INFO - New warnings about the use of COX-2 inhibitors

[Guest guest]

The Danish Medicines Agency

5 July 2004

New warnings about the use of COX-2 inhibitors

The scientific Committee for Human Medicinal Products (CHMP) under the

European Agency for the Evaluation of Medicinal Products (EMEA) has

completed a scientific evaluation of the effect and safety involved in

using medicinal products containing the substances celecoxib,

etoricoxib, parecoxib, rofecoxib and valdecoxib (hereafter referred to

as selective COX-2 inhibitors). The medicinal products are sold in

Denmark under the names Arcoxia®, Celebra®, Dynastat®, Vioxx® and

Vioxxalt®.

As the pharmacological effect is the same for all of the medicinal

products mentioned, the CHMP regards adverse drug reactions observed in

one or more of the medicinal products as a " class effect " that must be

warned about for all medicinal products.

In the following, the main features of the CHMP's conclusions are

reviewed. More detailed material may be found at EMEA's website on the

internet.

Effect

The scientific review does not change the evaluation of selective COX-2

inhibitors' effect for the treatment of pain of e.g. arthritis and

osteoarthritis. Selective COX-2 inhibitors have a clinical effect equal

to the use of traditional (non-selective) non-steroid anti-inflammatory

medicinal products (NSAID).

Safety

The cardiovascular safety of using selective COX-2 inhibitors compared

to conventional NSAID medicinal products has been disputed. Patients

with known cardiovascular disease is warned against using selective

COX-2 inhibitors and it is emphasised that COX-2 inhibitors cannot

replace low-dose acetylsalicylic acid (ASA), e.g. Hjertemagnyl®,

Magnyl®, Magnyl svage®, for the prevention of blood clots.

The review of the documentation for the selective COX-2 inhibitors has

not shown an unambiguous clinical relevant advantage as regards safety

in the gastrointestinal tract compared to traditional NSAID medicinal

products. Selective COX-2 inhibitors should therefore - in conformity

with all other NSAID medicinal products - be used cautiously for

patients with increased risk of gastrointestinal adverse reactions (e.g.

elderly patients, patients with previous complicated ulcer or

NSAID-induced ulcer, patients undergoing blood-thinning (AK) treatment

or treatment with systemic glucocorticoids).

In combination with acetylsalicylic acid (ASA), the selective COX-2

inhibitors do not seem to have a better gastrointestinal safety than the

combination of traditional NSAID medicinal products and ASA. This is

also the case for patients undergoing treatment with low-dose ASA

(75-100 mg per day), who should therefore also be cautious when using

selective COX-2 inhibitors.

In clinical studies with selective COX-2 inhibitors, serious skin

reactions (e.g. -'s syndrome and toxic epidermal

necrolysis) have appeared in rare cases, but these reactions are also

seen by the use of traditional NSAID medicinal products. A warning about

these adverse reactions will be added to the product information of the

selective COX-2 inhibitors.

CHMP's conclusion

The relationship between the effect and adverse reactions of the

selective COX-2 inhibitors is changed but still positive. However, the

above mentioned warnings will be added to the product information of the

medicinal products concerned (summary of product characteristics and

package leaflet).

For further information, please contact Chief Medical Officer Steffen

Thirstrup on tel.: +45 4488 9187.

The Danish Medicines Agency, 5 July 2004

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

,

Do you know if naprosyn is still ok to take?

Thanks,

ette

[Guest guest]

,

Do you know if naprosyn is still ok to take?

Thanks,

ette

[Guest guest]

ette, Naprosyn (naproxen sodium) is not a COX-2 but rather a

nonselective NSAID. The cautions regarding the use of traditional NSAIDs

apply. In particular, GI adverse events are the most notable risk.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

Re: [ ] INFO - New warnings about the use of COX-2

inhibitors

> ,

>

> Do you know if naprosyn is still ok to take?

>

> Thanks,

> ette

[Guest guest]

ette, Naprosyn (naproxen sodium) is not a COX-2 but rather a

nonselective NSAID. The cautions regarding the use of traditional NSAIDs

apply. In particular, GI adverse events are the most notable risk.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

Re: [ ] INFO - New warnings about the use of COX-2

inhibitors

> ,

>

> Do you know if naprosyn is still ok to take?

>

> Thanks,

> ette