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FDA Increases Safety Information on Acetaminophen and NSAID Labels

By Oguz Ozdemir

The Food and Drug Administration (FDA) recently decided to require manufacturers of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) to forewarn users of the potential risk of liver damage and internal bleeding as a result of using either of these products. The revised warning labels include over-the-counter (OTC) products as well as prescription medications.

Acetaminophen is commonly recognized by most people as Tylenol, an OTC product that is used to treat the common cold as well as relieve pain and reduce fevers in children and adults. In its prescription form it is found in medications like Vicodin and Percocet.

NSAIDs are also used to treat pain and are available in a variety of forms such as aspirin and naproxen but more commonly it is purchased as ibuprofen.

The potential liver problems associated with acetaminophen are the result of taking too much of it either through a larger dose than is recommended on the label or as a result of taking it in other forms without even knowing it. Acetaminophen is available by itself or is included in many OTC medications to treat colds, flu symptoms, allergies and insomnia. In prescriptions it is listed under active ingredients as acetaminophen or as APAP.

The risk of liver damage can happen without you even realizing it until it is too late. Early signs include nausea, loss of appetite and vomiting which can be easily mistaken for the flu. Once liver damage reaches a certain point it can quickly turn into liver failure and even result in death. If you take Warfarin, a blood thinner, you should talk with your doctor before taking acetaminophen as it could increase your risk of bleeding.

The use of NSAIDs has resulted in cases of stomach bleeding in people over 60 years of age, people who have a history of ulcers or bleeding, or people who currently take blood thinners. You could also have problems if you take NSAIDs in higher doses, for long periods of time, if you already have liver problems or if you drink at least three alcoholic beverages a day.

At the FDA advisory meeting on June 29 and June 30, 2009, the committee agreed to replace the previous warning labels from 2006. The new labels have more specific information regarding the problems that have resulted through increased doses by deliberate as well as unknown actions. The medications themselves are effective when taken as directed but if you unknowingly use other medications that contain these two drugs you have already increased the levels of acetaminophen or NSAIDs and increased your risk of liver damage or stomach bleeding.

If you, a loved one or someone you know has experienced liver damage of any kind or stomach bleeding as a result of inadvertently taking higher doses of acetaminophen or NSAIDs due to negligent warning labels, contact the law firm of Napoli Bern Ripka LLP at 1-888-LAW IN NY. Our professional team of lawyers can put their expertise in dealing with effects caused by FDA drugs and get you the compensation that you deserve.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on July 27, 2009 (boomark / email).