In the United States, the Food and Drug Administration (FDA) is responsible for ensuring that medicine distributed on the market is effectively tested before being consumed by anyone. Even after a form of medicine is distributed on the market, the FDA still has an obligation to American consumers to continue to monitor the medicine for any potential issues in the future. If the safety of a medication is called into question, or there is any concern as to whether a form of medicine is still safe to take, it is the responsibility of the FDA and the drug manufacturer to issue a recall.
Lupin Pharmaceuticals voluntarily recalled their Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets in October for an N-nitrosoirbesartan Impurity. These types of tablets are used to treat hypertension (high blood pressure). The company decided to voluntarily recall all batches of the Irbesartan tablets in the 75 milligram, 150 milligram, and 300 milligram strengths, as well as the Irbesartan and Hydrochlorothiazide tablets in the 150 mg/12.5-mg and 300-mg/12.5 mg strengths.
To date, the company has received four reports of illness from the Irbesartan tablets, and none for the Irbesartan and Hydrochlorothiazide tablets, between October 8, 2018 and September 30, 2021. The company declared that the four illnesses were not related to the N-nitrosoirbesartan impurity.
Why are the tablets being recalled?
Lupin Pharmaceuticals decided to recall the two types of medication after batches of the medicine were above the specification limit for N-nitrosoirbesartan, a potentially carcinogenic substance that can cause cancer, making it a potentially dangerous drug. Although the batches were not finished, there were still high levels of N-nitrosoirbesartan present in the batches. The company made the decision to stop marketing the tablets in January of this year.
Why this particular recall matters
According to the Centers for Disease Control & Prevention, about 116 million adults in the U.S. suffer from hypertension, and around 500,000 deaths have hypertension listed as their primary or secondary cause.
A number of hypertension drugs have been recalled over the past couple of years, including popular brands Valsartan and Losartan. Every single one of these drugs is manufactured overseas, where compounding centers may not follow the same rigorous standards that U.S. facilities are required to follow, under the Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations were set by the FDA, and the agency generally uses surprise inspections as a way to ensure they are being followed. However, the FDA faces significantly more challenges when manufacturing facilities are in foreign countries.
How is Lupin Pharmaceuticals advising patients to proceed after the recall?
Lupin Pharmaceuticals is in the process of notifying all wholesalers, mail-order pharmacies, supermarkets, and drug chains about the recall through phone. The company is also making arrangements for the return of all recalled products. For patients who are currently taking any of the tablets listed, the company has advised patients to continue to take their medication and contact their healthcare provider for advice about a recommended alternative treatment.
Wholesalers, drug chains, supermarkets, and mail-order pharmacies with the listed tablets are supposed to cease all distribution of the recalled products immediately, and return the products to Inmar Rx Solutions, Inc.
What if I experience adverse reactions to these drugs?
If a patient begins to experience any adverse reactions or quality issues with any of the listed tablets, the patient or an organization can report to the FDA’s MedWatch Adverse Event Reporting program. Individuals can contact the MedWatch Adverse Event Reporting program either online, through the mail or by fax. Patients can access the online form through the FDA’s website. To submit the form through the mail or through fax, patients or organizations can download the form from the FDA’s website or call the listed phone number to access the reporting form. After the form is filled out, the form must be returned to the address on the form, or submitted by fax to the listed fax number on the FDA website.
Should I stop taking my medications if they have been recalled?
Generally speaking, you should never stop taking any medication without speaking t your doctor first. Hypertension is a serious medical condition that can cause life-threatening heart disease, stroke, heart attacks or aneurysms if left untreated. Contact your doctor immediately to find out what you should do.
Can the company be held liable in the future?
If it is proven that a consumer was hurt or injured from a manufacturing defect from a company’s product, that company can be held liable for the consumer’s injuries. Companies can also be held liable if the drug has been marketed incorrectly or fails to warn consumers about the potential risks. If there are defects discovered in the drug itself, and the risks associated with a drug outweigh the potential benefits, companies can also be held liable for any damages that the consumers sustain. In addition to the manufacturing company, other parties can be held liable for any damages that the consumers sustain.