Personal Injury Law

FDA seizes generic drugs at Michigan facilities and calls on experts to discuss how to limit liver injury in patients who take acetaminophen

By Hurley, McKenna & Mertz

As a personal injury lawyer, I am pleased to see that the FDA has been proactive in considering health hazards from generic drugs. Consider two recent instances where the FDA has both seized drugs for violating manufacturing standards and called for a panel of experts to scrutinize the link between acetaminophen and liver injury.

David Olmos reports for the Bloomberg News (6/26) "Generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by US authorities, who cited violations of manufacturing standards." The company had received a warning letter in October 2008 after inspections in May and June found deficiencies. Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said inspectors who saw the facilities in May 2009 "found 'serious violations' of manufacturing standards and 'serious deficiencies' in quality control."

The FDA said drugs "and raw ingredients for pain, heart ailment, and psychiatric medications were confiscated today at three Caraco facilities in Michigan to prevent the Detroit-based company from distributing its products until the manufacturing deficiencies are corrected."

Jared Favole reports on other recent FDA activity for the Dow Jones Newswires (6/26) stating "painkillers such as Tylenol will go under a microscope... as federal regulators and medical experts debate how to limit liver injury in patients who take the medicines." At issue is acetaminophen, which is the most widely used drug in America. Approximately "100 people die annually from accidentally overdosing on acetaminophen,? and over 50,000 are temporarily hospitalized. The Food and Drug Administration says the drug is safe if taken at recommended levels, but ?the drug's prevalence in a variety of pain relievers, fever reducers, and cough medicines means patients don't realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen."

According to Dow Jones, the FDA has been struggling with how best to control the issues surrounding acetaminophen since at least 1977, when an agency committee suggested labels for pain relievers contain a warning that they can damage a patient's liver. In April, the FDA mandated that over the counter drugs containing acetaminophen must have a label warning of liver injury. On Tuesday, the panel of experts voted to lower the maximum over the counter dosage and to ban drugs that combine narcotics and acetaminophen, including Vicodin and Percocet. Perhaps warning labels and other possible safety measures - including reducing recommended dosage levels, limiting the number of pills or liquid in each drug containing acetaminophen, and eliminating medicines that combine acetaminophen with other ingredients - could save many lives per year.

Full post as published by Chicago Medical Malpractice Lawyer Blog on July 01, 2009 (boomark / email).