For Healthcare Providers

What are Gallstones?

Gallstones are small, hardened deposits that form in the gallbladder, an organ located beneath the right lobe of the liver. These stones can vary in size, from tiny grains to as large as golf balls, and are typically made of either cholesterol or bilirubin, a waste product from the breakdown of red blood cells. Gallstones develop in 10% to 15% of adults, often due to imbalances in the composition of bile, a digestive fluid produced by the liver and stored in the gallbladder. When substances in bile, like cholesterol or bilirubin, become too concentrated, they can solidify into crystals, which over time grow into gallstones.

Most gallstones are asymptomatic and may go unnoticed without treatment. However, they can become symptomatic, particularly in adults who are female, over 40 years old, obese, smoke, drink alcohol, or have certain underlying health conditions. Rapid weight loss can also increase the risk of gallstone formation. The presence of large or multiple stones also increases the likelihood of symptoms, which can occur if the stones block bile ducts or cause inflammation in the gallbladder. When stones do cause symptoms, it's often referred to as a "gallbladder attack" or "biliary colic."

Cholesterol gallstones, which are yellow and made mostly of undissolved cholesterol, and pigment gallstones, which are darker and form when there is too much bilirubin in the bile. Cholesterol stones are the most common type in Western countries, accounting for about 80% of gallstones.

Treatment for gallstones depends on the severity of symptoms and may range from watchful waiting for asymptomatic cases to surgical removal of the gallbladder (cholecystectomy) for severe or recurring cases. Lifestyle changes, such as maintaining a healthy weight and balanced diet, can help prevent the formation of gallstones in some individuals.

Risk Factors of Gallstones

Weight, Diet, and Lifestyle:

-Being overweight or obese significantly increases the risk of gallstones due to higher cholesterol levels in bile. A diet high in calories and low in fiber also contributes to this risk, as fiber helps lower cholesterol and promotes healthy bowel movements.

-Rapid weight loss, such as from very low-calorie diets or bariatric surgery, can increase the risk of gallstones because it causes the liver to secrete extra cholesterol into bile.

Age, Gender, and Genetics:

-The risk of gallstones increases with age, particularly after 40, due to changes in body composition and metabolism.

-Women are at higher risk of gallstones than men, especially during pregnancy or when taking oral contraceptives, due to elevated estrogen levels. Multiple pregnancies further increase this risk due to hormonal changes and weight gain.

Ethnic Background:

Certain ethnic groups, including Native Americans and Hispanics, have higher rates of gallstones, possibly due to genetic factors.

Medical Conditions:

Conditions like diabetes can increase the risk of gallstones. Diabetes is associated with higher cholesterol levels in bile and reduced gallbladder contractions.
Understand the Warning Signs

Symptoms of Gallstones

Understand the Warning Signs
Signs
Right Upper Abdominal Pain
Signs
  • Pain typically occurs after consuming greasy or spicy foods
  • Radiating pain may spread to the back, particularly to the right scapula or mid-back
  • Duration of pain can range from minutes to several hours
Nausea and Vomiting
Signs
  • Nausea often accompanies abdominal pain
  • Vomiting may occur as a result of severe pain or discomfort
  • Symptoms worsen after eating fatty meals
Epigastric Pain Radiating to Back
Signs
  • Pain originates in the upper abdomen and may spread to the middle or upper back
  • Pain intensifies with deep breathing or movement
  • Pain persists and does not resolve quickly
Jaundice (Yellowing of Skin and Eyes)
Signs
  • The skin and whites of the eyes may appear yellow
  • Urine may darken due to increased bilirubin levels
  • Itching of the skin (pruritus) can occur due to bile salts

If Left Untreated

Gallstones can lead to complications such as inflammation of the gallbladder (cholecystitis), bile duct obstruction, or, in severe cases, pancreatitis. Prompt medical evaluation and treatment are essential to prevent these complications.

Indications

Reltone (ursodiol capsules) is indicated for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, or idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Reltone beyond 24 months is not established.

Reltone is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Important Safety Information

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Reltone will not dissolve gallstones that are:

  • Made up of hardened (calcified) cholesterol • Visible with x-ray (radiopaque)
  • Made up of bile pigments and invisible with X-ray (radiolucent)

Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).

Do not use Reltone if you have an allergy to bile acids.

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.

Please click here for Prescribing Information of Reltone®

 

REFERENCES:

1. Reltone. Prescribing information. Intra-Sana
Laboratories LLC; 2021.

© 2024 Reltone. All Rights Reserved.

Important Safety Information

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Reltone will not dissolve gallstones that are:

  • Made up of hardened (calcified) cholesterol • Visible with x-ray (radiopaque)
  • Made up of bile pigments and invisible with X-ray (radiolucent)

Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the

gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).

Do not use Reltone if you have an allergy to bile acids.

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.