BANGALORE (Reuters) - Johnson & Johnson unit Janssen said it was in discussions with regulatory authorities in Europe and Canada to address trace amounts of a fungicide found in certain lots of its HIV drug Prezista (darunavir).
<p class="datestamp"> <small> <em>Last Updated: 2011-05-11 10:30:04 -0400 (Reuters Health)</em> </small> </p> <p class="lead">BANGALORE (Reuters) - Johnson & Johnson unit Janssen said it was in discussions with regulatory authorities in Europe and Canada to address trace amounts of a fungicide found in certain lots of its HIV drug Prezista (darunavir). </p> <p>This comes on the back of a series of J&J recalls related to the presence of the chemical. </p> <p>The discussions were initiated by Janssen after it received four consumer reports of an uncharacteristic musty, moldy odor. </p> <p>Janssen's investigation determined that the odor is likely caused by trace amounts of tribromoanisole (TBA) -- a fungicide used in packaging materials -- found in bottles sourced from a common supplier. </p> <p>A very small number of patients reported temporary gastrointestinal symptoms after taking the HIV drug, but there were no reported serious adverse events caused by the presence of TBA. </p> <p>"We do want to make it clear that patients should not stop taking their medication," the company said. </p> <p>Anyone experiencing an uncharacteristic odor associated with Prezista 400-mg or 600-mg tablets should return their tablets to their pharmacist for immediate replacement, Janssen added. </p> <p>The countries affected include Canada, the United Kingdom, Ireland, Germany and Austria. Discussions with regulatory authorities are underway to determine the appropriate course of action in each market, the company said in a statement. </p> <p>The widespread recall of J&J's Tylenol pain reliever and other medications also originated with complaints of a musty odor. The company has recalled more than 300 million bottles and packages of adult and children's consumer medicines since early 2010. </p> <p>Although no injuries have been linked to the ongoing recalls, they have sullied J&J's reputation, pressured its share price and sparked Congressional investigations. </p> <p>TBA is a byproduct of a chemical preservative sometimes applied to wood and often used in the construction of pallets on which products are transported and stored. </p> <p>An internal investigation is underway with suppliers to evaluate all potential sources of TBA, Janssen said. </p> <p> <font size="1">Copyright © 2011 Reuters Limited. All rights reserved.Republication or redistribution of Reuters content, including by framing orsimilar means, is expressly prohibited without the prior written consent ofReuters. Reuters shall not be liable for any errors or delays in thecontent, or for any actions taken in reliance thereon.Reuters and the Reuters sphere logo are registered trademarks andtrademarks of the Reuters group of companies around the world.</font> </p> </div>