The black box warning for NSAIDs related to cardiovascular risk reads as follows, in an example from the labeling for the NSAID naproxen (Naprosyn®): The FDA has required a block box warning about cardiovascular thrombotic events be placed in the package description of all NSAIDs other than aspirin, including COX-2 specific and selective agent, and patients at high risk for cardiovascular disease need to weigh the risks and benefits with their physician before taking any NSAID or (COX-2 specific or selective agent). Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. These events can occur at any time during use and without warning symptoms. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. The black box warning for NSAIDs related to gastrointestinal risk reads as follows, in an example from the labeling for the NSAID naproxen (Naprosyn®): These drugs can considerably reduce your risk of an ulcer and internal bleeding. Drugs that reduce stomach irritation include misoprostol (Cytotec), or a proton pump inhibitor such as omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix), lansoprazole (Prevacid), or rabeprazole (Aciphex).If you develop gastrointestinal problems, your physician may switch you to another drug (such as a COX-2 selective inhibitor – see the below section on this type of agent) or may add a drug to help reduce stomach irritation. ![]() Limit alcohol intake (since alcohol can also irritate your stomach).Take NSAIDs at the end of a full meal or with an antacid.To help reduce irritation of the stomach and prevent an ulcer,.Stop the drug and call your physician immediately if you have any severe abdominal pain or a black, tarry stool (bowel movement) or any blood in your stool.This is an urgent problem requiring prompt medical attention. Perforation, meaning a “hole” in the stomach, can also occur in rare cases. In the worst cases, such an erosion can lead to internal bleeding, which may be life-threatening. In severe cases, NSAIDs can irritate the lining of your stomach so that an ulcer (a small erosion) forms. They are most likely to be stomach irritation and the sensations known as "heart burn" (which has nothing to do with your heart). Gastrointestinal symptoms are the most common side effects of NSAIDs.More rarely, NSAIDs can contribute to heart problems and increase the risk of cardiovascular conditions. The most common side effects of NSAIDs are gastrointestinal problems, including stomach irritation and reflux. What are possible side effects of NSAIDs? If any of these guidelines are not clear, or if you think it does not apply to you, be sure to discuss the issue with your physician. Although most side effects are minor, there is still a genuine concern regarding gastrointestinal problems (such as ulcer development) and cardiovascular side effects. Being aware of the possible side effects of these drugs can make them even safer to use. The risk of serious side effects is small, but there are some serious considerations with these medications, as discussed below. Most side effects are minor and easily reversible by discontinuing the drug or by adding a drug to counter such effects. NSAIDs are generally tolerated very well by many patients, which is fortunate because these drugs are often very helpful for people with pain and inflammation. A more recent group of NSAIDs known as COX-2 selective or COX-2 specific inhibitors are covered in a separate article on COX-2 inhibitors – presently limited to the agent celecoxib (Celebrex.) NSAIDs do not include drugs that are purely pain relievers, such as acetaminophen (Tylenol) or codeine. Here is an extensive list of various NSAIDs: They include such drugs such as asprin, ibuprofen and naproxen. ![]() Some of these drugs require a prescription, while others are available without one (over-the-counter or OTC). Nonsteroidal anti-inflammatory drugs are a group of drugs that are prescribed to reduce the pain and inflammation of arthritis.
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