FDA Approves Pertzye – Know the Side Effects

The U.S. Food and Drug Administration (FDA) has approved Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.

Pertzye is a unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres. The Pertzye formulation was previously marketed by DCI for over a decade under the trade name Pancrecarb MS-16.

Pertzye may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you.

Call your doctor right away if you have any unusual or severe:

  • stomach area (abdominal) pain
  • bloating
  • trouble passing stool (having bowel movements)
  • nausea, vomiting, or diarrhea

Take Pertzye exactly as prescribed by your doctor. Do not take more or less Pertzye than directed by your doctor.

Pertzye may cause serious side effects, including:

  • See Important information about Pertzye
  • Irritation of the inside of your mouth. This can happen if Pertzye is not swallowed completely.
  • Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
  • Allergic reactions, including trouble breathing, skin rash, itching, or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common side effects of Pertzye include:

  • diarrhea
  • upset stomach (indigestion)
  • cough

Other possible side effects:

Pertzye and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Pertzye. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.