National Reye's Syndrome Foundation
Thanks to the FDA & our NRSF Team, Baby Aspirin Does Not Exist Anymore!
Fall 2011 Newsletter -- On April 28, 2011, the National Reye's Syndrome Foundation, spearheaded by Aspirin Committee Chairperson, Marianne Piemonte, sat down with a large group of doctors at the FDA. Representing the NRSF was John Freudenberger, NRSF President, and Co-Founder, Terri Freudenberger, Co-Founder, Dr. Karen Starko, MD, Epidemiologist, the Honorable J. Joseph Curran, Former Attorney General of the State of Maryland. Marianne Piemonte, although unable to attend sent letters and documentation.
Present from the FDA Ralph Tyler, Chief Counsel, Seth Ray, Associate Deputy Chief Counsel for Drugs & Biologics, Dr. Charles Ganley, Director, Office of Drug Evaluation IV (ODE IV) Dr. Shaw Chen, Deputy Director, Office of Drug Evaluation IV, Mike Levy, Director, Division of New Drugs and Labeling Compliance, Dr. Scott Furness, Director, Division of Nonprescription Regulation Development, Dr. Andrea Leonard-Segal, Director, Division of Nonprescription Clinical Evaluation, Dr. Joel Schiffenbauer, Deputy Division Director, Division of Nonprescription Clinical Evaluation.
Opening statements on the meeting purpose and objective was given by J. Joseph Curran, and then an introduction to the National Reye's Syndrome Foundation and its Objective and Formation was presented by John E. Freudenberger. A medical history concerning aspirin was presented by Dr. Karen Starko, and then the Bayer "Baby" Aspirin Issue was presented through letters and documentation from NRSF Aspirin Committee Chairperson, Marianne Piemonte. Terri J. Freudenberger spoke to the issue, showing aspirin packaging exhibits and entering a number of letters from Reye's Syndrome Parents, Survivors, Medical Doctors, and School Nurses into the discussion. In summation, J. Joseph Curran asked the FDA to speak with Bayer Consumer Health Care about its utilization of the word "Baby" in Low Dose Aspirin labeling and marketing, and emphasized the issue of Consumer Label Misunderstanding.
A very good discussion ensued and we felt the FDA understood our concerns. June 30, 2011, the NRSF phone rang and it was Dr. M. Scott Furness with the FDA. He informed the NRSF office that he indeed had spoken with Bayer Consumer Health Care, and they agreed that their labeling might be misunderstood by the consumer. Bayer agreed to immediately stop using the term 'baby aspirin' in referring to Low-Dose aspirin, and assured us that by mid year 2012 all packaging would no longer carry the word 'baby' on it!
Both the NRSF and the FDA were thrilled! "This is a wonderful example of how concerned citizens can work hand in hand with a government entity like the FDA to improve the safety of Over-The-Counter products used by the American people every day," states M. Scott Furness, Ph.D., Division of Nonprescription Regulation Development (DNRD) Director.
Aspirin ingestion is linked to development of Reye's Syndrome, which kills by attacking the body's organs, most notably the liver and brain, and affects primarily children and adolescents. FDA mandated in 1986 that all aspirin products carry a Reye's Syndrome warning on back-panel packaging stating children and teens should never ingest aspirin for chickenpox or flu symptoms prior to physician consultation.
While Bayer for years maintained use of the word "baby" was meant to denote the product as a "smaller version" of its adult 325mg-aspirin product, NRSF learned that consumers, especially new parents, often misinterpret the term to mean it's safe for children and infants.
"We were receiving calls almost daily from panicked parents who thought they might have just killed their child because they hadn't read the back-of-package warning label," NRSF Co-founder Terri Freudenberger says. "They only read the front label where it shows the word 'baby' and they assume it is safe to give their child. We had to do something to clarify the use of this medication to the consumer, so we took our concerns directly to the FDA."
Effective June 30, 2011, Bayer stated; "that Bayer HealthCare, Consumer Care was immediately dropping the word "baby" from digital and print advertising and marketing, and that Bayer HealthCare, Consumer Care would discontinue printing packaging using the word "baby" over the coming months with the goal of a full transition by mid-2012." This will include television, Internet, and radio marketing and advertising, also.
John Freudenberger, President of the NRSF, states, " Bayer HealthCare, Consumer Care's decision supports the Foundation's 37 year mission to eradicate the incidence of Reye's Syndrome in children, and allows us to get closer to achieving that goal. We thank them for doing the right thing on behalf of children everywhere."
Our heart felt appreciation goes out to Mr. Ralph Tyler, and to Dr. M. Scott Furness, Anuj A. Shah, Seth Ray, Dr. Andrea Leonard-Segal, Dr. Joel Schiffenbauer, Dr. Charles Ganley, Dr. Shaw Chen, Mike Levy, and the rest of the FDA team for meeting with us, and for their support in pursuing our request to contact Bayer Consumer Health Care in regards to the "Baby" aspirin issue.
Not present at this historic FDA meeting, but of invaluable assistance were NRSF members; Lorraine and William Fitzsimmons, Dr. Larry Schonberg from CDC, Lois Hall, and many School Nurses, Doctors, Parents, and RS Survivors who sent in comments and information to support our position on the issue.
July 5, 2011 - National Reye's Syndrome Foundation
Bayer Drops "Baby" Aspirin
Today, in a phone call from the FDA, the National Reye's Syndrome Foundation learned that Bayer Consumer Health Care has agreed to remove the word 'baby' from all of its aspirin packaging and marketing materials. The 81mg aspirin product will now be known as Bayer 81mg Low Dose Aspirin.
The National Reye's Syndrome Foundation (NRSF) had met with the FDA on April 28, 2011 in Silver Springs Maryland, to voice its concerns about consumer misunderstanding of the use of the product, given the front panel stated low dose "baby" aspirin. Although Bayer Consumer Health Care maintains that their use of the word "baby" was meant to describe the product "as a smaller version of their adult 325mg aspirin" product, the National Reye's Syndrome Foundation found that consumers, especially new parents, were thinking the product was safe for children and infants. "We were receiving calls just about every day from panicked parents who thought they had just killed their child because they had not read the warning label on the back of the package. They only read the front label where it showed the word 'baby' and assumed it was safe to give their child", states Terri Freudenberger, Co-Founder of the Foundation. "We had to do something to clarify the use of this medication to the consumer so we took our concerns to the FDA."
In 1984 the FDA mandated that all aspirin products display a Reye's Syndrome Warning label on the back panel of the product after it was discovered by a team of CDC epidemiologists lead by Dr. Karen Starko, that aspirin (salicylate) could trigger Reye's Syndrome. Dr. Starko participated with the NRSF in the meeting with the FDA in April and had this to say about Bayer's decision, "This is an important step in aligning marketing and packaging information with proper use. Kudos to the National Reye's Syndrome Foundation for spearheading the conversation in this issue on behalf of children, and to the FDA for a prompt response."
Marianne Piemonte, Aspirin Committee Chairperson at the National Reye's Syndrome Foundation states, "We really have to acknowledge Bayer Consumer Health Care for their commitment to the health and well-being of children, and for their desire to properly educate consumers. The term "baby" aspirin is a misnomer. Forty years after the death of our sweet little girl I can now celebrate her short life, confident that no other parent will ever again innocently give their baby or toddler aspirin believing, erroneously, that it is safe medicine.
Former Maryland Attorney General, Joe Curran, who assisted in setting up the meeting between the NRSF and the FDA stated, "Thanks to Bayer for the agreement to remove "Baby" from bottles and marketing material, and a very special thanks to the leadership of John Freudenberger for the Reye's Syndrome Foundation programs that have made parents aware of this disease, and of course, a heartfelt thanks to the FDA for listening to our concerns."
John Freudenberger, President of the National Reye's Syndrome Foundation, states, "Bayer Consumer Health Care's decision supports the Foundation's 37 year mission to eradicate the incidence of Reye's Syndrome in children, and allows us to get closer to achieving that goal. We thank them for doing the right thing on behalf of children everywhere."
When Reye's Syndrome develops, it typically occurs when a person is beginning to recover from a viral illness like flu or chicken pox. It is a disease that affects all organs of the body; most lethally the liver and the brain, and mostly in children. Epidemiological research has shown a connection between Reye's Syndrome and aspirin (salicylate). More can be learned about Reye's Syndrome at www.ReyesSyndrome.Org.
=> UK Government bans aspirin for under-16s
=> In 1918 Pandemic, Another Possible Killer: Aspirin