FAQs About Phthalates & Pancreatic Enzymes
The Cystic Fibrosis Foundation wants to update you on information related to phthalates (pronounced “THA-lates”) and pancreatic enzymes. In 2008, researchers found higher levels of phthalates in the urine of children with cystic fibrosis (CF) who were taking pancreatic enzymes. At that time, it was learned that some of the enzymes on the market that people with CF take to digest food and absorb nutrients contain phthalates.
Since then, pancreatic enzyme products have been required to be reviewed and approved by the U.S. Food and Drug Administration (FDA). This has resulted in a change in the pancreatic enzymes on the market for people with CF. Some enzymes, however, continue to contain phthalates.
Below is information about phthalates and advice for people with CF taking pancreatic enzymes.
Phthalates (pronounced “THA-lates”) are a group of chemicals used in many products, including drugs, medical supplies, toys, vinyl flooring, wall covering, detergents, lubricating oils, food packaging, cosmetics and personal care products, such as nail polish, hair sprays, soaps and shampoos.
Phthalates help plastic be more flexible. In some medications, phthalates help slow the release of medicine so it works over a long period of time, making the medicine more effective.
Public awareness about phthalates in plastics, toys, foods and personal care products is rising. Virtually everyone has some level of phthalates in their bodies. However, there is concern that some, but not all, phthalates might be harmful to people’s health.
Some medications on the market, including some pancreatic enzymes, contain phthalates. Pancreatic enzymes help people with CF digest their food. Inside each enzyme capsule are many small “beads” that contain digestive enzymes. Each bead is covered with a special “enteric-coating.” This coating allows the beads to dissolve in the small intestine. The digestive enzymes are then released in the small intestine to help digest food. It is the “enteric-coating” on the beads that may contain phthalates. To learn more, please talk with your CF care center.
Talk with your CF care center about which pancreatic enzymes have phthalates. These ingredients also should be in the information you receive from the pharmacy about your enzymes. The phthalates that are found in some enzymes may be listed as hypromellose phthalate or hydroxypropyl methylcellulose phthalate.
To learn more, please talk with your CF care center and review the list of inactive ingredients found in pancreatic enzymes. DBP (dibutyl phthalate) and DEHP (di-2-ethylhexyl phthalate), which the FDA recommends not be used in drugs, are NOT in pancreatic enzymes.
It is not clear what effect, if any, phthalates have on humans. Little is known about how they may affect a person’s health. The Centers for Disease Control and Prevention has information about phthalates and human exposure.
Because the risk of malnutrition from not taking pancreatic enzymes is much greater than the potential risk related to phthalates, it is advised that people with CF continue taking their pancreatic enzymes as prescribed.
The CF Foundation’s Medical Advisory Council, together with the U.S. Food and Drug Administration (FDA), state that people with CF should continue to take their pancreatic enzymes as prescribed by their CF doctor. This is because the benefits of good nutrition outweigh any potential risk from phthalates.
Your current treatments are tailored for your health. These enzymes have been used in people with CF for decades with no known problems. Switching enzymes could have a negative impact on your or your child’s health.
It is important for you to talk to your CF care center before you or your child stops taking or changes any CF medications. People with CF who stop taking their pancreatic enzymes are at risk of malnutrition.
When people with CF do not take enzymes, they may have poor weight gain; foul-smelling, frequent, loose and/or large bowel movements; mucus or oil in the bowel movement; gas and/or stomach pain; and distention or bloating of the abdomen.
Your body will naturally remove phthalates through your urine. Research shows that phthalates do not build up in the body.
It is difficult to know what products contain phthalates. Manufacturers are not required to list the phthalate contents of products. However, due to public concerns on this issue and new laws, the phthalate content of products is becoming more available. Some companies have started to decrease the use of phthalates. More products say “phthalate-free” on the label.
In August 2008, the United States passed a law to ban some phthalates in children’s toys and childcare products, which is similar to a law in the European Union.
The CF Foundation learned about this issue in spring 2008 when a study that was done by Canadian researchers found more phthalates in the urine of children with CF taking pancreatic enzymes. Since then, we have been working to gather any available facts about phthalates and pancreatic enzymes and consult with CF medical experts.
The CF Foundation is establishing an international working group of CF experts to learn more about any potential risk of phthalates in pancreatic enzymes. We will keep the CF community updated as we learn more.
In an August 2008 joint telephone conference with the CF Foundation, the Canadian CF Foundation and Health Canada, the FDA reinforced that people with CF should continue taking their pancreatic enzymes because the benefits of good nutrition outweigh any potential risk from phthalates.
The FDA is aware of the use of phthalates in enzymes. Phthalates are included in its list of inactive ingredients for FDA-approved drugs. The FDA recently drafted a guidance document for industry recommending limiting the use of DBP and DEHP in oral medications. (NOTE: These phthalates are NOT in pancreatic enzymes.)
We are not sure what the FDA will do regarding this issue for the future. As we learn more, we will keep the CF community informed.
It is not known how the different phthalates affect people. Remember, information you find in print or on the Internet is dependent on the source. Here is a list of resources that you may find helpful: