Microbial Contaminant Control Problems at Ozempic Manufacturing Facility Has Resulted in FDA Investigator Warning

FDA inspectors found three occasions where “questionable organisms” were detected in batches of the active ingredient for Ozempic and similar drugs used for treatment of diabetes and weight loss

A recent inspection of a manufacturing plant that makes the active ingredient in Ozempic and Wegovy identified a serious a lack of adequate microbial controls, and unexplained discrepancies in manufacturing quality for the blockbuster diabetes and weight loss treatments.

The U.S. Food and Drug Administration (FDA) has cited Novo Nordisk’s Clayton, North Carolina facility, which makes semaglutide, for quality control problems following inspections conducted in July, according to a report by Fierce Pharma. Investigators expressed concern that these mistakes could result in microbial contamination, which may pose health risks for users.

The findings come at a time of rising health concerns over the potential side effects of the treatment, and as Novo Nordisk faces a growing number of Ozempic lawsuits and Wegovy lawsuits over severe stomach problems, known as gastroparesis or stomach paralysis.

Ozempic (semaglutide) was originally approved for the treatment of people with Type 2 diabetes. However, in recent years Ozempic has been increasingly prescribed for weight loss. Therefore, the drug maker introduced Wegovy, which contains the same active ingredient and is approved for weight loss, and both drugs have been aggressively marketed as safe and effective treatments.

The drugs are part of a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, which also includes Trulicity, Byetta and others. However, there is now increasing evidence of a serious risk of stomach problems from Ozempic, Wegovy and other members of the class, which can cause permanent delays in gastric emptying, leaving users with painful long-term gastrointestinal damage.

According to allegations raised in Ozempic stomach paralysis lawsuits filed in recent months, Novo Nordisk has placed a desire for profits before consumer safety, by promoting use of the drug for weight loss, without disclosing the risks users may face.

FDA Investigators Identified Problems at Ozempic, Wegovy Facility

The recent report by Fierce Pharma outlines findings from an FDA Form 483 inspection report, which the site was able to obtain. In it, FDA inspectors found “objectionable organisms” on three separate occasions in batches of semaglutide, which they say Novo Nordisk failed to properly investigate.

The FDA reportedly cited the facility for the failure to investigate and the failure to put in place adequate microbial contamination controls. Inspectors indicated Novo Nordisk had not established microbial limits for semaglutide being processed at the plant.

Microbial contamination could lead to infections and other adverse health consequences for consumers should those organisms be dangerous and if they were distributed to the public.

The Form 483 report has yet to be released to the public.

Ozempic and Wegovy Stomach Paralysis Lawsuits

In late June, the American Society of Anesthesiologists (ASA) issued new Ozempic and Wegovy surgery guidelines that warned against using the drugs before elective surgery, due to the risk of vomiting and aspiration during anesthesia. However, some anesthesiologists say the guidelines do not go far enough to protect patients.

Gastroparesis, also known as delayed gastric emptying or stomach paralysis, weakens the normal muscle movement in the stomach. These stomach contractions are necessary to push food through the digestive tract.

When gastroparesis occurs, the stomach is slow to empty, resulting in symptoms including nausea, vomiting undigested food, abdominal pain, abdominal bloating, severe dehydration, feeling full after only a few bites, undigested food hardening in the stomach, acid reflux, fluctuating blood sugar levels, lack of appetite, weight loss, malnutrition and decreased quality of life. However, some users are reporting these side effects persisted long after Wegovy or Ozempic are discontinued.

In July, a CNN investigation outlined an alarming number of reports linking Ozempic and stomach paralysis, indicating that similar problems have been associated with other drugs in the same class in recent years.

In 2017, researchers with the Mayo Clinic conducted a study involving a similar diabetes medication known as Victoza, which found that the drug caused significantly slower digestion in users, taking about 70 minutes for half the food they ate to leave their stomachs, compared to four minutes for people who did not take the drug. However, the study found that people’s bodies tended to adjust over time.

The first known Ozempic gastroparesis lawsuit was filed in early August, alleging Novo Nordisk knew about the risks, but failed to provide patients and healthcare providers with adequate warning. It was the first of what could be hundreds or thousands of such lawsuits filed in the coming months and years.