Recall of Bleeding Disorder Drug Leaves Patients with Unanswered Questions

According to a story from hemophilia.org, the drug company Ferring Pharmaceuticals issued a recall of the nasal spray drug desmopressin (marketed as Stimate) on July 21st, 2020. This product is commonly used to treat bleeding disorders, including mild cases of hemophilia A and von Willebrand disease (vWD). The recall was initiated due to issues of “superpotency,” in which vials of the medicine had a greater concentration of desmopressin than they were supposed to. The drug is licensed by CSL Behring in the US and production of the medication has halted while Ferring conducts an investigation. Of particular concern was the delayed FDA MedWatch Safety Alert, which only appeared on the agency website on the fifth of August.

About Hemophilia

Hemophilia is a genetic disorder which affects the ability of the blood to form clots, a process that is vital for stopping bleeding after a wound is sustained. Symptoms include bleeding for a long time after an injury, risk of bleeding in the brain and joints, and easy bruising. Bleeding in the joints can cause permanent damage and brain bleeding can lead to headaches, decreased consciousness, and seizures. To learn more about hemophilia, click here.

About Von Willebrand Disease

Von Willebrand disease (vWD) is a blood clotting disorder, and is the most common type that affects people. Interestingly, blood type has a significant influence on the severity and presentation of symptoms, which include frequent nosebleeds, easy bruising, and bleeding from the gums. In the most severe type 3, internal bleeding, such as in the joints, can occur. To learn more about von Willebrand disease, click here.

The National Hemophilia Foundation (NHF) and the Hemophilia Foundation of America (HFA) sent a letter to the companies with various questions about the nature of the recall. Unfortunately, not all of their questions received a direct response.

The questions as written in the letter are listed below:

  • How did the product deviation occur, and how was it discovered?
  • What are the risks to patients who use the affected product?
  • Has either company received any adverse effect notifications in the US or overseas?
  • How do the companies account for the fact that the product was distributed for over two years before the problem was detected?
  • How do the companies explain their delay in notifying U.S. customers of the recall (up to 10 days after recalls were announced in other countries)? and
  • How do the companies plan to accomplish the recall and to make sure that information about the recall reaches those who need to know, both patients and providers?

Issues raised by the patients groups included the delay in announcing the recall in the US, lack of specifics on how the recall will be conducted, and the discovery that affected doses had been in the product supply for at least two years. In addition, the companies were unable to answer questions about supply, the resumption of production, or the duration of the internal investigation.

The incompleteness of response is of great concern to patients that depend on this medication to control the symptoms of their bleeding disorder.

The NHF and HFA’s official letter can be found here.

The reply letter from Ferring Pharmaceuticals and CSL Behring can be read here.

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