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Standard FDA Information About Mobic

Official Claim Of Cost Savings Over Celebrex

News Release A Third New Arthritis Drug Approved
 

 


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Standard FDA Information About Mobic

Mobic®
Brand Name: Mobic®
Active Ingredient:   meloxicam
Strength(s): 7.5mg
Dosage Form(s):   Tablet
Company Name:    Boehringer Ingelheim Pharmaceuticals
Availability:         Prescription only
*Date Approved by FDA:   April 14, 2000
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Mobic used for? 

Mobic is used to relieve the signs and symptoms of osteoarthritis in adults.

Who should not take Mobic? 

You should not take Mobic if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.

Special Warnings with Mobic:

Serious problems from stomach ulcers such as bleeding are recognized complications in people treated with NSAIDs. Similar problems have occurred in people treated with Mobic. The likelihood of stomach problems increases the longer you take drugs like Mobic. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Mobic and call your health care provider right away.

Check with your health care provider. Mobic may not be right for you, if you:

  • have had ulcers or stomach bleeding
  • have had asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs
  • have severe kidney problems
  • have severe liver problems
  • are pregnant

General Precautions with Mobic: 

Do not stop taking any medications that you have been prescribed without first talking to your health care provider.

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.

Mobic can cause your body to retain fluid and swell. Your health care provider will decide if Mobic is right for you, if you:

  • retain fluids
  • have high blood pressure
  • have heart failure

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction also has occurred after taking NSAIDs. Mobic should not be given to aspirin-sensitive patients.

The safety and effectiveness of Mobic in patients below the age of 18 years has not been determined.

What should I tell my doctor or health care provider? 

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medications can interact with Mobic, review all medications that you are taking with your health care provider, including those that you take without a prescription.

Your health care provider may have to adjust your dose or monitor you more closely if you take:

  • certain blood pressure medications called ACE-inhibitors
  • furosemide
  • lithium
  • warfarin
  • aspirin

What are some possible side effects of Mobic? (This is NOT a complete list of side effects reported with Mobic. Your health care provider can discuss with you a more complete list of side effects.)   

  • Indigestion
  • Upper respiratory tract infection
  • Diarrhea
  • Joint pain
  • Stomach pain
  • Nausea

Rarely, serious ulcershave occurred in patients taking Mobic.

For more detailed information about Mobic, ask your health care provider.

Link to Mobic's Approved Labeling  ../../graphics/Pdf.gif (146 bytes)

Back to Entry Page

Posted: 5/10/00
Updated: 8/2/00

 


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Thumbs Up For Arthritis Drug
A Third New Arthritis Drug Approved

 
The Associated Press
W A S H I N G T O N, April 14 —A third new drug for people suffering from the pain of arthritis has been approved by federal regulators.
    
The Food and Drug Administration said today it has approved meloxicam tablets for the treatment of osteoarthritis.
     Meloxicam will be marketed under the name Mobic by Boehringer Ingelheim Pharmaceuticals and Abbott Laboratories and is expected to be available in early May. The wholesale price was expected to be $1.98 per tablet and dosage is once a day.
     Mobic is the third new arthritis drug approved in the last two years, joining Celebrex and Vioxx.
     Millions of people depend on aspirin, ibuprofen, naproxen and other pills to relieve pain. But these can cause ulcers, stomach bleeding and other side effects, especially in long-term users.
     In clinical trials Mobic had a low instance of gastrointestinal side effects, the manufacturer said.
 

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Mobic etc. (Meloxicam)
Mobic (Meloxicam) is a “preferential COX-2 inhibitor” nonsteroidal anti-inflammatory drug (NSAID). NSAID’s are used to treat inflammation, mild to moderate pain, and fever and are called “nonsteroidal” because they are not related to the steroid drugs (synthetic drugs that closely resemble cortisol, a hormone that is naturally produced by the adrenal glands). Steroids work by suppressing the immune system, whereas NSAID’s work mainly by preventing the formation of prostaglandins, hormone-like substances which trigger pain and inflammation. Prostaglandins are produced within the body's cells by the enzyme cyclooxygenase (Cox). In 1989 scientists discovered that there are two varieties of the Cox enzyme - which came to be known as COX-1 and COX-2. COX-1 is continuously secreted within the stomach and duodenum, and is important for maintaining a healthy stomach lining, normal kidney function and the clotting action of blood platelets. In contrast, the COX-2 enzyme is primarily found at sites of inflammation.

The conventional, first generation NSAID’s (aspirin, diclofenac, ibuprofen, indomethacin, naprosyn and piroxicam etc.) work by inhibiting both COX-1 and COX-2 enzymes. By blocking COX-2 they are effective in relieving pain and inflammation, but by inhibiting COX-1 they often produce unacceptable gastrointestinal side effects including diarrhea, bloating, heartburn, upset stomach (dyspepsia) and ulcers. In 1998, with the approval of Celebrex (Celecoxib), a new type of NSAID came onto the market, called the “selective COX-2 inhibitor”. Followed by Vioxx (Rofecoxib) and Bextra (Valdecoxib), the COX-2 inhibitors vary in their selectivity for COX-2 over COX-1. Though the interpretation of studies measuring relative COX-2 to COX-1 selectivity is subject to much debate, Celebrex (Celecoxib) is believed to be some 375 times more selective; Vioxx (Rofecoxib) 800 times more selective; and Bextra (Valdecoxib) is said to show 90 times greater selectivity for COX-2 than either Rofecoxib or Celecoxib. Future COX-2’s that are currently under review include Etoricoxib and Parecoxib, the first injectable COX-2 inhibitor. Another NSAID, Mobic (Meloxicam) has some COX-2 selectivity (estimated at 5-50 times) and is referred to as a preferential COX-2 inhibitor. In general, the COX-2 inhibitors have been shown to provide excellent pain relief and cause significantly less GI toxicity than the conventional nonselective NSAID’s. However, they do not seem to offer a clinical advantage when it comes to the potential for kidney damage, and there have been some concerns over the potential for increased cardiovascular risk.


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Official Claim Of Cost Savings Over Celebrex

Boehringer Ingelheim
April 27, 2003
About Boehringer Ingelheim
News

MOBIC® Data Demonstrate Favorable Gastrointestinal and Cardiovascular Safety Profile
 

Study Results on Third New NSAID Approved in US for Osteoarthritis to be Presented at Annual European Congress of Rheumatology,
June 14

Ridgefield, CT, May 25, 2001 – New findings from a pooled analysis of 35 clinical trials with 27,039 patients, of whom 10,158 were taking the nonsteroidal anti-inflammatory drug (NSAID) MOBIC® (meloxicam) at the recommended starting dose of 7.5mg daily, demonstrate that MOBIC has a favorable gastrointestinal (GI) tolerability profile and a low incidence of GI adverse events. MOBIC is indicated for the relief of the signs and symptoms of osteoarthritis and is the third NSAID approved by the Food and Drug Administration (FDA) in the past two years after Celebrex®* (celecoxib) and Vioxx®** (rofecoxib). Efficacy and safety of MOBIC are further supported by an extensive clinical trial database of more than 32,000 patients.

Also important to note, in these 35 trials, rates of cardiovascular adverse events were low and similar for MOBIC and two other commonly prescribed NSAIDs. Abstracts on these study findings will be presented during the Annual European Congress of Rheumatology on June 13-16, 2001 in Prague. Copies of the abstracts currently are available on www.eular.org.

These safety findings are especially important in light of the medical community’s concern about GI and cardiovascular side effects of NSAIDs. There are approximately 107,000 hospitalizations each year in the US from serious NSAID-induced GI side effects (such as GI bleeds, or stomach ulcers) – with annual hospital costs exceeding $1 billion. Likewise, many osteoarthritis patients are older than 65, and many of these patients suffer from co-morbid conditions including cardiovascular disease. Therefore, when choosing a medication to treat osteoarthritis, it is important to strike a balance between efficacy and overall safety.

Clinical trials also demonstrate that MOBIC® 7.5mg daily and 15mg daily were comparable in efficacy to the commonly prescribed NSAIDs, diclofenac SR 100mg daily and piroxicam 20mg daily.

MOBIC, available in the US since April 2000, has been used by more than 30 million patients in 100 countries. MOBIC offers a balance between reliable efficacy and overall safety at a cost of about 20 percent less than Celebrex and Vioxx. Given the chronic nature of osteoarthritis, the benefit of this long-term savings can be felt by both physicians and patients.

The most common GI adverse effects associated with MOBIC are diarrhea, dyspepsia and nausea. As with other NSAIDs, MOBIC is not indicated for prevention of thromboembolic events and is not a substitute for aspirin or other drugs indicated for cardiovascular prophylaxis.

MOBIC is contraindicated in patients who have experienced asthma, itching or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. As with all NSAIDs, serious GI toxicity such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine can occur at any time, with or without symptoms.

MOBIC was developed by Boehringer Ingelheim and is co-marketed with Abbott Laboratories.

NOTE TO REPORTERS:

Please contact Steven Immergut CPR Worldwide 212/583-9290 to arrange interviews with:

Dr. M. Michael Wolfe, Boston University School of Medicine

Company spokesperson(s) from Boehringer Ingelheim and/or Abbott Laboratories

*CELEBREX is a registered trademark of G.D. Searle & Co.

**VIOXX is a registered trademark of Merck & Company, Inc.

  © 2002 Boehringer Ingelheim Corporation. All rights reserved.


 

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