FDA Recalls PTSD Drug Over Cancer Risk Concerns

A drug commonly prescribed to veterans suffering from post-traumatic stress disorder nightmares has been recalled due to concerns over cancer risk. The Food and Drug Administration has recalled half a million bottles of Prazosin, which is typically used to lower blood pressure but also prescribed for PTSD-related nightmares.

The recall affects 100-pill bottles distributed by Teva Pharmaceuticals USA and 20-pill cartons from Amerisource Health Services LLC. According to FDA notices, tests found nitrosamine impurities in these batches that exceed acceptable intake limits and could potentially be cancer-causing.

Pete Kasperowicz, a spokesperson for the Department of Veterans Affairs, stated that the agency has ceased distributing the affected batches and is working to inform veterans about the recall. However, VA officials did not disclose how many veterans might be impacted by this recall, whether for PTSD or blood pressure treatment.

PTSD diagnoses are notably prevalent among VA patients. In fiscal year 2024, nearly 2.2 million of the 5.8 million veterans served by the VA health system were diagnosed with PTSD, affecting approximately 14 percent of men and 24 percent of women.

Research indicates that around 15 percent of veterans, roughly one in six, experience trauma-related nightmares. Jess Calohan, a psychiatric-mental health nurse practitioner who treats veterans and prescribes Prazosin, explained that this drug is widely utilized within the VA.

Calohan, a combat veteran himself, has conducted research on Prazosin as a treatment for soldiers suffering from trauma nightmares. This research led to Prazosin's inclusion in the Department of Veterans Affairs and Department of Defense's Clinical Practice Guidelines for drug interventions for PTSD.

Calohan emphasized that he prescribes Prazosin primarily for patients whose PTSD significantly impacts their sleep, causing them to wake multiple times or struggle to fall back asleep. He noted that pharmacies are often the main source of information about drug supply issues, including recalls.

While there is no formal obligation to notify patients about recalls, he highlighted the importance of this communication for maintaining trust between patients and healthcare providers. Calohan expressed concern that many patients might be unaware of this recall, suggesting that once information spreads, patients can take proactive steps to consult their providers and pharmacies regarding their medication.

The FDA's recall of Prazosin highlights the critical need for ongoing monitoring of medication safety, especially for treatments addressing mental health conditions such as PTSD.