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Drug Warnings

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Dangerous Drug Warnings and Recalls

The FDA issues various types of warnings to consumers and healthcare professionals after a drug has been released in the market if issues arise relating to its safe use based on adverse side effects reported by consumers.  Based on the severity, the FDA has two basic options.  It can choose to recall the product and completely remove it from the market shelves or it can issues a product advisory such as a “ black box warning” that must appear on the drugs printed material. The challenge is to reach out and inform current users of this new warning or complete recall as the FDA has no record of  the consumers of the drugs.

After a drug has been on the market for some time, issues pertaining to its safety frequently emerge. These issues arise either through continued clinical research or more commonly, through adverse events reported by consumers. Following these concerns, the FDA has two options. It can choose to completely remove the drug from the market or it can issue an advisory, the strongest of which is a black box warning which appears on the drug's printed materials, both inside the packaging and on materials developed for the doctors who may prescribe the drug.

Blackbox warnings and outright recalls have been on the rise since 2004.  The goal of Recallwarning.com is to serve help communicate FDA and Voluntary recalls and warnings.

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