The Safety of Prescription Drugs
- Pfizer is suspending distribution of its popular anti-smoking drug Chantix due to concerns about the level of carcinogen NDMA found in some lots of the pills.
- The Food and Drug Administration has not issued a recall on Chantix. Health authorities in Canada recalled the drug, sold under the name Champix, June 8.
- This is the latest in a recent string of issues with drugs potentially containing high levels of NDMA. In June 2020, the FDA asked companies to recall the popular diabetes drug metformin due to an apparent cancer risk.
The FDA approved the drug in May 2006 to help adults age 18 and over quit smoking, which remains the number one risk factor for developing lung cancer. The medication is typically used for 12 to 24 weeks.
Read MoreThe Food and Drug Administration has not issued a recall on Chantix. Health authorities in Canada recalled the drug, sold under the name Champix, June 8.
In June 2020, the FDA asked companies to recall the popular diabetes drug metformin due to an apparent cancer risk. The agency said that a high level of NDMA was found in several batches of the extended-release form of the drug, which is often prescribed to control high blood sugar in patients with type 2 diabetes. NDMA contamination was also responsible for the recall of heartburn drug Zantac sold by Sanofi SA in 2019.
What is NDMA?
NDMA is a chemical that can be unintentionally formed during various manufacturing processes, according to the Centers for Disease Control and Prevention (CDC). People can be exposed to low levels of NDMA in a variety of ways it can be found in foods like cured meats and fish, beer, tobacco smoke and even in some toiletry and cosmetic products. NDMA is labeled as a “probable carcinogen,” meaning it may cause cancer in humans.
Essentially, NDMA is all around us at low levels. When it comes to cancer risk, it’s difficult for medical professionals to say exactly how dangerous the substance is.
“We don't really know long term exactly what the risk is… we do know that there is some potential for cancer and liver issues,” Dr. Tan says.
The FDA considers the chemical generally safe as long as exposure does not exceed a certain limit and people are not exposed for a long period of time.
To avoid potential dangers, the FDA regularly tests and monitors products like medications to ensure that they only contain what the agency considers to be safe levels of contaminants like NDMA. The metformin recall in June 2020 came after the agency determined that the extended-release form of the drug had NDMA levels that were above the FDA’s “acceptable intake limit.”
The acceptable intake limit for NDMA is 96 nanograms per day for medications, according to the FDA.
Contributing: Laura Gesualdi-Gilmore
Learn more about SurvivorNet's rigorous medical review process.
