Drugs Q & A

Why Is Arcoxia (Etoricoxib) Banned In The U.S?

What is Arcoxia?

Arcoxia is a brand of Etoricoxib used for the management of acute and chronic signs and symptoms of osteoarthritis and rheumatoid arthritis, the management of ankylosing spondylitis, relief of chronic musculoskeletal pain, relief of acute pain, treatment of acute gouty arthritis

Your doctor will prescribe Arcoxia for you only after you have used other medicines for your condition and they have not been suitable for you.

Why Is Arcoxia (Etoricoxib) Banned In The U.S.?

According to a news report, Arcoxia is banned in the United States because a panel of federal drug advisers at the Food and Drugs Administration voted 20 to 1 in 2007 to reject an application by Merck to register Arcoxia as a medication in the U.S due to concerns that the drug could cause as many as 30,000 heart attacks annually if widely used.

Arcoxia is a sister to Vioxx, which Merck withdrew in 2004 after a study showed that it also increased the risks of heart attacks and strokes. Merck sells Arcoxia in 63 countries, and the company underwrote an extensive safety testing program that involved 34,000 arthritis patients.

The studies showed that Arcoxia caused nearly three times as many heart attacks, strokes, and deaths as naproxen, a popular pain pill sold as Aleve, but was no more effective in curing pain. Patients taking Arcoxia suffered worrisome increases in blood pressure as a result Arcoxia has not been approved by the FDA for the U.S. market.

What are the possible side effects of Arcoxia I should know?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Arcoxia.

Arcoxia helps most people with osteoarthritis, rheumatoid arthritis, menstrual pain, gout, or other types of pain, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice or have any of the following and they worry you:

  • feeling sick (nausea), vomiting
  • heartburn, indigestion, uncomfortable feeling or pain in the stomach
  • diarrhoea
  • swelling of the legs, ankles or feet
  • high blood pressure
  • dizziness
  • headache

Additionally, the following have been reported:

  • allergic reactions including rash, itching and hives
  • severe skin reactions, which may occur without warning
  • taste alteration
  • wheezing
  • insomnia
  • anxiety
  • drowsiness
  • mouth ulcers
  • diarrhoea
  • severe increase in blood pressure
  • confusion
  • hallucinations
  • platelets decreased

These are usually the mild adverse effects of Arcoxia.

If any of the following happen, stop taking Arcoxia and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing (hypersensitivity reactions, anaphylactic/anaphylactoid reactions including shock)
  • abnormal rhythm of the heart (atrial fibrillation)
  • heart failure
  • palpitations
  • serious kidney problems
  • serious liver problems
  • stomach pain
  • stomach ulcers that may become serious and may bleed, and may occur at any time during use and without warning

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

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