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Standard FDA Information About Mobic
Official Claim Of Cost Savings Over Celebrex
News Release A
Third New Arthritis Drug Approved
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:
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:
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:
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.)
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
Posted: 5/10/00 |

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Thumbs Up For
Arthritis Drug A Third New Arthritis Drug Approved |
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| 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.
Official Claim Of Cost Savings Over Celebrex
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