“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.
Warning Added to Thyroid Drug Label
Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.
The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning 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.”
PTU was approved in 1947 for the treatment of hyperthyroidism.
The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”
The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.
There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.
Rules for Home Use Strengthened
Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.
The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.
The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.
Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.
About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.
The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.