FDA Documents Reveal Potential Risk of Intestinal Obstruction with GLP-1 Drugs, Sparking Legal Concerns
Serious Warning Issued to Drug Manufacturers Following Levensten Law Firm FOIA Request
The Levensten Law Firm, through its diligent use of the Freedom of Information Act (FOIA), has acquired internal FDA documents raising concerns about the safety of popular GLP-1 drugs like Ozempic, Rybelsus, Victoza, Tulicity, and Mounjaro. These documents reveal a potential link between these blockbuster medications and a serious risk of intestinal obstruction, a potentially life-threatening condition.
FOIA Documents Highlight Key Findings:
- June 2022: The FDA alerted manufacturers of GLP-1 drugs about their analysis suggesting a safety signal for intestinal obstruction associated with their products.
- September 2022: The FDA mandated a label change for these drugs, requiring a warning for “Gastrointestinal: ileus” (a form of intestinal obstruction).
- November 2022: An FDA Pharmacovigilance Review, obtained by the Levensten Law Firm, deemed the evidence sufficient to support an association between GLP-1 drugs and increased risk of intestinal obstruction, further solidifying the need for a label change.
Links to Obtained Documents:
To ensure transparency and public awareness, The Levensten Law Firm provides direct access to the relevant FOIA documents:
- FDA email to GLP-1 makers confirming risk: https://www.dropbox.com/s/gak9imkc80v0jbc/23002845_enc3_sdm.pdf?dl=0
- FDA correspondence to GLP-1 makers requiring label change: https://www.dropbox.com/s/jvcl4qryfmfrgez/23002845_enc2_sdm.pdf?dl=0
- FDA Pharmacovigilance Review of GLP-1 drugs dated November 2022 confirming risk: https://www.dropbox.com/s/4wan1kgyog5t40v/23002845_enc1_sdm.pdf?dl=0
Potential Legal Implications and Resources for Affected Individuals
Studies further suggest a link between these drugs and other serious adverse events, including gallbladder disease. The Levensten Law Firm encourages anyone who has experienced concerning side effects after taking Ozempic, Rybelsus, Victoza, Tulicity, or Mounjaro, such as intestinal obstruction or acute gallbladder disease, to contact us at 215-545-5600.
Our compassionate and experienced legal team can provide confidential guidance and answer any questions you may have about your legal rights and options. Don’t hesitate to reach out if you or someone you know has been impacted by these potentially dangerous medications.