Popular Cold Medicine Contains Cancer-Causing Benzene

According to a recent analysis by Bloomberg, generic store-brand versions of Mucinex, a popular cold medicine containing guaifenesin that is used by millions of Americans during cold and flu season, have been found to contain benzene. A cancer-causing chemical linked to leukemia and other serious blood disorders, benzene is the same carcinogenic compound found in some conventional sunscreen and beauty products. Benzene was detected in carbomer, an inactive ingredient used in the generic store-brand versions of Mucinex.¹

The brand-name Mucinex was not found to contain benzene in its carbomer. However, many Americans opt for generic store-brand drugs to save money.  The generic versions of Mucinex, which are sold at CVS, Walmart, Walgreens and Target, were sourced from New Jersey-based Amneal Pharmaceuticals.

An Amneal spokesperson said in a statement:

Patient safety has always been Amneal’s highest priority, underscored by our decades-long track record of industry-leading quality. Our guaifenesin products are manufactured in accordance with all FDA prescribed limits as well as more stringent company limits.¹

Guaifenesin is an expectorant that helps loosen and thin mucus in the airways, making it easier to cough up and clear from the respiratory tract.

Amneal officials also stated that it sources carbomers from “the world’s largest and most trusted manufacturer that also supplies for most branded products,” ensuring regular quality testing of incoming materials. The company representative added that the company “immediately began reformulating these products upon publication of FDA’s reformulation guidance.”

Amneal officials say they are also conducting the necessary FDA-required testing and plan to submit the reformulated generic cold medicine products to the FDA by the end of 2024. “We expect to bring these products to market in advance of the FDA’s August 2025 deadline.”¹

Benzene Contamination Raises Concerns a Year After Phenylephrine Declared Ineffective

Bloomberg’s report of benzene in drugstore versions of one of the most popular cold medicines comes almost a year after the U.S. Food and Drug Administration (FDA) ruled that phenylephrine, a common active ingredient in decongestants like Dayquil, Mucinex, Sudafed and others, is ineffective and does not work as advertised. These products, which popular drug stores like CVS vowed to remove from shelves, comprise four-fifths of the $2.2 billion oral decongestants market.²

CVS also issued a statement in light of the findings. “Our store brand products are developed to be safe and high-quality, work as intended, comply with regulations, and satisfy customers.” CVS officials said they require all suppliers to “comply with all laws and regulations and are committed to following the FDA’s guidance.”¹ “When setting up any drug or cosmetic product, CVS store brand suppliers are required to certify that neither their raw material nor finished product contain benzene,” the statement continued.

Benzene Detected in Spray Sunscreens and Other Beauty Products

Certain aerosol sunscreens along with lotions, gels, and other beauty products have also been found to be contaminated with benzene. The Environmental Working Group (EWG) stated, “Many of the sunscreens with the highest levels of contamination have either been recalled or removed from store shelves, but this kind of reactive recall does not prevent harm to consumers who have already used these products.”

U.S. government regulators do not require sunscreen contamination tests that may protect American consumers from possible health risks.³

Walgreens Faces Class-Action Lawsuit Over Benzene-Containing Cold Medicine

Walgreens is now facing a proposed class action lawsuit from customers who claim they were not informed that the store’s generic Mucinex contains benzene, a cancer-causing chemical. Filed on Sept. 4, 2024, in federal court in Chicago, the lawsuit alleges that Walgreens failed to label the product or warn consumers about the carcinogen.

U.S. regulators have permitted the use of benzene by drug makers for decades.⁴

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