Parker Waichman LLP

Zonegran Linked to Blood Disorder

The epilepsy drug zonisamide, sold both generically and under the brand name Zonegran, can cause a serious blood disorder called metabolic acidosis, the Food & Drug Administration (FDA) warned today.  The agency said it is working with the makers of zonisamide to revise the product labeling to reflect this new risk. According to the FDA, […]

The epilepsy drug zonisamide, sold both generically and under the brand name <"https://www.yourlawyer.com/practice_areas/defective_drugs">Zonegran, can cause a serious blood disorder called metabolic acidosis, the Food & Drug Administration (FDA) warned today.  The agency said it is working with the makers of zonisamide to revise the product labeling to reflect this new risk.

According to the FDA, metabolic acidosis is a disturbance in the body’s acid-base balance that results in excessive acidity of the blood.  Metabolic acidosis can result in hyperventilation, and non-specific symptoms such as fatigue and anorexia, or more severe symptoms including cardiac arrhythmias or stupor.  Chronic metabolic acidosis can have adverse effects on the kidneys and on bones, and can retard growth in children.  

Patients with predisposing conditions or therapies, including renal disease, severe respiratory disorders, diarrhea, surgery, ketogenic diet, or certain other drugs may be at greater risk for developing metabolic acidosis following treatment with zonisamide.  The risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in pediatric patients, the FDA said.

According to a review of updated clinical data, the development of metabolic acidosis in patients taking Zonegran and generic equivalents generally appears to be dose-dependent and can occur at doses as low as 25 mg daily, the FDA said. Zonegran-induced metabolic acidosis generally occurs early in treatment, although it can occur at anytime.

The FDA has recommended  that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with Zonegran, even in the absence of symptoms. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran, and modifying the patient’s antiepileptic treatment as appropriate. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran, and modifying the patient’s antiepileptic treatment as appropriate.

If the decision is made to continue patients with metabolic acidosis on Zonegran, then alkali treatment should be considered, the FDA said.

Zonisamide is approved as an adjunct therapy to treat partial seizures in adults.  It is sold as Zonegran by Eisai Co Ltd, and in generic form by Teva Pharmaceutical Industries Ltd.,  Mylan Inc., Novartis AG’s  Sandoz unit and Watson Pharmaceuticals Inc.

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
I feel very grateful and happy with the service I received from the Parker Waichman LLP office. The process was very fast and effective. Thanks to Catherine Maryann and Jorge for helping me.Thank you
Hary Orellana
8 months ago
5 Star Reviews 150
Parker Waichman LLP were very compassionate with my case. Michele Josama was absolutely wonderful. She keep me very informed throughout the process. She was thorough and knowledgeable. Michele Josama is truly an asset to this firm.
Yesenia Bonilla
5 years ago
5 Star Reviews 150
Michele J at Parker waichman Was the best in helping me understand the process about the final stages of my dear fathers lawsuit settlement.mr Parker and mr waichman Michelle is extremely knowledgeable and a pleasure to deal with.my recommendation would to please let her know how thankful we are and we just wanted to let you know you definitely have a special lady working for your law firm .please let her know about my letter to you and again Michelle deserves recognition in her professionalism and knowledge.yours truly Steven Sica
Kelly Sica
4 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