Black box added to Mobic label

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Black box added to Mobic label



October 27, 2005



Janis



Rockville, MD - Mobic (meloxicam, Boehringer Ingelheim

Pharmaceuticals) became a top-selling prescription drug for relieving

osteoarthritis (OA) and rheumatoid arthritis (RA) pain after Vioxx

and Bextra were withdrawn from the US market, but the US Food and

Drug Administration (FDA) has now announced additional safety

advisories for meloxicam [1].

These include a " black-box " warning on cardiovascular (CV) and

gastrointestinal (GI) risks and additional " warnings " language about

potential CV, GI, renal, and skin problems associated with the drug.

The change also includes a statement that Mobic is contraindicated

for treatment of perioperative pain associated with CABG surgery.

New focus on CV, GI risk

The black box warns, " NSAIDs may cause an increased risk of serious

cardiovascular thrombotic events, myocardial infarction, and stroke,

which can be fatal. This risk may increase with duration of use.

Patients with cardiovascular disease or risk factors for

cardiovascular disease may be at greater risk. "

The box also warns, " NSAIDs cause an increased risk of serious

gastrointestinal adverse events, including bleeding, ulceration, and

perforation of the stomach or intestines, which can be fatal. These

events can occur at any time during use and without warning symptoms.

Elderly patients are at greater risk for serious gastrointestinal

events. "

Additions to the " warnings " section of the label include:

Increased risk of serious CV thrombotic events, myocardial

infarction, and stoke.

Onset of new hypertension or worsening of preexisting hypertension,

especially in patients taking thiazides or loop diuretics.

Increased risk of fluid retention and edema, with a note that " Mobic

should be used with caution in patients with fluid retention,

hypertension, or heart failure. "

Increased of GI ulceration, bleeding, and perforation.

Renal toxicity.

NSAID-related skin problems such as s- syndrome.

Mobic is classified as a COX-2 inhibitor in some countries but not in

the US, where it is included in the category of nonselective NSAIDs.

Pharmacologically, the drug is thought to be more " COX-2 selective "

than conventional NSAIDs such as ibuprofen and naproxen but less so

than the highly selective COX-2 inhibitors celecoxib and rofecoxib.

CV risk associated with Mobic had become an issue following

unpublished data presented to an FDA advisory committee meeting

earlier this year that associated Mobic with a higher risk of heart

attacks than Vioxx.