FDA Warning: Acetaminophen Linked to Fatal Skin Reactions
Millions of people use acetaminophen, better known by the brand name
Tylenol, for treating everything from fevers and muscle aches to
headaches. It’s widely available over the counter (OTC), as well as used
in many prescription medications to treat pain, allergies, sleeping
problems, coughs, colds and more.
Because it’s so common and easily accessible, most people believe
it’s perfectly safe, but a new warning from the US Food and Drug
Administration (FDA) serves as an important reminder that even popular
OTC medicines can be dangerous, and even deadly.
FDA Warning: Acetaminophen Linked to Fatal Skin Reactions
After reviewing data from the FDA Adverse Event Reporting System
(FAERS), the FDA found 107 cases of serious skin reactions linked to
acetaminophen products from 1969 to 2012.
Sixty-seven of them required hospitalization while 12 lead to death.
The data, coupled with several cases documented in medical literature,
has led the FDA to require a warning about potential skin reactions be
added to prescription acetaminophen products.
Further, the agency says they will “work with” manufacturers to get
such warnings added to OTC products. The skin reactions linked to
acetaminophen include:
- Stevens-Johnson Syndrome (SJS): This reaction
begins with flu-like symptoms that progress into a painful purple or red
rash that blisters and causes the top layer of your skin to slough off.
This can lead to serious infections, blindness, damage to internal
organs, permanent skin damage and even death.
- Toxic Epidermal Necrolysis (TENS): TENS also
typically begins with flu-like symptoms (cough, headache, aches, fever)
and progresses into a blistering rash. Layers of the skin may peel away
in sheets, and hair and nails may fall out. TENS is often fatal,
typically as a result of infection.
- Acute Generalized Exanthematous Pustulosis (AGEP): This
skin eruption causes numerous pustules to appear on the skin, often
accompanied by fever. This condition typically resolves within two weeks
once the acetaminophen is stopped.
Time magazine reported:
“It’s not clear why the skin conditions have not
emerged as a health concern sooner, given how many people take the
pain-killing medication. Health officials say it’s too soon to determine
whether dose is an issue, or whether the combination of acetaminophen
with other ingredients or medications causes the adverse events.
Often, such side effects only become apparent once a drug reaches
market and is used by millions of patients, since manufacturers cannot
anticipate every potential interaction between their product and
others.”
Skin Reactions Can Occur Any Time You Take Acetaminophen and Certain Other Medications
While the main cause of SJS, TENS and AGEP is the consumption of
certain medications, no one knows exactly why it occurs, or what makes
certain people more at risk. What is particularly alarming is that it
can occur at any time,
even if you’ve taken the medication in the past without issue. The FDA reported:
“A serious skin reaction can occur at any
time, even if you’ve taken acetaminophen previously without a problem.
There is currently no way of predicting who might be at higher risk. If
you’ve ever had a skin reaction when taking acetaminophen, don’t take
the drug again…“
Furthermore, acetaminophen is
not the only medication linked to these serious skin reactions. Other drugs commonly associated with SJS include:
- Anti-gout medications, such as allopurinol
- Nonsteroidal anti-inflammatory drugs (NSAIDs), often used to treat pain
- Penicillins, which are used to treat infections
- Anticonvulsants, which are used to treat seizures
The Second FDA Warning for Acetaminophen in Two Years
It was just two years ago when the FDA asked all markers of
prescription acetaminophen products to limit the amount to 325
milligrams per capsule to reduce the risk of liver injury. They also
required a Boxed Warning, the FDA’s strongest warning, to call attention
to the serious risks of liver injury from this drug.
Just as many are unaware of the potential for skin reactions, many
are unaware that acetaminophen is toxic to your liver, and is actually
the number one cause of liver failure in the US. It’s surprisingly easy
to take too much acetaminophen because it’s widely used in cold and flu
and other over-the-counter medications, as well as in prescription
painkillers like Vicodin and Percocet. Further, it doesn’t have to be
one large overdose to cause an issue; one study found that you’re
more likely to
die from a “staggered overdose” (taking just a little bit too much for
several days or weeks) of Tylenol than from a single large overdose.
Acetaminophen Too Risky for Minor Aches and Pains?
There are other serious health risks associated with acetaminophen use, and they’re significant enough, even
without the
risk of serious skin reactions or liver damage, that I do not recommend
taking this drug for minor aches and pains. Some of these include:
- Blood cancer
- Asthma, chronic obstructive pulmonary disease (COPD) and reduced lung function
- Brain damage
- Increased blood pressure
- Hearing loss
While I do not believe acetaminophen-containing drugs are appropriate
for minor aches and pains, given their significant risks, they are
sometimes necessary to suppress severe pain, such as while you are
recovering from an injury or surgery, or while you are seeking to
address the underlying cause of your pain. For those instances, make
sure you are also taking N-acetyl cysteine (NAC), which is the
rate-limiting nutrient for the formation of the intracellular
antioxidant glutathione.
It’s thought that Tylenol causes its damage by depleting glutathione,
an antioxidant that protects cells from toxins such as free radicals.
If you keep your glutathione levels up, the damage from the
acetaminophen may be largely preventable. This is why anyone who
overdoses on Tylenol receives large doses of NAC in the emergency room.
So whether you are taking Tylenol in prescription or over-the-counter
form, I strongly suggest taking NAC along with it.
Top Natural Tylenol Alternatives
Tylenol and related products are familiar household items for many, but they are
not the only option when you need relief from pain. For instance, the Emotional Freedom Technique (EFT) works very effectively for relieving headache pain. The Advanced Muscle Integration Technique (AMIT) helps treat muscle injuries and pain, while these simple exercises can work wonders for treating back pain.
No matter what your reason for taking Tylenol, type it into the
search box above and you’ll likely find a natural alternative. And if
chronic pain is your problem, the following options provide excellent
pain relief without any of the health hazards that acetaminophen and
other pain relievers carry:
- Astaxanthin: One of the most effective oil-soluble
antioxidants known. It has very potent anti-inflammatory properties and
in many cases works far more effectively than many NSAIDs. Higher doses
are typically required and one may need 8 mg or more per day to achieve
this benefit.
- K Laser: Laser
therapy treatment helps reduce pain and inflammation and enhances
tissue healing—both in hard and soft tissues, including muscles,
ligaments, and even bones. It increases oxygenation of tissues and
allows injured or damaged cells to absorb photons of light, which speeds
healing.
- Ginger: This herb is a potent anti-inflammatory and
offers pain relief and stomach-settling properties. Fresh ginger works
well steeped in boiling water as a tea or grated into vegetable juice.
- Curcumin: Curcumin
is the primary therapeutic compound identified in the spice turmeric.
In a study of osteoarthritis patients, those who added 200 mg of
curcumin a day to their treatment plan had reduced pain and increased
mobility. In fact, curcumin has been shown to have potent
anti-inflammatory activity, as well as demonstrating the ability in four
studies to reduce Tylenol-associated adverse health effects.
- Boswellia: Also known as boswellin or “Indian
frankincense,” this herb contains powerful anti-inflammatory properties,
which have been prized for thousands of years. This is one of my
personal favorites as I have seen it work well with many rheumatoid
arthritis patients.
- Cetyl Myristoleate (CMO): This oil, found in fish
and dairy butter, acts as a “joint lubricant” and an anti-inflammatory. I
have used this for myself to relieve ganglion cysts and a mild annoying
carpal tunnel syndrome that pops up when I type too much on
non-ergonomic keyboards. I used a topical preparation for this.
- Evening Primrose, Black Currant and Borage Oils: These contain the fatty acid gamma linolenic acid (GLA), which is useful for treating arthritic pain.
- Cayenne Cream: Also called capsaicin cream, this
spice comes from dried hot peppers. It alleviates pain by depleting the
body’s supply of substance P, a chemical component of nerve cells that
transmits pain signals to your brain.
- Therapeutic modalities such as yoga, acupuncture, meditation, hot and cold packs, and even holding hands can also result in astonishing pain relief without any drugs.