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In the News

New and Important Update on the COX-2 Medication Bextra

By Ed Nguyen, M.D., Attending Physician at 75th St. & 126th St. Medical, Ocean Pines Medical & Doctors Weight Control & Wellness centers, Ocean City, MD.

The past six months have seen quite a flurry of activity over the cyclo-oxygenase-2 (COX-2) medications. These medications were originally introduced six years ago as alternatives to the nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of arthritic pain. However, late last year, Vioxx (rofecoxib), produced by Merck, was voluntarily withdrawn from the marketplace due to increasing concerns over adverse cardiovascular effects in patients on Vioxx therapy. Now, it appears that Bextra (valdecoxib) has become the latest COX-2 medication to be withdrawn from the market. The sale and marketing of this drug, produced by the pharmaceutical company Pfizer, has been suspended upon request from the U.S. Food and Drug Administration (FDA), following a review in February of this year by an advisory committee over the safety and efficacy of the COX-2 drugs.

Bextra had previously been contraindicated for use in patients who recently had undergone coronary artery bypass surgery. However, due to inadequate data concerning potential cardiovascular effects from long-term use of Bextra, in addition to concerns over reports of serious skin reactions and some fatalities in patients on long-term Bextra usage, the FDA felt compelled to request for the withdrawal of the drug, as of April 2005.

All patients who are currently using valdecoxib to treat their osteoarthritic pain are strongly encouraged to contact their personal health care providers as soon as possible. Alternate means of pain management are advisable and may include tylenol (acetaminophen), aspirin therapy, which has a strongly beneficial and protective effect against cardiovascular events, or perhaps one of the NSAID medications. Precaution should be taken with some of these medications, however, in patients with a history of gastrointestinal conditions such as bleeding ulcers or gastritis. Currently, the COX-2 medication Celebrex (celecoxib), also produced by Pfizer, remains on the market, and the FDA advisory committee in February had suggested that Vioxx, too, was safe enough to be allowed back onto the market, albeit with probable strong black box warnings.

Patients who wish to learn more about the FDA's recommendations over the COX-2 drugs can access the government website at http://www.fda.gov/cder/drug/infopage/cox2/default.htm. Alternatively, concerned patients can also call toll-free at 1-888-INFO-FDA (888-463-6332).

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