FDA Slaps Black Box Warning on Hyperthyroidism Drug for Causing Severe Liver Damage

By May 20, 2010 July 9th, 2019 Uncategorized

About a year ago, I wrote about the U.S. Food and Drug Administration’s warning to healthcare providers about the risk of serious liver damage and failure in patients using propylthiouracil, a treatment for overactive thyroid. The FDA recently cautioned that this drug carries an even greater risk than had previously been thought and added a black box warning. The agency determined that a black box warning was warranted after receiving 32 adverse event reports, including 12 deaths and 12 liver transplants between 1969 and 2009. Even though these adverse events took place over the course of 40 years, the FDA decided that the events were serious enough that the public needed to be warned. As a defective medication lawyer, I applaud the FDA for helping to protect patients from unnecessary risks.
Propylthiouracil has been one of several available treatments for Graves’ disease and other varieties of hyperthyroidism, which involves the overproduction of the hormone thyroxine. Hyperthyroidism is quite treatable and not usually life-threatening — but from the FDA’s finding, it appears that the treatment can be worse than the disease. While patients are advised not to stop taking propylthiouracil unless they are instructed to do so by their doctors, the FDA warns that because of the severity of the adverse effects they have seen associated with this drug, propylthiouracil should only be used by patients who are unable to use other approved treatments for hyperthyroidism. The other approved treatments include another drug called methimazole, radioactive iodine and surgery. Because methimazole is associated with increased likelihood of birth defects, propylthiouracil is actually recommended for hyperthyroidism patients in or before the first trimester of pregnancy.
Propylthiouracil is especially dangerous for children, and as of last year, 40% of children being treated for Graves’ disease were receiving this drug. For all patients, the FDA recommends that propylthiouracil should be the last treatment that a patient tries, and patients who do take it are to receive a Medication Guide explaining the risks, as part of a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. Patients taking the drug are advised to contact their doctors if they experience signs of liver injury, like fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark-colored urine or yellowing of their skin or eyes.
As a defective drug lawyer, I wonder when the manufacturers of propylthiouracil began to realize that the drug had the potential to cause serious liver injury. The drug’s effects have been tracked for 40 years, so it’s unlikely that the FDA’s black box warning has come as a big surprise. Perhaps since the drug is available only from generic manufacturers, none of these manufacturers felt that it was their responsibility to warn the FDA and patients of the seriousness of these risks. Speaking as a pharmaceutical liability attorney, I hope that this is not the case, since the law mandates that drug manufacturers warn consumers and the FDA about risks involved with their products.


If drug manufacturers knew of the risks and chose not to warn the public, prioritizing their image and profits above patients’ lives and health, patients who were harmed have the right to recover compensation from the drug manufacturers. That means that a patient who suffers liver failure can sue to have his or her medical costs paid for, as well as pain and suffering, lost income, and lost quality of life. Relatives of someone who was killed by a defective drug may also hold the drug manufacturer responsible. Patients with an easily treated disorder like hyperthyroidism do not expect to emerge from their treatment needing a liver transplant. If patients are harmed by their thyroid medication to that degree, state law recognizes that they should not also bear all the costs associated with the injury that was inflicted on them. Carey, Danis & Lowe helps people who have been hurt by dangerous drugs. If you or someone you love has been seriously harmed by a prescription or over-the-counter medication, please meet with one of our attorneys experienced in recovering compensation from the company that caused your injury.
If you have been hurt by a defective medication, please call the Lowe Law Firm for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.