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Friday, October 28, 2016

By Melissa Healy, Los Angeles Times

LOS ANGELES — Apparently, the FDA’s warning four months ago was missed by many physicians, pharmacists and patients, so the drug agency, in an unusual move, saw fit Monday to remind us: Stop writing prescriptions for, stop dispensing prescriptions for, and stop taking medications containing more than 325 milligrams of acetaminophen.

Your liver will thank you, since acetaminophen overdose has overtaken viral hepatitis infection as the most common cause of acute liver failure. It is now the second most common cause of liver failure requiring transplantation in the United States.

“These products are no longer considered safe by FDA and have been voluntarily withdrawn” by the manufacturers, the FDA said.

Just four months ago, the FDA called for doctors, dentists and pharmacists to stop recommending the higher dose, which, the FDA said, has demonstrated no superiority over the lower dose but poses dangers to the liver. The FDA does not usually have to repeat itself. But acetaminophen has become a workhorse of our home medicine chests, and an ingredient contained in many combination medications, including the opiate pain-relievers Percocet and Vicodin and in such over-the-counter stalwarts as Benadryl, Excedrin, Nyquil, Robitussin, Theraflu and Vicks.

“We encourage pharmacists to return them to the wholesaler or manufacturer,” the FDA said, and to remove the product codes for prescription medications containing such doses from their automatic reordering systems. When patients come to fill prescriptions for products containing more than 325 mg of acetaminophen, the FDA recommends that pharmacists call the prescriber to discuss a lower dose.

As explained by Harvard Medical School’s Family Health Guide, most acetaminophen is broken down into harmless substances that are removed from the body in urine. “But a small percentage is rendered into a compound that’s extremely harmful to cells,” the guide says.

The compound is known by the acronym NAPQI, and it’s combined with an antioxidant called glutathione to make it safe to ingest. But in the case of an overdose, there’s “not enough glutathione to sop up NAPQI,” making liver damage a threat.

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  • pat

    the FDA is only covering its ass. chkitout:

    Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
    Donald W. Light
    Rowan University, School of Osteopathic Medicine; Harvard University – Edmond J. Safra Center for Ethics

    Joel Lexchin
    York University

    Jonathan J. Darrow
    Harvard Medical School

    June 1, 2013

    Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013, Forthcoming

    Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.

    Number of Pages in PDF File: 11

  • Frank’s Inatra

    Those who harbor utopian delusions work very hard to undermine the institutions and traditions, such as private property, upon which civilization depends.