Propylthiouracil Side Effect: Liver Injury

Propylthiouracil Side Effects Lawsuits

Propylthiouracil Side Effects Injury Lawsuits. Propylthiouracil, a drug used to treat an overactive thyroid or Graves’ disease, has been associated with severe liver injuries in both adults and children. In April 2010, the U.S. Food & Drug Administration (FDA) decided that because the liver injury risk from propylthiouracil was so great, a boxed warning […]

FDA Boxed Warning on Propylthiouracil

Propylthiouracil was first approved in 1947. It is a second line treatment for overactive thyroid and Graves’ disease for patients who are allergic to or intolerant of methimazole. It is also used to treat overactive thyroid and Graves’ disease in pregnant women, as methimazole has been associated with rare cases of birth defects when used in pregnancy.

According to the FDA, from 1969 to June 2009, it has received reports of 34 cases of severe liver injury associated with propylthiouracil. Twenty-three cases were in adult patients and 11 were in pediatric patients. Of the 23 adult cases, 13 deaths and five liver transplants were reported. Among the 11 pediatric cases, two cases resulted in death and seven patients required a liver transplant; one patient died while on the transplant list.

Meanwhile, in patients treated with methimazole, only five cases of serious liver injury were identified. All five cases were in adult patients and three resulted in death.

Based on these findings, and a review of the medical literature, the agency concluded that use of propylthiouracil is associated with a higher risk for clinically serious or fatal liver injury compared to methimazole in both adult and pediatric patients.

The new boxed warning states that for patients being started on treatment for hyperthyroidism it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine or surgery. In addition, due to the occurrence of birth defects that have been observed with the use of methimazole during the first trimester of pregnancy, propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.

To help patients understand the known benefits and potential risks of propylthiouracil, as part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA is also requiring that a Medication Guide be given to every patient filling a prescription for propylthiouracil.

Finally, the FDA is also advising healthcare providers that propylthiouracil is not recommended for use in pediatric patients, except in rare instances in which other alternative treatments are not appropriate.

Propylthiouracil Liver Injury Lawsuit Consultation

The liver injuries caused by propylthiouracil are extremely painful and traumatic, especially when they occur in children. The propylthiouracil liver injury lawyers at our firm are working to do everything legally possible to make sure victims of this dangerous drug receive the justice they deserve.

Need Legal Help Regarding Propylthiouracil Side Effects?

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).

Parker Waichman is a great law firm and most of all they treat you like more than just a client .I was dealing with another law firm prior to dealing with Parker Waichman and they never returned my calls and treated me like a burden rather than a client. But all of that changed when I came to this firm they always call me back and never make me feel as though I am a burden . They also work very hard for there clients and give you constant updates on how your case is going . I have sent family members of mines to them knowing that they will have the same care and compassion for them as they had for me.

Michelle Curry

9 years ago

I’m really satisfied with my experience dealing with Parker and Waichman and especially my attorney, Mathew Hinrichs, along with the support staff (Jacqueline & Theresa). My attorney is very professional and thorough but very approachable. He always returns calls/emails even in the early evening if necessary. His support staff of Paralegals are professional and thorough as well. This law firm gets things done! My confidence in Parker Waichman is very high, and I have been recommending this law firm to others here in Milwaukee by word of mouth. This recommendation will continue.

Daniel Kasten

3 years ago

On the Christmas Eve of 2015 I had a car accident I felt lost and confused. I had no idea what I was going to do or how I was going to get my car fixed. My supervisor referred me Jorge Peniche who works for Parker Waichman. He came to meet me at my house the same day I spoke to him and helped me till the end of my case. I was very pleased with the lawyers and Jillian was very helpful in the process, her and Jorge were ready to answer any of my questions. Thank you Parker and Waichman!!

Fanta Jondot

5 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.