The US Food and Drug Administration (FDA) has just introduced guidelines aimed at expediting the reformulation of drug products that incorporate inactive ingredients manufactured with benzene, a recognized carcinogen. These guidelines encompass new drug applications, abbreviated new drug applications (ANDAs), marketed drugs, and nonprescription drugs, including various dosage forms such as creams, gels, lotions, ointments, oral suspensions, and solid oral dosage forms.
In its announcement, the FDA urges drug manufacturers to initiate the reformulation process as swiftly as possible. Recognizing the high priority for public health, the FDA has enacted these guidelines without prior comment, emphasizing the urgency of addressing benzene-related safety concerns.
Historically, USP carbomer monographs allowed for benzene levels of 100 parts per million (ppm) or more. In response to safety concerns and to eliminate confusion, the FDA has requested that USP remove these benzene-containing carbomer monographs from their compendium. USP has expressed its intention to remove five benzene-containing carbomer monographs by August 1, 2025, in line with the FDA’s request.
Benzene, considered a known carcinogen, has been associated with an increasing number of recalls and warning letters tied to drug products. This prompted the FDA to take action, warning that any drug containing more than 2 ppm benzene is adulterated and should be subject to recall.
The FDA’s guidance aligns with the International Council for Harmonisation (ICH) Q3C guidance on residual solvents, emphasizing that if benzene use is unavoidable and offers significant therapeutic benefits, its levels should be limited to 2 ppm. These guidelines also adhere to the FDA’s scale-up and post-approval changes (SUPAC) guidelines.
When transitioning to non-benzene-containing carbomers, applicants and manufacturers are advised to assess the impact of these changes on the drug product’s identity, strength, quality, purity, and potency.
The final guidance provides recommended reporting categories and necessary documentation for reformulation with various dosage forms. For instance, for semisolid dosage forms, manufacturers should follow the recommendations in the SUPAC guidance for nonsterile semisolid dosage forms issued in May 1997. Immediate-release solid oral dosage forms should adhere to the recommendations in the SUPAC guidance for immediate release solid oral dosage forms issued in November 1995, while modified-release solid oral dosage forms should follow the recommendations in the SUPAC guidance for modified release solid oral dosage forms issued in September 1997.
Regarding marketed drugs, most reformulation changes should be submitted as either a changes being effected (CBE-30) supplement or prior approval supplement (PAS), as specified in the guidance.
Carbomers, defined in the guidelines as a group of polymers consisting of acrylic acid, serve as inactive ingredients in drug product fillers, emulsifiers, gelling agents, and binding agents. Some carbomers are currently manufactured with benzene as a polymerization solvent.
People can be harmed by drug products containing benzene due to the potential risk of exposure to this carcinogenic substance. The health consequences may include the development of various cancers and other serious health conditions. Victims who have been adversely affected by benzene-containing drug products may have legal recourse to seek compensation for their injuries.
Filing a Benzene Product Liability Lawsuit
To file a lawsuit seeking damages in cases involving benzene-contaminated drug products, individuals should consult with an experienced attorney who specializes in product liability cases. These lawsuits typically fall under the category of product liability, specifically focusing on defective or unsafe products that have caused harm to consumers.
The lawsuit process begins with the victim and their attorney gathering evidence to establish a strong case. This evidence may include medical records, documentation of the use of the specific drug product, and expert testimony regarding the health risks associated with benzene exposure.
Having an attorney is crucial at every step of the process, as they can help victims navigate the complexities of product liability law and ensure that their rights are protected. Attorneys can assist in filing the lawsuit, negotiating with the responsible parties, and representing victims in court if necessary.
In a product liability lawsuit concerning benzene-contaminated drug products, victims may be eligible to recover various damages. These damages can include medical expenses, lost income, pain and suffering, and compensation for any long-term health effects or disabilities resulting from benzene exposure.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Your health and well-being matter, and Parker Waichman LLP is committed to advocating for victims’ rights and holding those responsible for benzene contamination accountable for their actions. Don’t hesitate to seek the legal guidance and support you need to pursue justice and compensation for your injuries.
If you or a loved one has been harmed by a drug product containing benzene, it is essential to take action and seek legal assistance promptly. The national product injury law firm Parker Waichman LLP is dedicated to helping victims in such cases. They offer a free consultation to individuals who call 1-800-YOUR-LAWYER (1-800-968-7529), providing an opportunity to discuss their situation and explore potential legal remedies.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.
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