Vioxxacute (withdrawn from market 30/09/2004)

How does it work?

This medicine contains the active ingredient rofecoxib, which is a type of medicine known as a non-steroidal anti-inflammatory drug (NSAID). NSAIDs work by blocking the action of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in producing prostaglandins, in response to injury or certain diseases. These prostaglandins cause pain, swelling and inflammation. Because NSAIDs block the production of these prostaglandins, they are effective at relieving pain and inflammation. Cyclo-oxygenase does not only produce prostaglandins that cause inflammation. It also produces prostaglandins that have useful roles in the body. There are two different forms of cyclo-oxygenase, COX-1 and COX-2. COX-2 is the form that (among other things) produces prostaglandins that cause inflammation. COX-1 does not produce inflammatory prostaglandins, but does produce others that have useful effects, including some that are involved in maintaining a healthy stomach and intestinal lining. Traditional NSAIDs, such as ibuprofen or diclofenac, block the action of both COX-1 and COX-2, and this is why they can sometimes cause side effects such as stomach irritation and peptic ulcers. Rofecoxib belongs to a new generation of NSAIDs that selectively block the action of COX-2. This means that it stops the production of inflammatory prostaglandins, without stopping the production of prostaglandins that protect the stomach and intestines. It therefore reduces pain and inflammation, but is less likely than traditional NSAIDs to cause side effects on the stomach and intestines.

What is it used for?

Abdominal pain associated with menstrual periods

Acute pain

Warning!

This medicine has been withdrawn from the market by the manufacturer as a result of new safety information uncovered during a clinical trial. The APPROVe study linked long-term rofecoxib use with an increased risk of heart attacks and stroke compared to placebo. All people taking this medicine should make an appointment with their GP to arrange an alternative prescription.

This medicine can sometimes cause liver problems. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms.

The use of any medicines known to inhibit COX-2 (eg rofecoxib) is not recommended in women attempting to conceive. This is because COX-2 plays a role in ovulation and implantation.

This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activites, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.

This medicine may hide fever, which is a sign of infection. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.

People with impaired kidney, liver or heart function should have their kidney function monitored while taking this medicine.

Use with caution in

Current or previous heart failure

Current or previous high blood pressure

Decreased kidney function

Dehydration

Elderly people

History of ulceration or bleeding in the stomach or intestines

Liver cirrhosis

Poor functioning of one chamber of the heart (left ventricular dysfunction)

Swelling due to excess fluid retention (oedema)

Not to be used in

Active peptic ulcer

Bleeding from the stomach or intestines

Breastfeeding

Children

Decreased liver function

Inflammatory bowel disease such as ulcerative colitis or Crohn's disease

Moderate to severely decreased kidney function

People who have developed asthma, nasal inflammation (rhinitis), nasal polyps, swelling of the face, lips and tongue (angioedema) or itchy rash (urticaria) following the use of aspirin or other NSAIDs

Severe heart failure

Third trimester of pregnancy

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used in the third trimester of pregnancy as it may be harmful to the foetus. It should only be used in the first or second trimesters if the potential benefit to the mother outweighs any potential risk to the foetus. Discuss this with your doctor. In addition, this medicine is not recommended for women trying to conceive.

It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Difficulty in sleeping (insomnia)

Depression

Blood disorders

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Weight gain

Indigestion (dyspepsia)

Retention of water in the body tissues (fluid retention)

Dizziness

Sensation of ringing, or other noise in the ears (tinnitus)

Difficulty in breathing (dyspnoea)

Sleepiness (somnolence)

High blood pressure (hypertension)

Increased sweating

Ulceration or bleeding of the stomach or intestines

Liver or kidney disorders

Rash or itching

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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