What is Polysorbate allergy?

The short answer

Polysorbate is a polymer with structural similarity to polyethylene glycol (PEG). It is widely used in many pharmaceutical applications, cosmetics, and household products. Similar to PEG allergy, polysorbate allergy is reported following the administration of medications containing polysorbate. In this article, you can find all you need to know about polysorbate allergy.

Key Facts:

Polysorbates are polymers that are widely used in pharmaceutical preparations, cosmetics and beauty products, and many other daily used products.
There is a structural similarity between polysorbate and polyethylene glycol.
Several reports confirmed allergic reactions against polysorbate-containing products
The allergic reactions against polysorbate could be severe and life-threatening in some cases.
Polysorbate is one excipient in COVID-19 vaccines such as Novavax and J&J/Janssen vaccines and this could be the causative agent of allergic reactions reported against COVID-19 vaccines.
If you have a history of polysorbate or PEG allergy, you have to take care of the ingredients of what you eat or drink or the medications you take.

What is polysorbate:

Polysorbate is an excipient that is widely used in numerous pharmaceutical preparations.
It is a nonionic surfactant widely used in the pharmaceutical industry because of its emulsifying, dispersant, and stabilizing properties.
You may find its name written as:
- Polyoxyethylene-sorbitan-20-monooleate
- Polysorbate 80
- Tween 80
- Other polysorbates include polysorbates 20 and 60.
It is used in drug formulations and vaccines. Also, you can find it in food many cosmetics, and other household products
It is commonly used in creams, ointments, and lotions, and as an additive in tablets and multiple medical preparations (e.g., vitamin oils, vaccines, and anticancer agents) (Ref).

Polysorbate and Polyethylene glycol structural similarity

The chemical structure of polyethylene glycol and polysorbate are similar. Both have repeated units of ethylene oxide.

Structural similarity between polyethylene glycol and polysorbate 80

PEG and its structurally similar polysorbate compounds can be found in numerous products such as:
- Surgical gels
- PEGylated medications
- Household and industrial compounds
- Many Cosmetics and disinfectants
- Excipients in other medications both injectable and oral

However, it is common that PEGs and polysorbates are not consistently described in the ingredient list.

Polysorbate allergy

For a long time, there was a general assumption that PEG and PEG similar polymers as polysorbate are nonimmunogenic and could not induce the immune response.

However, during the last two decades, researchers confirmed the formation of antibodies against PEG and its structural similar compounds. These antibodies are called anti-PEG antibodies.

These antibodies are induced after patients are treated with PEG-containing therapeutics (PEGylated products). These antibodies are called treatment-induced anti-PEG antibodies.

In many cases, these antibodies are detected in healthy individuals who had never been treated with PEGylated products. In this case, scientists called these antibodies pre-existing or naturally occurring antibodies.

Scientists explain the presence of pre-existing anti-PEG antibodies in healthy individuals without previous treatment with PEGylated therapeutics for the following reasons:

PEG and polysorbate and their derivatives are commonly used in the manufacturing of several cosmetics and household products.
They are also used in many pharmaceutical preparations such as tablets, capsules, injectables formulations, and ophthalmic preparations.
The wide spread of these polymers in numerous daily used cosmetics and household products increases the chance that healthy individuals receive these polymers in different ways rather than PEGylated therapeutics.
Consequently, healthy individuals could produce anti-PEG antibodies during their normal life routine but actually, most of them don’t know about these antibodies.

The presence of anti-PEG antibodies represents a critical issue in developing hypersensitivity reactions when patients receive medications or vaccines containing excipients such as PEG or polysorbate or their derivatives.

When you take medications or vaccines containing PEG or polysorbates or their derivatives, the circulating anti-PEG antibodies bind selectively to the PEG molecule in the medication or vaccines. Consequently, this binding stimulates your immune response against the administered medication. The immune response reacts with these medications or vaccines as foreign bodies.

Your immune system releases histamines, interleukins, and other inflammatory mediators which produce symptoms of allergic or hypersensitivity reactions. The hypersensitivity and allergic reactions were severe and could be life-threatening in some cases.

Due to the structural similarity of polyethylene glycol (PEG) and polysorbate cross-reactivity between them was expected (Ref).

Polysorbate 80 is found as an excipient in the AstraZeneca COVID-19 vaccine. So during the COVID-19 pandemic, scientific research focused on polyethylene glycol (PEG) and polysorbate as these excipients are constituents in the first vaccines approved for COVID-19 and possible induction of allergic reactions to the vaccines.

According to the CDC Centers for Disease Control and Prevention (CDC), Polysorbate is an excipient used in the manufacturing of Novavax and J&J/Janssen vaccines. If you are allergic to polysorbate, you should avoid Novavax or J&J/Janssen COVID-19 vaccine

PEG and polysorbate are key ingredients in the COVID-19 vaccines as both Pfizer and Moderna’s shots include PEG, while Johnson & Johnson’s shot has polysorbate in it.

Several studies reported the development of severe immediate hypersensitivity reaction against polyethylene glycol (PEG or macrogol) and its structural similar polysorbate 80 (Ref)

There are thousands of medications and cosmetic products containing polyethylene glycol (PEG= macrogol) or structurally similar polysorbates

In 2002, A study reported the first case of allergic reaction to erythropoietin.

Erythropoietin is used for the treatment of symptomatic anemia resulting from chronic renal failure) due to polysorbate hypersensitivity.
The authors demonstrated that the patient had allergic reactions after forty minutes following the administration of Eprex (Eprex formulation contained recombinant human erythropoietin and polysorbate 80 as excipients (0.15 mg/mL).
Symptoms involved generalized pruritis, erythema, and orofacial angioedema.

A study reported a case of allergic hypersensitivity reaction in patients treated with received intramuscular administration of quadrivalent human papillomavirus vaccine (Gardasil).

Gardasil is a vaccine against human papillomavirus.
Allergic reactions were observed 1 h after the third dose of intramuscular administration of quadrivalent human papillomavirus vaccine (Gardasil).
The reported symptoms were: generalized urticaria, eyelid angioedema, rhino-conjunctivitis, dyspnoea, and wheezing
The case was treated with antihistamine, and corticosteroids with prompt relief of rhinitis and dyspnoea, while urticaria and angioedema lasted 24 h.
The intradermal test against Gardasil (which contains polysorbate 80) was positive

The National Institutes of Health DailyMed online resource through the National Library of Medicine is a useful resource for determining an individual product’s excipient content of macrogols such as PEGs and polysorbates

Symptoms of polysorbate allergy:

Symptoms of polysorbate allergy may vary individually depending on the severity of the reaction. the most common symptoms of polysorbate allergy include the following:

Itching and skin swelling
Rash
Neasuea
Vomiting
Diarrhea
Abdominal cramps
Shorting of breath
Wheezing
Anaphylaxis

How to avoid polysorbate allergy?

If you have a history of PEG or polysorbate allergy, you should avoid exposure to them as possible. you must read labels carefully and choose products free from both PEG and polysorbate. it is advised to have an epinephrine auto-injector with you at all times in case of a severe reaction (Ref).

You have to contact your health care provider in case of any symptoms of allergy.

What medications contain polysorbate 80?

Parenteral medications

Depo Medrol
Depo-Provera,
Docetaxel

Oral medications

Atorvastatin Lipitor
Sumatriptan
Valacyclovir, Valtrex
Etodolac
Fenoprofen
Flurbiprofen
Probenecid
Carvedilol, bisoprolol, Bystolic, and metoprolol succinate
Antibiotics such as Amoxicillin-clavulanate, cefuroxime, doxycycline, Levaquin
Antidepressant such as Amitriptyline, bupropion, citalopram, desipramine

Topical preparations

Epiduo, Finacea
Lidocaine
Terconazole, ketoconazole, terpenicol

Examples of FDA-approved PEGylated therapeutics (containing PEG)

PEG–asparaginase (Oncaspar®)
PEG–adenosine deaminase (Adagen®)
PEG–interferon α2a (Pegasys®)
PEG–interferon α2b (PEG–Intron®)
PEG–G-CSF (pegfilgrastim, Neulasta®)
PEG–growth hormone receptor antagonist (Pegvisomant, Somavert®)

FAQs:

1. Does polysorbate 80 cause allergic reactions?

Yes, reports showed that polysorbate 80 can cause severe nonimmunologic anaphylactoid reactions (Ref).

2. Can I recover from polysorbate 80 allergy?

The treatment of polysorbate allergy is symptomatic treatment but there is no cure for polysorbate allergy. Symptoms can be managed with appropriate medication and avoiding polysorbate exposures is the most important step.

3. What common foods have polysorbate 80?

You can find polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) in many foods such as ice milk, ice cream, frozen custard, sherberts, and frozen desserts. Also, it is used in pickles and canned vegetables.

4. Is polysorbate 80 in ice cream?

Yes, polysorbate is used in ice cream as an emulsifier to produce ice cream with a smooth body and texture and to increase its resistance against melting.

Typical concentrations of polysorbate 80 in ice cream are 0.02% to 0.04% of the total mix weight