Cromolyn sodium is an FDA approved mast cell stabilizer that is prescribed to treat mastocytosis, allergic rhinitis, and mild to moderate bronchial asthma. It is sometimes prescribed off-label to manage food allergies. The only oral manufactured form available is a solution. For mastocytosis, cromolyn has been shown to improve diarrhea, flushing, headaches, vomiting, itching, abdominal pain, and nausea.

History of Cromolyn

Cromolyn was discovered by Roger Altounyan, a medical researcher who suffered from asthma, in 1965. Roger worked in a medical research department at a pharmaceutical company in the UK which was seeking a better bronchodilator by means of molecular modification. In 1961 his research project was canceled by the research director but he continued to test new compounds in secret. Uniquely, Roger tested most of the compounds on himself as an asthma sufferer. Between 1957 and 1965, Roger would induce around 1,000 asthma attacks in himself in order to test various treatments. Finally he discovered a compound that provided protection against asthma attacks. The compound was named disodium cromoglycate in the UK and cromolyn in the US. It was used in an inhaled form and quickly became a standard treatment for asthma throughout the world.

In the 1970s, other forms of cromolyn were developed. Topical solutions were developed for treating eye diseases and became widely used for allergic conjunctivitis. Next it was used for administration to the gastrointestinal tract and was studied for treating irritable bowel syndrome. The oral form of the drug was found to be useful for treating mastocytosis. A topical cream may be useful for treating itching related to mastocytosis and research is ongoing into other uses for the topical form.

Mastocytosis

Mastocytosis is a condition that is defined by the overproduction of mast cells. Mast cells are white blood cells that are a part of the immune system and their overproduction can cause problems throughout the body. Some types of mastocytosis may involve internal organs and others may be limited to the skin. The condition is characterized based on where the increase in mast cells is occurring. The cutaneous presentations of the condition tend to occur more frequently in children and systemic presentations are more common in adults, however all types can occur in patients of any age.

There are numerous possible symptoms of mastocytosis. The severity of symptoms can vary but are often similar to an allergic reaction. These are some possible symptoms as outlined by the American Academy of Allergy, Asthma & Immunology.

Symptoms of Mastocytosis

• Anaphylaxis
• Itching, flushing, hives, swelling
• Wheezing or shortness of breath
• Sinus congestion and pressure
• Throat swelling
• Palpitations, changes in blood pressure, dizziness, fainting
• Nausea, vomiting, abdominal pain, diarrhea
• Uterus cramps/bleeding
• Bone or muscle pain, osteopenia, osteoporosis
• Headache, brain fog, anxiety, short memory span, depression

Patients with this condition who are managing it will likely experience triggers for mast cell mediator release that causes a flare-up of these symptoms. These triggers can include high and low temperatures, stress, allergens, food, exercise, and more.

Treatments for Mastocytosis

Treatments for mastocytosis include H1-antagonists, H2-antagonists, NSAIDs, epinephrine, proton pump inhibitors, and more. The treatment depends on the unique presentation of mastocystosis in the patient and their symptoms. Some treatments can actually be used together. For example, cromolyn can be used with a non-sedating H1-antihistamine. Oral cromolyn is often considered most effective for systemic forms of the condition. For manifestations that present only in the skin, a topical formulation may be a first line treatment. Topical cromolyn can be used for any manifestation affecting only the skin.

Cromolyn Dosage

The dosages recommended for oral cromolyn vary. One recommended dosing schedule is to start patients at 100 mg daily and escalate in 8 weeks to 800 mg divided in 200 mg 4 times daily, on an empty stomach before meals and at bed time. Other dosing schedules may be required and can be determined based on the patient’s needs, their response to the dosing, and any side effects experienced. Side effects of oral cromolyn are rare and include headache and constipation.

Cromolyn has been shown to reduce the gastrointestinal symptoms of mastocytosis like diarrhea, abdominal pain, and nausea. This is attributable to stabilization of intestinal mast cells. When taken orally it can help with skin manifestations like itching and flushing. It has also been shown to restore cognitive abilities that may be affected by mastocytosis.

Compounded Cromolyn

Cromolyn is not commercially available in the form of a capsule or tablet. A compounding pharmacy can make capsules in any dosage required for oral use.

Articles

How we diagnose and treat systemic mastocytosis in adults – British Journal of Haematology

Current Options in the Treatment of Mast Cell Mediator-Related
Symptoms in Mastocytosis – Inflammation & Allergy

The discovery of cromolyn sodium and its effect on research and practice in allergy and immunology – The Journal of Allergy & Clinical Immunology