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NSAID's WARNING







.
NSAID's WARNINGS.

Important Information You Need To Be Aware Of Prior to using NSAId's such as Advil and Motrin:

Subject matter Quick Links for this page…

1) Ibuprofen in heart attack scare warnings
2) FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
3) FDA Announces Changes for All NSAIDs; Bextra Withdrawn From Market


Medical authorities continually caution physicians and patients with regards to the use of non-steroidal anti-inflammatory pain relievers known as NSAIDs.

These pain relievers such as aspirin, ibuprofen, naproxen sodium, etc... are believed to be responsible for more than 76,000 hospitalizations each year due to gastrointestinal bleeding. An estimated 41,000 hospitalizations and 3,300 deaths involving the elderly are attributed annually to NSAIDs.


Ibuprofen in heart attack scare warnings

Published: 24/10/2006

Painkillers 'can increase the risk of heart attacks' Doctors are being warned today that high doses of common painkillers such as ibuprofen can increase the risk of heart attacks.

The Commission on Human Medicines (CHM) has written to healthcare professionals informing them that non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of heart attacks or stroke when used in high doses over the long term.

It comes after the European Medicines Agency (EMEA) ruled that the benefits of non-selective NSAIDs still outweigh any increased risks.

Today, its Committee for Medicinal Products for Human Use (CHMP), said it "cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment".

Nevertheless, it ruled that the "overall benefit-risk balance for non-selective NSAIDs remains favourable" when the patient's history was taken into account and packet instructions were followed.

Millions of people take the drugs for a range of conditions, including long-term osteoarthritis and rheumatoid arthritis. The non-selective NSAIDs examined in the review were diclofenac, etodolac, ibuprofen, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen, nimesulide and piroxicam (which is still being assessed).

The study related to high-dose NSAIDs prescribed by doctors for the long-term treatment of conditions.

Such doses are around double that in over-the-counter (OTC) tablets, which are often used for short-term ailments. The EMEA said: "The Committee confirmed its previous advice for doctors and patients to continue to use the lowest effective dose for the shortest possible duration to control symptoms. "As for all medicinal products marketed in the European Union, non-selective NSAIDs are being continuously monitored, and appropriate actions will be taken if any concerns arise." Today, the CHM said the findings did not call into question the value of the medicines, "but will enable updated information to be provided that will help healthcare professionals and patients to make informed choices about their medicines and treatment".

The Medicines and Healthcare products Regulatory Agency (MHRA) will now ask manufacturers to update their product information for NSAIDs based on the recommendations from the CHM and (CHMP).

Vioxx, which is part of a group of anti-inflammatories known as COX-2 inhibitors, was banned in 2004 after it was shown that patients on the drug were more than twice as likely to have heart attacks as those not taking it.

In June, research published in the British Medical Journal (BMJ) showed that ibuprofen and diclofenac increased the risk of heart attacks when taken in high doses.

The study showed that, as expected, COX-2 inhibitors doubled the risk of an attack, as did NSAIDs.

When all "vascular events" - heart attacks, stroke, or vascular disease - were taken together, the risks increased by 40% on the drugs, said the researchers from the University of Oxford and the University of Rome.

They found there were three more heart attacks per 1,000 people every year in those who did not already have heart disease but who were taking COX-2 inhibitors or NSAIDs.

Dr Colin Baigent, who directed the research for the UK's Medical Research Council, said a high dose was considered to be "about twice what the normal person would take".

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FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

April 7, 2005

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

FDA has asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

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FDA Announces Changes for All NSAIDs; Bextra Withdrawn From Market

FDA action taken on entire class of arthritis drugs. The U.S. Food and Drug Administration has announced actions which will be taken regarding the marketing of NSAIDs (nonsteroidal anti-inflammatory drugs). The actions include changes for COX-2 inhibitors, as well as prescription and non-prescription (over-the-counter) NSAIDs.

Highlights of FDA Action:

- Pfizer has been asked to withdraw Bextra from the market because "the overall risk versus benefit profile for the drug is unfavorable." Pfizer has agreed to suspend sales and marketing of Bextra in the U.S. pending further discussions with the FDA.
- The FDA has asked Pfizer to include a boxed warning in the Celebrex label (package insert) stating an increased risk of cardiovascular events and potentially life-threatening gastrointestinal bleeding associated with its use.
- The FDA has asked manufacturers of all other prescription NSAIDs to revise their labels to include the boxed warning stating an increased risk of cardiovascular events and potentially life-threatening gastrointestinal bleeding associated with their use.
- Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise labeling to include a Medication Guide for patients to increase awareness of the potential for cardiovascular and gastrointestinal adverse events associated with use of this class of drugs.
- The FDA is also asking manufacturers of all over-the-counter NSAIDs (i.e. Aleve, Advil) to revise labels to include more specific information about potential cardiovascular and gastrointestinal risks, and safe use of the drugs.
- The FDA is asking manufacturers of over-the-counter NSAIDs to include a warning about potential skin reactions. The label of prescription NSAIDs already includes warnings about potential skin reactions.

These actions by the FDA follow scrutiny of NSAIDs and COX-2 inhibitors provoked by the voluntary withdrawal of Vioxx by Merck in September 2004. After analyzing scientific data, including data collected after the drugs were approved, and a joint meeting of the FDA's Arthritis and Drug Safety and Risk Management Advisory Committees held February 16-18, 2005, the FDA made its decision.

Why Has Bextra Been Singled Out?

The reasons given for the withdrawal of Bextra from the market include:
- The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials that FDA believes may be relevant to chronic use.
- Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.
- Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

What Should Patients Do Who Take Bextra Or Other NSAIDs?

Patients currently taking Bextra should contact their doctor to consider alternatives to Bextra. Decisions about which specific drug you should take to treat your arthritis symptoms should be made by consulting your doctor and considering your individual condition and treatment needs.

The decision applies to the marketed COX-2 selective drugs (Bextra and Celebrex) as well as the non-selective NSAIDs.

This includes these COX-2 Selective NSAIDs:

- Celecoxib brand name Celebrex
- Valdecoxib brand name Bextra
- Rofecoxib brand name Vioxx

This also includes Non-selective NSAIDs including:

- Diclofenac brand names Cataflam, Voltaren, Arthrotec (combination with misoprostol)
- Diflunisal brand name Dolobid
- Etodolac brand names Lodine, Lodine XL
- Fenoprofen brand names Nalfon, Nalfon 200
- Flurbiprofen brand name Ansaid
- Ibuprofen brand names Motrin, Motrin IB, Motrin Migraine Pain, Advil, Advil Migraine Liqui-gels, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen, Profen, Ibuprohm, Children’s Elixsure, Vicoprofen, Combunox, Note: there are over-the-counter ibuprofen products and many OTC combinations.
- Indomethacin brand names Indocin, Indocin SR, Indo-Lemmon, Indomethegan
- Ketoprofen brand names Oruvail, Orudis, Actron, Note: there are over-the-counter ketoprofen products.
- Ketorolac brand name Toradol
- Mefenamic Acid brand name Ponstel
- Meloxicam brand name Mobic
- Nabumetone brand name Relafen
- Naproxen brand names Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac, Note: there are over-the-counter naproxen products.
- Oxaprozin brand name Daypro
- Piroxicam brand name Feldene
- Salsalate brand name Disalcid
- Sulindac brand name Clinoril
- Tolmetin brand names Tolectin, Tolectin DS, Tolectin 600

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