Phthalates

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 like soaps and shampoos.

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Summary
  • Phthalates help plastic be more flexible.
  • In some medications, such as pancreatic enzymes, phthalates help slow the release of the medicine so it works over a long period of time, making the medicine more effective.

Why The Concern About Phthalates?

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 pancreatic enzymes contain phthalates. Pancreatic enzymes help people with cystic fibrosis 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. 

Some pancreatic enzymes contain the phthalate hypromellose. There is no medical evidence showing that hypromellose has a toxic effect on people with CF who take enzymes or in the children of women with CF who take enzymes during their pregnancy.

DBP (dibutyl phthalate) and DEHP (di-2-ethylhexyl phthalate), which the U.S. Food and Drug Administration (FDA) recommends not be used in drugs, are not in pancreatic enzymes.

Brand Pancreatic Enzyme Inactive Ingredient
Pancrelipase (Creon®) Hypromellose phthalate
Pancrelipase (Pancreaze®) No phthalates listed
Pancrelipase (Ultresa®) Hypromellose phthalate
Pancrelipase (Viokace®) No phthalates listed
Pancrelipase (Zenpep®) Hypromellose phthalate
Summary of inactive ingredients in pancreatic enzymes that are commonly used by people with CF, as of March 2012.

 

Viokace® is the only enzyme that comes in a tablet form and does not have an enteric coating. Because of this, it can be crushed and used in tube feedings.

Should I Be Concerned About Consuming Phthalates?

The Cystic Fibrosis Foundation's Medical Advisory Council and the FDA state that people with CF should continue to take their enzymes as prescribed by their CF doctor. This is because the benefits of good nutrition outweigh any potential risk from phthalates.

Your 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 team 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, or large bowel movements; mucus or oil in the bowel movement; gas or stomach pain; and distention or bloating of the abdomen.

Talk with your CF care team if you have questions about pancreatic enzymes and phthalates. The information you receive from the pharmacy about your enzymes should also contain this information.

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Reference to any specific product, process or service does not necessarily constitute or imply its endorsement, recommendation or favoring by the Cystic Fibrosis Foundation. The appearance of external hyperlinks does not constitute endorsement by the Cystic Fibrosis Foundation of the linked websites, or the information, products or services contained therein.

Information contained on this site does not cover all possible uses, actions, precautions, side effects or interactions. This site is not intended as a substitute for treatment advice from a medical professional. Consult your doctor before making any changes to your treatment.

FDA-approved drug information is available at www.dailymed.nlm.nih.gov/dailymed.

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