Parker Waichman LLP

FDA Panel Votes To Eliminate Two Popular Painkillers

A government panel voted that two popular prescription painkillers be taken off of the market because of their alleged impact in dangerous, sometimes fatal, overdoses. The Associated Press reported that Vicodin and Percocet, which are combined with the popular medication acetaminophen, should be removed because of issues linked with acetaminophen, a component in a variety […]

A government panel voted that two popular <"https://www.yourlawyer.com/practice_areas/defective_drugs">prescription painkillers be taken off of the market because of their alleged impact in dangerous, sometimes fatal, overdoses. The Associated Press reported that Vicodin and Percocet, which are combined with the popular medication acetaminophen, should be removed because of issues linked with acetaminophen, a component in a variety of other common medications.

Acetaminophen is, said Dow Jones previously, the most “widely used drug in America” and is found in over-the-counter (OTC) painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name just some. Acetaminophen is also used in combination with powerful prescription medications such as Vicodin and Percocet.

According to Dow Jones, approximately 100 people die annually from accidental acetaminophen overdoses. And, while the U.S. Food & Drug Administration (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.

Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. In 1977, the 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. 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. Alcohol use can increase the risk of liver damage with acetaminophen, the agency noted.

Yesterday, said the AP, an FDA panel voted 20-17 that prescription drugs combining acetaminophen with other painkillers be eliminated. 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 each drug that contains the medication, or strengthening prescription drug labeling for medications containing the drug to include strong language about liver risks, said Dow Jones previously.

Educational campaigns do not appear to have had an impact in lowering liver failure in this country, said the FDA, according to the AP, citing FDA data that notes most—60 percent—of acetaminophen-related fatalities are linked to prescription medications.

The group also voted—36-1—to include a black box warning if the drugs remain on the market, said the AP. A black box is the agency’s strongest warning. The group also voted 21-16 to lower current maximum dosages of OTC acetaminophen, which is currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. In another vote—24-13—the group agreed 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 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.

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

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
Parker Waichman handled the case for my dad who had bed sores.The team was very professional.The paralegal Michele Josama who was assigned to the case was an absolute pleasure to deal with.She was always so helpful in every way.Her patience and kindness was outstanding.Michael Zaransky the attorney on the case was very attentive to all our requests and delivered a result that we were very pleased with.Parker Waichman will certainly be recommended to anyone I know that needs legal assistance!!
richard nissenbaum
5 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value They settled a personal injury case for me very much to my satisfaction. I really want to thank my paralegal, Kathy Snedecor, for all her assistance. She was the one who stayed on top of things and tirelessly helped me through this tumultuous process.
Frank Borgi
3 years ago
5 Star Reviews 150
Positive: Professionalism , Responsiveness I am very happy with the services provided by this firm. They were very professional and responsive to my needs and concerns.
Kristan David Curry
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