Blood pressure medication recalled over high levels of cancer-causing chemical – NBC 5 Chicago

Report on Pharmaceutical Recall and Implications for Sustainable Development Goals

Executive Summary

A voluntary recall of a widely distributed blood pressure medication, Prazosin Hydrochloride, has been initiated by Teva Pharmaceuticals USA Inc. This action, prompted by the detection of a potentially carcinogenic impurity, directly impacts the advancement of key United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being). The incident highlights critical failures in ensuring the safety and quality of essential medicines, a cornerstone of Target 3.8, and underscores the health risks associated with hazardous chemicals, as addressed in Target 3.9.

Recall Details

The recall, detailed in a U.S. Food and Drug Administration (FDA) enforcement report, encompasses specific lots of Prazosin Hydrochloride capsules. The key details are as follows:

• Company: Teva Pharmaceuticals USA Inc.
• Product: Prazosin Hydrochloride Capsules
• Quantity Recalled: 580,844 bottles
• Dosages Affected: 1 mg, 2 mg, and 5 mg
• Distribution: Nationwide

Impact on SDG 3: Good Health and Well-being

This recall represents a significant challenge to achieving SDG 3, which aims to ensure healthy lives and promote well-being for all at all ages.

1. Violation of Medication Safety (Target 3.8): Target 3.8 calls for access to “safe, effective, quality and affordable essential medicines.” The presence of N-nitroso Prazosin impurity C at levels “above acceptable intake limits” constitutes a failure to provide safe medication, undermining public trust and patient health.
2. Exposure to Hazardous Chemicals (Target 3.9): The impurity is identified as a cancer-linked chemical compound. This event is a direct example of the public health threat addressed by Target 3.9, which seeks to substantially reduce illnesses from hazardous chemicals and contamination.

Regulatory Classification and Risk Assessment

The institutional response provides context to the level of risk, which is crucial for evaluating progress toward SDG 16 (Peace, Justice and Strong Institutions) and its emphasis on effective and accountable institutions like the FDA.

• Recall Initiation Date: October 7
• FDA Classification: Class II (issued October 24), indicating that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
• Company Hazard Assessment: Teva USA’s Health Hazard Assessment rated the overall harm to the patient population as “medium.”

Link to SDG 12: Responsible Consumption and Production

The incident also relates to SDG 12, which encourages sustainable production patterns. The contamination points to a lapse in quality control within the pharmaceutical manufacturing process.

• Chemical Management (Target 12.4): This target focuses on the environmentally sound management of chemicals throughout their life cycle to minimize adverse impacts on human health. The failure to control chemical impurities in a final medicinal product is a direct contravention of this principle.
• Corporate Responsibility (Target 12.6): This event underscores the critical need for companies to adopt sustainable practices, including stringent quality control and transparent reporting, to safeguard public health and align with global sustainability objectives. The recent recall of another major drug, Lipitor, for different quality issues suggests a broader systemic challenge in the pharmaceutical supply chain that impedes responsible production.

1. SDGs Addressed in the Article

SDG 3: Good Health and Well-being

• The article directly addresses public health by discussing the recall of a blood pressure medication used to treat hypertension, a non-communicable disease. The central issue is the contamination of this medicine with a potentially cancer-causing chemical, which poses a direct threat to the health and well-being of patients.

SDG 12: Responsible Consumption and Production

• The recall highlights a failure in the production process, where a pharmaceutical product did not meet safety standards. This relates to ensuring sustainable production patterns, which includes the safe management of chemicals and corporate responsibility for product safety throughout its lifecycle. The voluntary recall by the company is an action related to responsible corporate practice.

2. Specific SDG Targets Identified

Targets under SDG 3: Good Health and Well-being

• Target 3.8: Achieve universal health coverage, including… access to safe, effective, quality and affordable essential medicines… for all. The article’s focus on the recall of contaminated Prazosin Hydrochloride capsules directly concerns the “safe” and “quality” aspects of essential medicines. The presence of a carcinogenic impurity means the medicine provided was unsafe and of poor quality, undermining this target.
• Target 3.9: By 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination. The recall was initiated because the medication contained “above acceptable intake limits” for N-nitroso Prazosin impurity C, a “cancer-linked chemical compound.” This is a clear instance of potential illness resulting from contamination by a hazardous chemical, which this target aims to reduce.

Targets under SDG 12: Responsible Consumption and Production

• Target 12.4: By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle… and significantly reduce their release… to minimize their adverse impacts on human health. The contamination of the medication with a chemical impurity (N-nitroso Prazosin) represents a failure in the management of chemicals during the production life cycle, leading to a direct adverse impact on human health.

3. Indicators for Measuring Progress

Implied Indicators from the Article

• Number of pharmaceutical product recalls due to chemical contamination: The article provides a specific instance of a recall (Prazosin Hydrochloride) and mentions another (Lipitor), suggesting that tracking the frequency of such events is a key measure of product safety.
• Volume of unsafe products removed from the market: The article explicitly states that “580,844 bottles” were recalled. This quantifiable data serves as a direct indicator of the scale of the failure in providing safe medicine.
• Classification of health risk from unsafe products: The article mentions the recall was classified as “Class II,” which means the product “may cause temporary or medically reversible adverse health consequences.” This classification system provides a qualitative indicator to measure the severity of risks to public health.
• Level of hazardous impurities in consumer products: The article notes the recall was due to the capsules having “above acceptable intake limits” for a cancer-linked chemical. Measuring and reporting the incidence of products exceeding these safety limits is a crucial indicator of progress towards Target 3.9 and 12.4.

4. Summary Table of SDGs, Targets, and Indicators

Source: nbcchicago.com