Acetaminophen Black Box Warning by FDA
June 30, 2009 by allenh
Filed under Box Warning, Consumer Alerts, Defective Drugs, Defective Products, FDA, HEALTH, Top Stories
6-30-2009
Acetaminophen /Tylenol – Black Box Warning Recommended by the FDA
The FDA has recommends that the a black box warning is added to the labels of prescription pain and cold products that contain acetaminophen wich is widely known under the brand name Tylenol.
The FDA states that there is a signifigant health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products.
Because acetaminophen is important for the use of treating pain and fever they do not want to remove it from the market.
Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
Acetaminophen is the active ingredient in Tylenol.
It is also found in many other over-the-counter medications you can buy at the drug store and in prescription drugs your doctor prescribes:
Common names include:
- Actifed
- Alka-Seltzer Plus
- Benadryl, Butalbital
- Co-Gesic
- Contac
- Darvocet
- Excedrin
- Fioricet
- Lortab
- Midrin
- Norco
- Percocet
- Robitussin
- Sedapap
- Sinutab
- Sudafed
- TheraFlu
- Unisom With Pain
- Vick’s Nyquil
- Vick’s DayQuil
- Vicodin,
- Wygesic
- Zydone
Acetaminophen in overdose can seriously damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.
Accordning to Research, hundreds of people each year are diagnosed with acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.
Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.
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