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On Monday, a consortium of drug companies lobbied the FDA, saying, “products that include acetaminophen (Tylenol) should stay on the market” despite concerns of widespread liver damage. Drug manufacturers offered to more clearly “warn buyers about the risks of liver damage linked to the Tylenol” instead of the FDA’s more drastic options: a full-out ban.

Too much Tylenol has been causing acute fulminate liver failure for decades. So why is the FDA acting now? FDA officials are specifically worried about “cold and cough” products that combine Tylenol with other medications. Patients can be at risk, by unknowingly, taking too much of these medication. According to Reuters, "FDA officials consider the ingredient safe when taken as directed but worry that the growing number of liver failure cases shows that overdose remains a serious public health problem." Furthermore, the FDA wants to lower the maximum daily dose of acetaminophen. The FDA wants stronger warnings on the following product: Tylenol, Vicks Formula 44, NyQuil, Theraflu, Percocet, Robitussin Cough Cold & Flu, Dristan Cold and other drugs that use acetaminophen.

An FDA ban, or a strict warning, will hurt the bottom-line of the following companies: Novartis (NYSE: NVS), Johnson & Johnson (NYSE: JNJ), Proctor & Gamble (NYSE: PG), GlaxoSmithKline (NYSE: GSK) and Teva Pharmaceuticals (NASDAQ: TEVA). We believe that Endo Pharmaceuticals (NASDAQ: ENDP) and Abbott Laboratories (NYSE: ABT) are most at risk, since combination products Percocet and Vicoden, respectively, make up a large portion of annual sales. Likewise, an FDA ban will also damper Cadence Pharmaceuticals' (NASDAQ: CADX) near-term pipeline as they are seeking to sell an injectable acetaminophen formulation.

Disclosure: Author holds no position in NVS, JNJ, PG, GSK, TEVA, ENDP, ABT, CADX.

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This article has 4 comments:

  •  
    People have no idea how bad these medications are for their health.Just because something is sold over the counter does not mean it is safe. As a retired chiropractor, I can tell you the chiropractic profession has been warning the public for years about acetaminophen. The side effects can be deadly.
    Jul 01 09:30 AM | Link | Reply
  •  
    I doubt there will be a ban...

    Oh, and Vicodin is spelled incorrectly...
    Jul 01 01:13 PM | Link | Reply
  •  
    thanks for the edit, I changed it on my column. I doubt there will be a ban also... we'll see what happens.
    Jul 01 11:13 PM | Link | Reply
  •  
    I agree. As a Chiropractor I have seen the damage that acetaminophen caused to people. I hope and pray for the ban. It will save many lives.


    On Jul 01 09:30 AM sliman wrote:

    > People have no idea how bad these medications are for their health.Just
    > because something is sold over the counter does not mean it is safe.
    > As a retired chiropractor, I can tell you the chiropractic profession
    > has been warning the public for years about acetaminophen. The side
    > effects can be deadly.
    Sep 22 11:19 PM | Link | Reply