Parker Waichman LLP

Tussionex Death Report Prompt New Warnings from FDA

Tussionex Death Reports. Tussionex, a prescription cough medicine manufactured by UCB SA, has been linked to numerous side effects and some deaths, and the Food and Drug Administration (FDA) is said to be considering issuing a public warning for Tussionex. UCB SA, a Belgian company, recently contacted the FDA about updating safety information on the […]

Tussionex Warning

Tussionex Death Reports. Tussionex, a prescription cough medicine manufactured by UCB SA, has been linked to numerous side effects and some deaths, and the Food and Drug Administration (FDA) is said to be considering issuing a public warning for Tussionex.

UCB SA, a Belgian company, recently contacted the FDA about updating safety information on the Tussionex label regarding proper dosage.

Tussionex, sold as ‘Tussionex’ Pennkinetic Extended-Release Suspension, is one of eight prescription cough medicines that contain the narcotic pain reliever hydrocodone. Hydrocodone is habit-forming, and can lead to physical and psychological addiction. A hydrocodone overdose is possible when too much of the drug is used. An overdose of hydrocodone can be fatal.

Five deaths have been reported among children under 6 who took Tussionex since its approval in 1987.   ‘Tussionex’ has only been approved for adults and children over 6. The ‘Tussionex’ label says specifically that the drug is not intended for use in children under 6, but the reports of pediatric deaths suggest that those warnings are inadequate.

Additional Warnings for Tussionex

On Friday, The Wall Street Journal reported that the FDA was considering additional warnings for Tussionex. When those warnings might be coming is unknown, but the Journal article said the FDA decided on the course of action after receiving numerous reports of adverse events including some deaths related to ‘Tussionex’. The Journal said the FDA had received reports of patients taking higher doses or more frequent doses than recommended.

A spokesman for UCB SA told Reuters that Tussionex is “safe and effective” when directed. However, reports of deaths and other reactions tied to ‘Tussionex’ had prompted the company to approach the FDA about adding additional safety warnings to the drug.

Tussionex is not the only cough medicine that has raised concerns because of dangers posed to children.  In January, the FDA issued a warning that such medicines should not be given to children under two. The FDA is still reviewing these medications for use in older children, and could provide further guidance in the coming months.

In fact, in a preemptive move, the manufacturers of some infant over-the-counter cold medicines chose to recall the products this past October. Among the over-the-counter medications coming off the market are Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand.

Pediacare, Dimetapp and Little Colds brand products were also recalled.   In the January public health advisory, the FDA praised the manufacturers of these products for the move to take them off the market.

Need Legal Help Regarding Tussionex?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

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
Christina (Tina) Morace is wonderful and so very helpful!!!
Margaret Evers
a year ago
5 Star Reviews 150
They were really professional answered all my questions walk me through the end of my case i will surely recomend to my family and friends
Malini Prasad
6 months ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value My overall experience with PW has been excellent. Benita was very helpful and professional throughout the process. Would definitely recommend this law firm to all
Arnold Musella
2 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