FDA Warnings for Teva Acid Reflux Drug

Posted By The Carlson Law Firm || 1-Jul-2011

With facilities all over the world and $16.1 billion in revenue in 2010, Teva Pharmaceutical Industries is the world’s largest generic drug manufacturer. Headquartered in Israel, the pharmaceutical giant recently announced its acquisition of another global leader, the Fortune 1000 company Cephalon. Even with its growth and success, Teva has also had some controversy with which to contend. In April 2011, the U.S. Food and Drug Administration (FDA) issued a warning regarding Teva’s dissolvable generic version of Prevacid, a heartburn drug.

Early this spring, the federal regulators warned that the generic pharmaceutical manufacturer’s heartburn drug may clump and cause problems for patients using an oral syringe or feeding tube. The generic in question, lansoprazole, reportedly does not disintegrate in water as expected, and can stick to walls of syringes and feeding tubes. While Teva is voluntarily withdrawing the 15 mg and 30 mg versions of the oral disintegrating tablet (ODT) product, some stock may still remain in medical facilities, pharmacies or in patients’ possession.

Problems with FDA warnings and recalls are not new to Teva. Last January, the regulatory watchdog issued warnings regarding the company’s Jerusalem production plant. In December 2009, the generic giant was issued a warning for its plant in Irvine, California. Some of the FDA concerns in 2009 related to inadequate testing of raw materials, failure to investigate study discrepancies and create corrective action plans, and failure to adequately test for contaminates. Earlier in 2009, the company was asked to recall Propofol, an anesthetic that has become widely associated with the untimely death of international superstar Michael Jackson.

The consequences of unsafe drugs in the marketplace can be dire. When medications don’t work as they should and cause harm, patients and their families can seek damages, which may include lost income, medical expenses, emotional distress, property damage and pain and suffering.

Generic medications are important because they make life-improving and life-saving drug therapies affordable and accessible; however competition and production costs may tempt drug manufacturers to cut corners. Pharmaceutical companies should realize that not complying with the FDA guidelines puts consumers at risk for harm and their companies at risk for losses.

Source: FDA warns against some use of Teva reflux drug


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