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FDA Proposes Stringent Warnings Labels for Pain Relievers

by Monisha on  December 20, 2006 at 11:02 AM Drug News   - G J E 4
FDA Proposes Stringent Warnings Labels for Pain Relievers
U.S. Food and Drug Administration have proposed that labels of commonly available painkillers should carry sterner warnings, that mention potential side effects. Drugs such as Tylenol and Aspirin used as pain relievers are easily available to the public.
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The FDA has ruled that, the warnings will be compulsory and will have to be displayed prominently on the labels. The language has to be simple and standardized, informed Dr.Charles Ganley who is the director of the FDA's, Office of Nonprescription Products, Center for Drug Evaluation and Research. Several manufacturers have already provided the required statutory warning on the labels of the pain killers.

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More than thousand deaths are linked to the use of pain relievers. The warnings will keep the public aware of the potential hazards that can be caused due to the excessive use of these drugs. Tylenol, which is the trade name of a drug called acetaminophen can cause liver damage. Non Steroidal Anti-inflammatory Drugs (NSAIDS) such as Aspirin, Ibuprofen can cause bleeding within the stomach .Over 200 million Americans are estimated to use pain reliever drugs like acetaminophen, said Dr. Ganley.There have been several reported cases of liver failure following the use of acetaminophen. The latest change in the label on acetaminophen will include warning pertaining to toxicity to liver, when used in combination with other drugs or with alcohol, written in bold letters. The name Acetaminophen will now be written in bold type across the container prominently. Similarly the warnings on containers of NSAID drugs will also have to emphasize the chances of bleeding that it can cause in stomach in elderly people above 60 years ,if they are using blood thinners, habituated to alcoholic drinks or taking the drug for much longer than was advised by he medical practitioner. The FDA are also considering to limit the number of tablets sold in one package as it is done in the U.K.

The recently proposed changes in labeling are based on scientific research and also advice of experts. It is still not clear when the final ruling would become binding.

Source: Medindia
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