, Syphilis, Laboratoires Pierre Fabre, Bleeding, HIV, Center for Drug Evaluation and Research, Prenatal care, Condom, Cancer, Gonorrhea, Cramp, Hepatitis B, Perrigo, Appetite, Abdominal pain, Dizziness, AIDS, Wart, Risk, Child, Norgestrel, Genital herpes, Vertically transmitted infection, Nausea, Bloating, Chlamydia, Amenorrhea, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Breast cancer, Birth control, Pharmaceutical industry

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.

Key Points: 
  • Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • "Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research.
  • "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
  • Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).

Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment

Retrieved on: 
Monday, July 10, 2023
Health, Consumer, Women, Research, Science, Pharmaceutical, Biotechnology, Hypersensitivity, Vaginal bleeding, News, Gonadotropin, Ganirelix, Pregnancy, Anaphylaxis, Society, Ovarian hyperstimulation syndrome, Fresenius (company), American Society for Reproductive Medicine, Parent, Ovulation, LH, Woman, ART, Infertility, Multimedia, USP, Fertilisation, Luteinizing hormone, Abdominal pain, ML, Injection site reaction, Assisted reproductive technology, LaTeX, Patient, Physician, Risk, Injection, Fertility, HCG, SART, Nausea, Gonadotropin-releasing hormone, Reproductive medicine, FDA, Headache, Syringe, Pharmaceutical industry, Birth control, Organon

Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health.

Key Points: 
  • Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health.
  • Ganirelix Acetate Injection is available immediately from Fresenius Kabi in 250 mcg/0.5 mL prefilled syringes.
  • View the full release here: https://www.businesswire.com/news/home/20230710582430/en/
    Now available: Fresenius Kabi Ganirelix Acetate Injection.
  • Ganirelix Acetate Injection is the third product offering in Fresenius Kabi’s Women’s Health portfolio, which includes Chorionic Gonadotropin for Injection, USP (hCG) and Progesterone Injection, USP.

May Health Announces Data From Feasibility Studies of its Novel Ovarian Rebalancing™ Treatment and Receives Approval From FDA for Pivotal Trial

Retrieved on: 
Monday, June 26, 2023
Research, Medical Devices, Women, FDA, Baby, Maternity, Clinical Trials, Health, Consumer, Science, Vaginal bleeding, Area studies, ULTRA, Pregnancy, University, Ovary, Sofinnova, Ovulation, Food and Drug Administration, Clinical trial, Woman, Infertility, Polycystic ovary syndrome, Ultrasound, Pain, Patient, PCOS, Reproductive medicine, Headache, Pregnancy rate, Food, Safety, Birth control, Pharmaceutical industry

Early outcomes data from the ULTRA-EU and ULTRA-US feasibility clinical trials were presented at the 39th Annual ESHRE meeting in Copenhagen, Denmark on June 26, 2023.

Key Points: 
  • Early outcomes data from the ULTRA-EU and ULTRA-US feasibility clinical trials were presented at the 39th Annual ESHRE meeting in Copenhagen, Denmark on June 26, 2023.
  • "The new data show great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications."
  • "The success of these feasibility studies and the FDA's approval of the pivotal REBALANCE study only serve to reinforce our initial conviction.
  • Details of the oral presentation:
    Title: The ULTRA trial: transvaginal ULTRAsound-guided ovarian ablation using the novel May Health device in women with PCOS-related infertility: first–in-human feasibility clinical trial

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

Retrieved on: 
Friday, May 12, 2023
Vaginal bleeding, Infection, Kidney disease, Priority review, Liver, Food, Pediatrics, Diarrhea, Center for Drug Evaluation and Research, Chills, Menopause, Liver disease, Stroke, Skin, Quality of life, Woman, Liver injury, History, Abdominal pain, Hot, Hot flash, Hormone, CYP1A2, Vomiting, Thermoregulation, Insomnia, Back pain, Rare, Patient, Perspiration, Nausea, Progesterone, Research, Reproductive medicine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cirrhosis, Flushing, Safety, Pharmaceutical industry, Birth control

SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.

Key Points: 
  • SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.
  • Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause.
  • "The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women."
  • The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials.