Parker Waichman LLP

FDA Meets On Acetaminophen

In addition to other suggestions, U.S. health advisers recommended yesterday that the maximum dose of over-the-counter (OTC) acetaminophen, be lowered. Exceeding recommended acetaminophen dosages could increase risks for severe liver damage. In 1977, the U.S. Food & Drug Administration (FDA)—which has long been struggling with OTC acetaminophen use and overuse—wanted labels issued to indicate the […]

In addition to other suggestions, U.S. health advisers recommended yesterday that the maximum dose of <"https://www.yourlawyer.com/practice_areas/defective_drugs">over-the-counter (OTC) acetaminophen, be lowered.

Exceeding recommended acetaminophen dosages could increase risks for severe liver damage. In 1977, the U.S. Food & Drug Administration (FDA)—which has long been struggling with OTC acetaminophen use and overuse—wanted labels issued to indicate the potential liver damage that can occur when acetaminophen is not used correctly, explained Dow Jones previously. According to a prior FDA statement, safety data reported in medical literature indicates that people sometimes take more acetaminophen than labeling recommends. Others unknowingly take multiple products containing acetaminophen concurrently.

This week’s vote followed last month’s FDA report that concluded severe liver damage and death could occur due to a lack of consumer awareness about acetaminophen, said HealthDay News. Educational campaigns do not appear to have had an impact in lowering liver failure in this country, said the FDA, according to the Associated Press (AP. Consumers often mistakenly believe more is better without understanding the serious risks associated with misuse, noted HealthDay News, adding that consumers are not fully aware of how ubiquitous the medication is in other drugs, which can contribute to overdosing.

Although the FDA has sponsored consumer education campaigns for over five years, said HealthDay News, “recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur,” citing the FDA report.

In addition to a recently mandated labeling change, federal regulators—in an attempt at reducing acetaminophen-related liver damage—looked at a number of choices, such as reducing dosing levels, eliminating medicines that combine acetaminophen with other ingredients, reducing the quantity of acetaminophen in drugs that contain the medication, or strengthening prescription drug labeling, said Dow Jones previously.

Yesterday, said the AP, the FDA panel voted 21-16 to lower current maximum dosages of OTC acetaminophen, currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. The group agreed (24-13) on a maximum single dose of 650 milligrams, a drop in, for instance, the current single dose of Extra-Strength Tylenol, which is 1,000 milligrams for two tablets, said the AP, citing the group as saying the current dose should be available by prescription only.

The panel also voted 24-13 to keep other OTC products containing acetaminophen—cough and cold products, for example—on the market, citing lower overdose rates with these products, said the AP. The FDA panel also voted 20-17 that prescription drugs combining acetaminophen with other painkillers be eliminated and voted—36-1—to include a black box warning—the agency’s strongest—if the drugs remain on the market, said the AP.

Acetaminophen is, said Dow Jones, the most “widely used drug in America,” and is found in OTC painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name just some and is used in combination with powerful prescription medications such as Vicodin and Percocet. While the FDA says acetaminophen is safe when taken at recommended levels, the problem is the medication’s pervasiveness, which can lead to one patient taking a number of acetaminophen-containing medications at the same time, noted Dow Jones, an issue since the 1970s.

Although panel votes do not require acceptance by the agency, the FDA generally complies with panel findings.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Very professional, punctual ,kept me in the loop on everything,helped explain and assist in filling out paperwork.
kevin v
6 years ago
5 Star Reviews 150
I couldn’t say more good things about Daniel Burke. He was there every moment that I needed him. Thank you so very much for all that you did.
Edgar Poole
7 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Value I want to say thank you to Kathy Snedecore for her awesome work ethics. She’s amazing and I appreciate her always providing updates and being on top of my Mother’s case. Thank you for everything! Me & Leyla are beyond grateful.
Gabriela Fernandez
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038