FDA Changes Regarding Patient Education and Mycophenolate-Containing Products (CellCept©, Generic Mycophenolate Mofetil, Myfortic©)
The Penn Lung Transplant program would like to share an update about an education program that was recently implemented by the US Food and Drug Administration (FDA) to help ensure all female patients of child-bearing age are informed and educated about risks associated with products containing the immunosuppressant Mycophenolate.
Mycophenolate products include CellCept and its generics, mycophenolate mofetil and Myfortic.
History
It has been known since 2007 that these medications can cause birth defects and loss of pregnancy. In addition, these products also decrease the effectiveness of hormonal contraceptives including the Pill, the patch, the ring and injections. In 2007, when the FDA made these risks known to the medical community, the Penn Lung Transplant team incorporated this product information into standard education protocols for affected patients.
If you are a female lung transplant recipient, your lung transplant coordinator reviewed all of this information with you in detail before you began taking the medication. Please note, there is no change in the known risks associated with these medications.
New FDA Education Program
While there are no new, known, risks associated with mycophenolate or mycophenolate-containing products, the FDA recently implemented a new mandatory patient education program that requires all female patients of child-bearing years to sign a document acknowledging that they have been informed of, and fully understand, the risks the drug present.
What this means for you
If you are a female lung transplant recipient of child bearing years, at your clinic visit:
This information will again be reviewed;
You will have an opportunity to discuss questions or concerns with the team; and, you will be asked to sign an acknowledgement form that you have received the information and understand the risks associated with mycophenolate and mycophenolate-containing products.
For those awaiting lung transplants, this acknowledgement form has been incorporated into the post-lung transplant education materials.
It is important for any female patient taking a mycophenolate product, who is able to become pregnant, to be aware of appropriate methods for contraception.
If you are thinking of becoming pregnant, or you do get pregnant, it is critical that you to talk to your transplant physician to make sure your medication regimen can be safely modified.
Additional information has been available by the FDA though an online booklet entitled Mycophenolate REMS: Overview for Patients & Your Birth Control Options.
Please don’t hesitate to contact your transplant coordinator if you have any questions about the mycophenolate education program or risks associated with mycophenolate and mycophenolate-containing products.