Why there is Quinapril shortage? The Therapeutic Goods Administration(TGA) investigates the possible contamination of several products. The doctors are urged to talk to their patients about alternative blood pressure-lowering treatments to quinapril because of the shortage.
Quinapril is marketed under several brand names in Australia. It is a medication called an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure. (also known as hypertension).
Hydrochlorothiazide, also known by several brand names, is a diuretic prescription medication frequently used with blood pressure medications to reduce fluid retention.
The TGA has been informed that deficient levels of N-nitroso-quinapril have been identified in all quinapril products sold in Australia, including quinapril combined with hydrochlorothiazide. This problem also affects quinapril product lines and quinapril with hydrochlorothiazide sold in other countries.
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What is N-nitroso-quinapril?
N-Nitroso-quinapril is an impurity that contains nitrosamine. Nitrosamines are a group of chemicals that can cause DNA damage. Long-term exposure over many years can increase a person’s risk of developing cancer.
The additional risk posed by trace levels of N-nitroso-quinapril identified in quinapril products is very likely low. However, nitrosamine impurities in medicine are generally regarded as unacceptable. The actual health risk is determined by the medication and dosage used, varying from person to person.
Quinapril recall 2023
Pfizer is recalling Accuretic (quinapril hydrochloride/hydrochlorothiazide) tablets as well as two permitted generics distributed by Greenstone (quinapril HCL and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide). This was due to nitrosamine, N-nitroso-quinapril, being above the appropriate daily intake level.
Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets.
Nitrosamines are found in various foods and beverages, including cured and grilled meats, dairy products, and vegetables. Nitrosamines are present in everyone’s environment. If people are exposed to these contaminants at levels above acceptable levels for an extended time, they may increase their risk of cancer.
These medications are intended to treat hypertension. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, most notably strokes and myocardial infarctions. The products have a proven safety profile based on 20 years of market approval and a robust clinical program.
The recalled products are intended for the treatment of hypertension. Pfizer is not aware of any findings of adverse events that have been linked to this recall as of yet. Based on available information, Pfizer believes the benefit-risk profile of the products continues. Although long-term ingestion of N-nitroso quinapril may be linked to higher cancer risk in humans, patients are taking this medication face no immediate danger.
Patients who use this product should check with their healthcare provider or pharmacy to see if they have the contaminated product. Patients who have used the recalled product should contact the manufacturer. Patients using the products should speak with their doctor about other treatment options. Medical practitioners who have questions about this recall should contact the company.
Pfizer prioritizes patient safety and product quality at every production and supply chain stage. Pfizer has notified direct consignees by letter, requesting that any recalled product be returned.
Retailers and distributors with the current stock of the lots should immediately cease use and quarantine the product.
The alternatives to quinapril are as follows:
- Enalapril (Vasotec)
- Ramipril (Altace)
TGA’s steps towards recall
The Therapeutic Goods Administration(TGA) is collaborating with quinapril medicine sponsors to further look into this problem and determine what steps should be taken. The TGA evaluated the ARTG results reported by sponsors of quinapril and quinapril with hydrochlorothiazide medicines.
Sponsors of affected medications are taking corrective measures by implementing impurity control measures to ensure that only batches of quinapril that meet globally accepted intake limits are released. The TGA and other international regulatory agencies will continue to track medicines to ensure that proper quality standards are met.
Both consumers and health professionals can report problems with medicinal products or vaccines. The reports will help the TGA with product monitoring. The TGA is unable to provide medical advice to individuals. Consumers should consult with a health professional if they are worried about a possible adverse event associated with a drug or vaccine.
Quinapril products will not be available if there is a recall or shortage. Patients should consult with their doctor about alternative treatment options. Patients must only stop taking quinapril if instructed to do so by their doctor.