Parker Waichman LLP

Anti-rejection Drugs Cause Birth Defects

Cellcept and Myfortic Side Effects Health Canada, Canada’s health regulatory agency, warns that theorgan anti-rejection drugs CellCept (mycophenolate mofetil) and Myfortic (mycophenolate sodium) can cause miscarriage and congenital malformations following exposure during pregnancy. The agency warns about use of the drugs: during pregnancy due to their mutagenic (changing the DNA) and teratogenic (interfering with the […]

Anti-rejection Drugs

Cellcept and Myfortic Side Effects Health Canada, Canada’s health regulatory agency, warns that theorgan anti-rejection drugs CellCept (mycophenolate mofetil) and Myfortic (mycophenolate sodium) can cause miscarriage and congenital malformations following exposure during pregnancy.

The agency warns about use of the drugs:

  • during pregnancy due to their mutagenic (changing the DNA) and teratogenic (interfering with the development of the fetus) potential
  • by women of childbearing potential who are not using highly effective contraceptive methods
  • by women who are breastfeeding because of the potential for the drugs to cause genetic mutations

Congenital malformations-sometimes multiple-have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy.

The following malformations were most frequently reported:

  • facial malformations such as cleft lip, cleft palate, undersized jaw, increased distance between the eyes;
  • abnormalities of the ears and eyes;
  • malformations of the fingers;
  • cardiac abnormalities such as atrial and ventricular septal defects;
  • esophageal malformations;
  • nervous system malformations (such as spina bifida).

CellCept is given to prevent organ rejection in adult patients

CellCept is given to prevent organ rejection in adult patients who have received kidney, heart, or liver transplants. CellCept is also prescribed for pediatric patients (2 to 18 years of age) who have received kidney transplants.

Myfortic is prescribed for kidney transplant patients. These drugs are administered in combination with cyclosporine and corticosteroids.

Health Canada says that health care professionals should ensure that women and men taking mycophenolate drugs understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult a physician if there is a possibility of pregnancy.

Health Canada said a cumulative review of birth defects

Health Canada said a cumulative review of birth defects has confirmed that mycophenolate is a human teratogen (i.e., causes birth defects). The evidence showed an increased rate of congenital malformations and miscarriages associated with mycophenolate in comparison with other immunosuppressants.

Based on evidence from medical literature, Health Canada says, malformations occurred in 23 to 27 percent of live births in women exposed to mycophenolate mofetil during pregnancy, compared to 2 to 3 percent of live births in the overall population and approximately 4 to 5 percent in organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.

Cases of spontaneous abortions (miscarriage) have been reported in 45 to 49 percent of patients exposed to mycophenolate mofetil during pregnancy, compared to a reported rate between 12 and 33 percent in organ transplant patients treated with other immunosuppressants.

Health Canada says that women and men taking either of these CellCept

Health Canada says that women and men taking either of these CellCept or Myfortic should understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult a doctor if there is the possibility of a pregnancy.

Patients of reproductive potential should be made aware of the increased risk of pregnancy loss and congenital malformations and must be counseled about pregnancy prevention, and planning.

The agency advises women who could become pregnant to use two reliable forms of contraception simultaneously before they begin to take mycophenolate, during mycophenolate therapy, and for six weeks following discontinuation of therapy, unless abstinence is their method of contraception.

Need Legal Help Regarding Anti-rejection Drugs?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations.
For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529)

[sc name=”post-footers”]

Our lawyers for CellCept side effects are here to help you when you need it the most.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I am more than satisfied with the way my Attorney and the Staff at Parker and Waichman has been handling my case. They have kept me up to speed with process, and have explained in detail what is expected. I will refer this company to anyone who needs an Attorney who holds your best interest at heart.
Maria Warner-Dowrich
5 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value All of the above. I am very please with service that was rendered to me especially by Christina Morace who was on point with every questions that I asked her. She was very professional and above all very helpful to me. I will gladly recommend your company to anyone who needs a excellent Law Firm.
Bixley Simpson
2 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Parker Waichman did a great job on my claim — they were always very professional and they worked quickly and effectively. Stacie was great! Gina was as well.
Harris Paltrowitz
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038