Photo of a medicine bottle on the floor with capsules outside of it

In yet another case of potentially dangerous drugs, another voluntary recall has been made by a pharmaceutical company. 

Recalls are the ultimate solution to save patients from the risk of potentially harmful drugs or medical devices. A good example is what the Paragard lawsuits aim for. The recall of the Paragard IUD which has affected many people’s lives in negative ways over its adverse effects. Even though the legal proceedings are new, there is already an increase in plaintiffs filing their claims to make the manufacturer, Teva Pharmaceuticals, accountable. 

And this news of a drug recall might help encourage people to step forward, know their rights, and put abusive pharmaceutical companies in their proper place.

In early December, the USFDA announced a voluntary nationwide recall of one lot of anagrelide capsules, USP after a failure in the dissolution test was detected during routine quality testing. 

What are Anagrelide Capsules Used For?

Pills packaging with empty shelves

Anagrelide is meant to treat a blood cell disorder called thrombocythemia or thrombocytosis, which occurs when the body elevates platelet counts. If the body produces too many platelet cells, it can lead to certain conditions, including heart attack, stroke, or a clot in the blood vessels. 

What does a Failed Dissolution Test Mean?

A failed dissolution test can result in a slower rate and extent of drug release, leading to lesser amounts of anagrelide available in the body. This could have life-threatening effects for seriously ill patients with elevated platelet counts, as this increases their risk of blood coagulation and other clotting or bleeding events such as stroke or a heart attack.

What You Can Do

A doctor and a patient greeting each other with a handshake

Patients currently taking anagrelide are asked by the U.S. Food and Drug Administration to talk to their physician or healthcare provider first before stopping taking the medication immediately. This is because the risk of harm in doing so may even be greater than the dissolution concern.

Torrent Pharmaceuticals said that the lot of faulty Anagrelide Capsules, USP was deployed in the U.S. nationwide to the company’s wholesale distributor and retail customers. The pharma company is also in the process of notifying its customers and distributors, whether by phone or writing, to immediately discontinue the distribution of the specific lots impacted by the recall. 

Torrent Pharmaceuticals Limited is also arranging for the return of the recalled lots to Qualanex. 

To date, no adverse effects from the affected lots related to this recall had been reported, according to the FDA.  

Leave a Reply

Your email address will not be published.

top