Personal Injury Law

Dangerous Drug Warning

Dangerous drugs have been placed into the stream of commerce by manufacturers for years without warnings. Recently, the Food and Drug Administration (FDA) ordered the manufacturer of two drugs commonly used before colonoscopies to add warnings to the products. These are commonly referred to as ?black box? warnings.

Visicol and OsmoPrep are oral sodium phosphate medicines used for bowel cleansing before colonoscopies. There have been reports of serious kidney injuries linked to their use. The FDA has received reports of 20 cases of kidney injury associated with the use of OsmoPrep, including three cases of acute kidney injury.

The onset of kidney injury varied, occurring in some cases within several hours of use and in other cases up to 21 days after use phosphate products for bowel cleansing.

The FDA ordered the manufacturer of Visicol and OsmoPrep to prepare a risk evaluation and mitigation strategy, distribute a medication guide to alert patients to the risk of acute kidney injury, and conduct a clinical trial to further assess the risk of acute kidney injury.

Importantly, the FDA also recommended that consumers not use over-the-counter oral sodium medications as they have the potential to cause similar injuries

Full post as published by Georgia Injury Lawyer Blog on December 17, 2008 (boomark / email).