Is Pfizer Crazy or What?

Is Pfizer Crazy or What? (What will be the fate of Celebrex?)
Survey began 18 October 2004.
Survey ended 23 November 2004.

BACKGROUND
Vioxx, a Merck COX-2 inhibitor, was recently pulled from the market after one of MerckÂ’s own studies showed an increased risk of strokes and heart attacks seen in patients after three years on the drug (see Vioxx Withdrawal and the "Me-Too Drug Domino Effect"). On October 15, 2004, Pfizer announced that one of its COX-2 inhibitors -- Bextra -- was also associated with an increase in heart attacks and strokes. Almost simultaneously with the Bextra announcement, Pfizer—according to the Wall Street Journal—plans to sponsor a clinical trial to test Celebrex -- another COX-2 inhibitor -- to see if it is able to prevent heart attacks and strokes in patients with serious cardiovascular disease.
Is this a gamble for Pfizer or it's only option to protect the market for Celebrex?
What will be the fate of Celebrex?
Survey Results:
  • Editorial Summary, which presents highlights of selected results (PDF format).
  • Pharma Marketing News Summary, which presents more detailed results plus data on physician prescribing of COX-2 inhibitors before and after the Vioxx withdrawl. (REPRINT available).
  • Interactive Summary of ALL results (de-identified, excludes open-ended responses and comments that may identify the respondent). Allows you to use filters to examine results from different subsets of respondents (e.g., pharma company employees vs. non-pharma people, etc.)
Celebrex ®
(celecoxib)

100mg and 200mg capsules
PRESCRIPITON MEDICINE
Consumer Medicine Information
The following answers some common questions about Celebrex. It does not contain all the available information. 
It does not take the place of talking to your doctor or pharmacist. 
All medicines have risks and benefits. Your doctor will weigh the risks of you takingCelebrex against the benefits it is expected to have for you. 
If you have any concerns about taking Celebrex , ask your doctor or pharmacist.

What Celebrex is used for: 
Celebrex is used to treat joint pain, tenderness, swelling and stiffness:
  • in osteoarthritis
  • and in rheumatoid arthritis.
Celebrex is also used to relieve short-term pain, in cases such as:
  • menstrual cramps (period pain)
  • following surgery
  • dental pain.
Celebrex belongs to a group of medicines called Coxibs. Celebrex is used to relieve the pain and inflammation associated with arthritis.
Although Celebrex can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed Celebrex for another purpose.
Ask your doctor if you have any questions about why Celebrex has been prescribed for you. 
Celebrex has not been studied in children or adolescents under 18 years of age.

This medicine is only available with a doctor's prescription.
Do not take Celebrex if:
1. you have an allergy to:
  • Celebrex
  • any of the ingredients listed at the end of this leaflet
  • sulphonamides, a group of medicines which include, for example, certain antibiotics (If you are not sure if you are taking one of these medicines ask your Pharmacist).
Symptoms of an allergic reaction to these medicines may include:
  • asthma, wheezing or shortness of breath
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • hives, itching or skin rash
  • fainting
If you are allergic to sulphonamides or any of the capsule ingredients and take Celebrex , these symptoms may be severe.
Ask your doctor or pharmacist if any of this applies to you.

2. you have had an attack of asthma, hives, itching, skin rash or a runny nose after taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to treat pain and inflammation) 
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or an NSAID. 
If you are allergic to aspirin or NSAIDs and use Celebrex , these symptoms may be severe.

3. you are already taking an NSAID .
4. the expiry date printed on the packaging has passed, even though the capsules may look alright. If you take this medicine after the expiry date has passed, it may not work as well.
5.the packaging is torn or shows signs of tampering
If you are not sure if you should be taking Celebrex , talk to your doctor.
You must tell your doctor if:
1. you have any allergies to
  • any other medicines
  • any other substances such as foods, dyes or preservatives
2. you are pregnant or intend to become pregnant. There is no information on the use ofCelebrex during pregnancy. Celebrex may affect your developing baby if taken in the last 3 months of pregnancy. Celebrex use is not recommended in pregnancy unless your doctor considers it essential. Discuss this with your doctor.
3. you are breast-feeding or intend to breast-feed Since it is not known whetherCelebrex passes into breast milk or whether your baby might be affected, Celebrexshould not be used during breastfeeding.
4. you have any other health problems including
  • liver or kidney problems
  • asthma, hives, itching, skin rash or a runny nose
  • high blood pressure, heart failure or fluid retention
  • peptic ulcer (ie stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
  • vomiting blood or material that looks like coffee grounds
  • bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea.
5. you drink large amounts of alcohol
6. you are a smoker
If you have not told your doctor or pharmacist about these things, tell them before you start taking Celebrex .
Taking other medicines
Tell your doctor or your pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Celebrex may interfere with each other. These include
  • certain medicines used to treat high blood pressure called ACE inhibitors
  • diuretics or water tablets
  • fluconazole, an antifungal agent
  • lithium, a medicine used to treat some type of depression
  • warfarin, a medicine used to stop blood clots.
  • certain medicines used to treat pain and inflammation called non steroidal anti-inflammatories (NSAIDs) or (cortico) steroids.
Your doctor may need to adjust the dosage of these medicines, or provide additional advice if you are also taking Celebrex.
How to take Celebrex 
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information here.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take
Osteoarthritis

  • 200 mg once daily or 100 mg twice daily, or as directed by your doctor.
Rheumatoid arthritis
  • 100 mg twice daily or 200 mg twice daily.
Management of short-term pain and menstrual cramps (period pain):
  • 400 mg on the first day and 200 mg once daily on following days.
How to take it
Swallow the capsules whole with a glass of fluid. Celebrex can be taken with or without food.

How long to take it
Depending on your condition, you may need Celebrex for a few weeks or longer periods.Celebrex will not cure your condition but should help control arthritic pain, swelling and stiffness.
Keep taking Celebrex for as long as your doctor advises.
If you forget to use it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking your capsules as you would normally.
Do not take a double dose to make up for the dose you missed.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 03 4747000) for advice, or go to Casualty at your nearest hospital if you think you or anyone else may have taken too much Celebrex . Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much Celebrex , you may feel tired, drowsy, sick, vomit, and have stomach pain. You may also have difficulty breathing and feel faint.
Things you must do
If you become pregnant while taking Celebrex , tell your doctor immediately. If you are about to start any new medicines, tell your doctor and pharmacist that you are takingCelebrex . Tell all doctors, dentists and pharmacists who are treating you that you are taking Celebrex Things you must not do Do not give Celebrex to anyone else, even if they have the same symptoms or condition as you. Do not use Celebrex to treat any other complaints unless your doctor tells you to.

Side effects
Check with your doctor as soon as possible if you have any problems while takingCelebrex , even if you do not think the problems are connected with the medicine or are not listed in this information. Like other medicines, Celebrex can cause some side effects. If they occur, most are likely to be minor and temporary.

Ask your doctor or pharmacist any questions you may have.
Tell your doctor if you notice any of the following:
  • stomach pain, diarrhoea, indigestion, wind
  • swollen hands, ankles and feet
  • dizziness
  • sore throat, runny nose, sinusitis, upper respiratory tract infection
  • rash
Tell your doctor immediately if you notice any of the following:
  • collapse or fainting, shortness of breath or tiredness, irregular heart beat, chest pain, swollen or sore leg veins
  • severe stomach or throat pain, vomiting blood or black sticky bowel motions
  • bleeding or bruising more than usual, reddish or purple blotches under the skin
  • yellowing of the skin or eyes, called jaundice
  • signs of anaemia such as tiredness, being short of breath and looking pale
Not all of these side effects have been reported with Celebrex but have been seen with similar medicines.
Other side effects not listed above may occur in some people. .
Do not be alarmed by this list of possible side effects. You may not get any of them. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Storage 
Keep your capsules where young children cannot reach them. 
A locked cupboard at least 1½ metres above the ground is a good place to store medicines. 
Keep Celebrex in a cool, dry place where the temperature stays at or below 25°C. Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it in the car or on window sills. 
Heat and dampness can destroy some medicines. 
Keep your capsules in their blister pack until it is time to take them. 
If you take the capsules out of their container they may not keep well. 

Disposal 
If your doctor tells you to stop taking Celebrex , or the capsules have passed their expiry date, ask your pharmacist what to do with any left over.

Product description
  • Celebrex 100mg - opaque, white capsules with a blue band marked 7767 and 100
  • The 100mg capsules come in blister packs of 60.
  • Celebrex 200mg - opaque, white capsules with a gold band marked 7767 and 200
  • The 200mg capsules come in blister packs of 30.
Active ingredient The active ingredient in Celebrex is celecoxib.
  • Celebrex 100mg - 100mg celecoxib/capsule
  • Celebrex 200mg - 200mg celecoxib/capsule
Other ingredients
  • D-lactose
  • sodium lauryl sulphate
  • povidone
  • croscarmellose sodium
  • magnesium stearate
  • gelatin
  • titanium dioxide
  • iron oxide yellow CI 77492 /200mg capsule
  • indigo carmine CI 73015 /100mg capsule


Celebrex does not contain sucrose, gluten, tartrazine or other azo dyes.

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