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FDA Alert: 4/7/2005:

• Based on the currently available data (celebrex), FDA has
concluded that an increased risk of serious adverse ………..
events appears to be a class effect of non-steroidal anti-
inflammatory drugs (NSAIDs) (excluding aspirin).

• FDA has requested that the package insert for all NSAIDs,
including Celebrex, be revised to include a
………………………..to highlight the potential increased risk of
CV events and the well described risk of serious, and potentially
life-threatening, gastrointestinal bleeding.

• FDA has also requested that the package insert for all NSAIDs
be revised to include a contraindication for use in patients
immediately post-operative from ……………..

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PARACETAMOL (ACETAMINOPHEN)

¨ Paramol®, Cetal®, Adol®, Abimol®,Panadol®.

¨ It is analgesic and antipyretic with few anti-inflammatory
effect.

¨ The exact mechanism of action is not well understood. Some
studies supposed that paracetamol inhibit COX-3 enzyme so
prevent brain prostaglandins. While other supposed that is
selective inhibitor of COX-2 so it inhibits both brain and
peripheral prostaglandin.

¨ Immediaterelease, extendedrelease, effervescent, disintegrating, rapidrelease, and
chewable tablets; capsules; liquid drops; elixir; suspension; suppositories

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