Tightened Specs for Levothyroxine
The FDA is acting to ensure that thyroid medications do not lose their potency prior to the products' expiration date. The agency is mandating that levothyroxine drug products tighten their potency specifications to meet a 95% to 105% potency specification until their expiration date. This will ensure that the drug will not degrade by more than 5% of the labeled claim before the expiration date and will also address occasional analytical testing variability. The products are currently allowed a potency range of 90% to 110%.
This action aims to address concerns about levothyroxine products that have been raised by healthcare practitioners and patients. The change was recommended by a joint FDA advisory committee. Manufacturers and marketers have 2 years to comply with the new specification.
The change will help ensure that patients receive the appropriate level of drug therapy needed for their thyroid conditions. The FDA notes that the new specifications also will reduce stability profile variability between products that could have clinical consequences for achieving target thyroid levels, especially for vulnerable patients, such as those with thyroid cancer.
Expanded Age Range for Menactra
The FDA expanded the approved age range for the bacterial meningitis vaccination Menactra to include children ages 2 to 10 years. Previously, the vaccine was approved for people ages 11 to 55 years of age.
Prior to this approval, the only bacterial meningitis vaccine approved for use in children 2 to 10 years old was Menomune. Both Menomune and Menactra are products of Sanofi Pasteur Inc. Both vaccines offer protection against four groups of Neisseria meningitidis bacteria, which can cause meningitis.
Bacterial meningitis vaccinations are recommended for children ages 2 to 10 years who are at increased risk of developing meningococcal disease, such as those who have had their spleens removed or whose spleen is not functioning and those who plan to travel outside the United States in areas where the disease is common.
Storage Condition Change for Humate-P
The FDA approved a change in the storage conditions for Humate-P. Humate-P can now be safely stored for up to 2 years at 77[degrees]F. Previously, the product required colder, refrigeration-level temperatures for that length of storage.
Humate-P is approved for the treatment and prevention of bleeding in adult patients with hemophilia A, the treatment of spontaneous and trauma-induced bleeding, and prevention of excessive bleeding related to surgery in adult and pediatric patients with von Willebrand disease.
Humate-P is made from human plasma obtained from screened and tested U.S. donors.
Approval of the change was based on new study data about product stability and product potency conducted by the manufacturer.
Possible Exenatide, Pancreatitis Link
Data from postmarketing reports in exenatide (Byetta)-treated patients suggest a possible link between the medication and a risk of acute pancreatitis. The FDA notes that most of the patients had at least one additional risk factor for the condition such as gallstones, severe hypertriglyceridemia, and alcohol use. In some cases, pancreatitis symptoms corresponded with increases in twice-daily dosing from 5 to 10 micrograms.
While the role of exenatide remains unclear, 73% of patients improved after discontinuing therapy.
Healthcare professionals are advised to be alert for signs and symptoms of acute pancreatitis and to instruct patients to seek prompt medical care for unexplained persistent abdominal pain with or without vomiting. Treatment should be discontinued if pancreatitis is suspected and permanently discontinued upon diagnostic confirmation unless another cause is found.