Recent Drug Approval Highlights Less Stringent FDA Criteria

judge medication abortion
Text FDA Approved typed on retro typewriter

The FDA’s March approval of Noctiva (desmopressin) is an example of the agency approving a drug where the risks outweigh the benefits, two physicians argue.

Noctiva was approved to treat nocturia, a condition characterized by frequently waking up in the middle of the night to urinate. Michael Fralick, MD, and Aaron S. Kesselheim, MD, say that nocturia is a symptom rather than a disease, and nocturia itself can be a side effect of a medication or an indication of a more significant health problem.

Writing in a JAMA op-ed piece, Fralick and Kesselheim, who are both affiliated with Brigham and Women’s Hospital and Harvard Medical School in Boston, note that the benefit of desmopressin was moderate. Yet, the drug was approved with a “black box” warning — the most severe the FDA can require — on potentially life-threatening hyponatremia, a condition where the sodium level in the blood is too low, leading to swelling in cells.

Incidentally, desmopressin is not a new drug at all. It was approved back in the 1970s to treat bedwetting in children.

Desmopressin was tested in several clinical trials. In 2 of them, Fralick and Kesselheim say that the drug failed to work in terms of reducing the number of trips to the bathroom. In 2 other trials, they noted that researchers excluded many patients the drug would likely be used on, including those with diabetes, congestive heart failure, poor kidney functioning or hyponatremia.

“It is becoming increasingly important for physicians to critically examine the underlying data and communicate the totality of the expected benefits to patients,” the pair wrote.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

Was This Article Helpful?

Show Comments (0)
0 0 votes
Article Rating
Notify of
Inline Feedbacks
View all comments
Would love your thoughts, please comment.x