US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits

      Summary Company Announcement Date: January 30, 2023 FDA Publish Date: … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Drug Recalls / CellCept – Mycophenolate Mofetil and Increased Risk of Miscarriages and Birth Defects

CellCept – Mycophenolate Mofetil and Increased Risk of Miscarriages and Birth Defects

October 30, 2007 By E. Sizemore 1 Comment

The US Food and Drug Administration (FDA) today issued an alert to healthcare professionals about the dangers associated with Roche’s CellCept (Mycophenolate Mofetil) including “increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.”

The findings come from post marketing data minded from the US National Transplantation Pregnancy Registry, as well as information collected in women exposed to systemic mycophenolate mofetil during pregnancy.

The FDA has deemed that CellCept’s risk category be upgraded from C (risk is possible) to D (positive evidence of fetal risk).

At this point it does not look like CellCept is being recalled (the drug is important to a lot of people, and has a very limited use), but all drugs containing mycophenolate mofetil are to have a warning on the box that includes wording related to the increased risk of birth defects and loss of pregnancy.

The FDA approved mycophenolate mofetil in 1995 to prevent organ rejection in patients who have had kidney, heart or liver transplants. It is estimated that 459,000 people have taken this drug, which is marketed as CellCept by the pharmaceutical company Roche.

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: Drug Recalls

About E. Sizemore

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits

January 30, 2023 By The FDA

Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone

January 27, 2023 By The FDA

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

January 26, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard

January 25, 2023 By The CPSC

Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging

January 25, 2023 By The FDA

Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz

January 25, 2023 By The FDA

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

January 20, 2023 By The FDA

Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma

January 18, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

January 20, 2023 By The FDA

Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard; Sold Exclusively at Williams-Sonoma

January 18, 2023 By The CPSC

Sakar International Recalls Multi-Purpose Helmets Due to Risk of Head Injury

January 18, 2023 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits
  • Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone
  • Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED
  • Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
  • ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning
  • Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard
  • Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging
  • Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz
  • SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2023 Altrumedia · Terms of Service · Log in