Exploring the Safety and Side Effects of Serrapeptase : What You Need to Know

Serrapeptase is a proteolytic enzyme obtained from the bacteria Serratia marcescens which is present in the intestinal region of silkworms. This proteolytic enzyme converts protein into its smaller sub-unit amino acids.^[6] It is also known as serratiopeptidase and it possesses anti-inflammatory, analgesic, atherosclerotic, and fibrinolytic properties. Due to this, it is used in a variety of conditions such as arthritis, trauma, surgery, dentistry, and carpal tunnel syndrome. It also prevents heart stroke in patients with a thrombus or clot inside the artery due to its fibrinolytic property that lyses the clot and improves blood circulation.^[7]

Serrapeptase was first studied In Japan for its anti-inflammatory properties, and it was first used parenterally but now its oral formulation is very common in use. It came on the market in the 1960s and showed very good results in the treatment of inflammation. It was marketed under the brand name Danzen. However, there are other various enzymatic preparations available to treat inflammation such as parenteral trypsin and chymotrypsin. But research conducted in Europe and Japan in the 1980s and 1990s concluded that serrapeptase was the best enzymatic preparation for the treatment of inflammation.^[6]

In the United States, serrapeptase is not used as a medication, instead its consumption is mostly as a dietary supplement. Since there are no proper regulations for dietary supplements, it is not approved by FDA, that’s why their side effects and drug interactions are not reported frequently. However, it is used all over the world, so people have started reporting some side effects and drug interactions of serratiopeptidase.^[3]

Minor Side Effects: Research to date shows that there are generally no such side effects associated with it and not everyone who takes this medication can experience the side effects. The minor side effects that are associated with it are joint pain, muscle soreness, nausea and stomach pain, skin reactions, cough, erythema, increased risk of pneumonia, and increased risk of some infections such as bladder infection. Typically, this type of side effect goes off or subsides once we stop using serratiopeptidase.^[4]

Severe Side Effects: The severe side effects are mostly rare and seen only in a small fraction of people. The severe side effect which is associated with it is Stevens-Johnson syndrome (it is a severe skin disease that is characterized by large blisters and even sometimes shedding skin). Also in some cases, people have developed pneumonitis (a lung inflammation) which is very rare but also very dangerous if remains untreated.^[5] Blood clotting abnormalities are also associated with the use of serratiopeptidase but chances are very few.

A report published in 2016 concluded that serratiopeptidase in some cases may cause an increase in the size of an abscess (a swelling on or inside the body, containing a thick yellow liquid which is known as pus), in part by breaking down masses of cells in neighbor tissue. However, this is only reported in one case and no other clinical significance was known till now.^[5]

There are no significant clinical studies available that determined its safety profile and evaluate its side effects. To prevent its side effects, one must have to take this preparation under the supervision of a medical practitioner to eliminate the possibility of drug interactions that can happen during medication intake.

As we know serratiopeptidase is used as a supplement and supplements can interact with other supplements, nutrients, and medications, many research has suggested that serrapeptase can show drug interaction with certain kinds of medications.^[6]

People who are on blood thinner medications such as aspirin, clopidogrel, and warfarin should avoid the use of serratiopeptidase because taking this with blood thinner medications can result in severe bleeding and bruising.

Other supplements such as garlic, fish oil, and turmeric may also potentiate the risk of bruising and bleeding.^[5] Therefore, the use of these supplements in conjugation with serratiopeptidase shall be avoided.

As we know any medication or supplement is never completely safe for anyone, however, Serrapeptase is considered safe in comparison. In some cases, serrapeptase may need to be avoided to prevent its side effects. However, in clinical trials that are usually short-term, it was determined to be fairly safe and involve only fewer side effects that involved complications for the patient’s primary medical condition. Clinical studies have not evaluated the safety of serrapeptase for long-term use, so people with long-term inflammatory disorders should avoid taking this as a medication or take it under the supervision of a medical practitioner.^[5]

Conditions in which patients need to take caution while using serratiopeptidase-

• Pregnant or breastfeeding women: It is safer for adults mostly in recommended doses but for children and pregnant women, its safety is not established till now. Therefore, it is better to avoid serrapeptase during pregnancy and breastfeeding.^[4]
• Individuals taking blood thinner medications: Patients who are already on blood thinners should avoid the use of serratiopeptidase because it can prevent the formation of blood clots due to its fibrinolytic effects and may produce hemorrhage in the rare case which is a life-threatening condition.^[4]
• Liver disease: If the patient is having a liver disease such as liver cirrhosis so in this condition it becomes difficult to process serratiopeptidase for the liver which may result in its accumulation in the body and produce side effects on the liver that make it worse even more.^[5]
• Patients with gastrointestinal ulcers: serrapeptase may irritate the stomach and GIT tract lining and may result in exacerbation of gastrointestinal ulcers, so patients with GIT ulcers should avoid its use.^[5]
• Allergies from silkworms: if a patient is having an allergy to silkworms, the patient is needed to avoid the use of serratiopeptidase.

Serratiopeptidase is a proteolytic enzyme that is used for a variety of conditions such as in case of thrombus formation inside the artery, treating scar tissue. It also shows anti-inflammatory and analgesic properties which are used to reduce inflammation as well as pain. There are some types of minor side effects linked with its use such as cough, joint pain, nausea, and stomach problem. As there is no clinical research that shows its safety profile for pregnant and breastfeeding mothers, so it is better to avoid this during pregnancy and breastfeeding. It is also contraindicated in patients with GIT ulcers or any liver disease, and it is recommended that it should be taken only under the supervision of a medical practitioner to avoid drug interaction and side effects associated with it.

References:

Also Read:

• What is Serrapeptase & How Does it Work, Know its Uses, Benefits, Side Effects?
• Serrapeptase : A Potential Enzyme-Based Treatment for Lyme Disease
• Serrapeptase : Mechanism of Action, Recommended Dosing, and Safety Profile