If You Use This Medication, Talk to Your Doctor Immediately, FDA Says
This commonly prescribed medication could present a serious risk to your health, the authority says.
For many people battling an illness or condition, medication is the first step toward improving their day-to-day life. Unfortunately, anyone seeking better health through the use of a popular Pfizer prescription medication may be in for a rude awakening, now that multiple lots of the drug are being pulled from the market over safety concerns. Read on to discover if your medication is part of the recall, and find out what to do if you've got the affected drugs at home.
Pfizer has recalled specific lots of Chantix.
On July 19, the U.S. Food & Drug Administration (FDA) announced that Pfizer had voluntarily recalled multiple lots of smoking cessation medication Chantix. The affected medications include the following: 56-count bottles of Chantix 0.5 mg tablets with lot number 00019213 and expiration date Jan. 2022; 56-count bottles of Chantix 0.5 mg tablets with lot number EC6994 and expiration date May 2023; 56-count bottles of Chantix 1 mg tablets with lot number EA6080 and expiration date March 2023 ;56-count bottles of Chantix 1 mg tablets with lot number EC9843 and expiration date March 2023; and eight lots of Chantix cartons containing one blister pack of 0.5 mg tablets and one blister pack of 1 mg tablets with lot number 00020231 and a Sept. 2021 expiration date; lot number 00020232 and a Nov. 2021 expiration date; lot number 00020357 and a Dec. 2021 expiration date; lot number 00020358 and a Jan. 2022 expiration date; lot number 00020716 and a Jan. 2022 expiration date; lot number ET1600 and a Jan. 2023 expiration date; lot number ET1607 and a Jan. 2023 expiration date; and lot number ET1609 and a Jan. 2023 expiration date.
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The medication may contain an ingredient that could increase cancer risk.
The affected lots of Chantix are being pulled from the market after it was discovered that they may contain levels of N-nitroso-varenicline, a type of nitrosamine, that exceed the Acceptable Daily Intake (ADI) level set by Pfizer.
"Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication," the recall notice states, noting that Chantix is generally used in the short-term for smoking cessation to begin with.
Continuing the medication may outweigh the risk of taking it.
Pfizer explains that, at the time the recall notice was issued, there had been no adverse health outcomes associated with use of the recalled medications.
In fact, the company says that smoking is more dangerous than the ingredient being called into question. "The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines," Pfizer said in its recall announcement.
If you have the affected medication at home, contact your doctor.
If you have any of the affected lots of Chantix at home, contact your doctor to decide on the course of action that's best for you, whether that means getting a new package of the medication or changing your course of treatment. You should also contact Stericycle Inc. at 888-276-6166 (available on weekdays from 8 a.m. to 5 p.m.) for information on how to return the medication and get a refund.