Ivermectin

IMPORTANT NOTICE:

[Posted 04/10/2020]

AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary

ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.

BACKGROUND: The FDA's Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, "The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro" documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish.

Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species.

RECOMMENDATION:

• People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people.
• People should not take any form of ivermectin unless it has been prescribed by a licensed health care provider and is obtained through a legitimate source.
• Ivermectin is an important part of a parasite control program for certain species and should only be given to animals for approved uses or as prescribed by a veterinarian in compliance with the requirements for extra-label drug use.
• If you are having difficulty locating a particular ivermectin product for your animal(s), FDA recommends that you consult with your veterinarian.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

WHY is this medicine prescribed?

Ivermectin is used to treat strongyloidiasis (threadworm; infection with a type of roundworm that enters the body through the skin, moves through the airways and lives in the intestines). Ivermectin is also used to control onchocerciasis (river blindness; infection with a type of roundworm that may cause rash, bumps under the skin, and vision problems including vision loss or blindness). Ivermectin is in a class of medications called anthelmintics. It treats strongyloidosis by killing the worms in the intestines. It treats onchocerciasis by killing the developing worms. Ivermectin does not kill the adult worms that cause onchocerciasis and therefore it will not cure this type of infection.

Are there OTHER USES for this medicine?

Ivermectin is also sometimes used to treat certain other roundworm infections, head or pubic lice infestation, and scabies (itchy skin condition caused by infestation with small mites that live under the skin). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ivermectin comes as a tablet to take by mouth. It is usually taken as a single dose on an empty stomach with water. If you are taking ivermectin to treat onchocerciasis, additional doses 3, 6, or 12 months later may be necessary to control your infection. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ivermectin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking ivermectin to treat strongyloidiasis, you will need to have a stool exam at least three times during the first 3 months after your treatment to see if your infection has cleared. If your infection has not cleared, your doctor will probably prescribe additional doses of ivermectin.

What SPECIAL PRECAUTIONS should I follow?

Before taking ivermectin,

• tell your doctor and pharmacist if you are allergic to ivermectin, any other medications, or any of the ingredients in ivermectin tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while you are taking ivermectin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had conditions that affect your immune system, such as human immunodeficiency virus (HIV), or any other medical condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant during your treatment with ivermectin, call your doctor.

• if you are taking ivermectin for onchocerciasis, you should know that you may experience dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

  if you are taking ivermectin for strongyloidiasis and have had loiasis (Loa loa infection with a type of worm that causes skin and eye problems) or if you have ever lived in or traveled to areas of West or Central Africa where loiasis is common, you should know that you may have a serious reaction. Call your doctor immediately if you experience blurred vision, head or neck pain, seizures or difficulty walking or standing.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Ivermectin is usually taken as a single dose. Tell your doctor if you do not take your medication.

What SIDE EFFECTS can this medicine cause?

Ivermectin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• loss of appetite
• nausea
• vomiting
• stomach pain or bloating
• diarrhea
• constipation
• weakness
• uncontrollable shaking of a part of the body
• chest discomfort

If you are taking ivermectin to treat onchocerciasis, you may also experience the following side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling of the eyes, face, arms, hands, feet, ankles, or lower legs
• joint pain and swelling
• painful and swollen glands of the neck, armpit or groin
• rapid heartbeat
• eye pain, redness, or tearing
• swelling of the eye or eyelids
• abnormal sensation in the eyes
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blistering or peeling skin
• rash
• hives
• itching
• sleepiness. confusion, disorientation, or coma (loss of consciousness for a period of time)

Ivermectin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• rash
• hives
• seizure
• headache
• tingling of hands or feet
• weakness
• loss of coordination
• stomach pain
• nausea
• vomiting
• diarrhea
• dizziness
• shortness of breath
• swelling of the face, arms, hands, feet, ankles, or lower legs

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ivermectin.

Do not let anyone else take your medication. Your prescription is probably not refillable.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.