Pharmacy News: Varenicline and Statins

November-December 2021

pill bottles

Voluntary Recall of Varenicline (Chantix) Due to Nitrosamine

The Department of Health Care Services (DHCS) releases monthly Drug Utilization Review (DUR) articles which provide timely and relevant information on drug-specific therapy issues.

Varenicline is an FDA-approved medication indicated to assist adults to quit smoking. On September 17, 2021, the U.S. Food and Drug Administration (FDA) announced a voluntary manufacturer recall of all varenicline 0.5 mg and 1 mg tablets due to levels of nitrosamine impurity. 

Long term use of nitrosamine is associated with a potential increased risk of cancer. The FDA recommends for patients currently taking varenicline to continue therapy until a replacement or alternative medication is provided because the benefits for stopping smoking outweigh the increased cancer risk from nitrosamine impurity. 

Health care professionals should consider other available treatment options for patients currently taking varenicline and quarantine any varenicline samples for proper disposal.

FDA Requests Removal of Pregnancy Contraindication for Statins 

Statins are commonly used for preventing and treating the build-up of fats, cholesterol, and other substances in and on the artery walls (atherosclerosis) and have been shown to reduce the incidence of heart attacks, strokes, and death. 

On July 20, 2021, the U.S. Food and Drug Administration (FDA) announced it is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. 

Despite this change, the FDA still recommends that most patients stop statins once they learn they are pregnant. In addition, patients should not breastfeed when taking a statin because the medicine may pass into breast milk and pose a risk to the baby. 

Although many patients should be able to stop statins temporarily until breastfeeding ends, patients who are at high risk of heart attack or stroke who require statins after giving birth should not breastfeed and should use alternatives such as infant formula. 

Statins are safe to prescribe in patients who are not pregnant but may become pregnant and unintended exposure to statins in early pregnancy is unlikely to cause harm to the developing fetus. Published data from prospective and retrospective observational cohort studies with statin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage. 

Report side effects involving statins or other medications to the FDA MedWatch program. 

To read the full safety announcement, which includes a summary of the studies reviewed by the FDA, refer to the article found on the Drug Safety and Availability page of the FDA website.