Bayer makes a medication called Kogenate that is used in people who suffer with the bleeding disorders known as hemophilia. Doctors prescribe the medication to prevent excessive bleeding, but recently it suffered a recall. Bayer announced the recall in July. Bayer issued follow up in August to extend it to include more lots. At issue was the potency of the medication.
Kogenate and Hemophilia A
Bayer received approval for Kogenate through the U.S. Food and Drug Administration (FDA) for use in patients with hemophilia A in 2014. Hemophilia A is also known as classic hemophilia and factor VIII deficiency. This is a genetic disorder that is characterized by the absence of a clotting protein in the blood called factor VIII.
Without factor VIII a person’s blood cannot clot, which is very dangerous. People with hemophilia A may suffer from nosebleeds and other types of bleeding. These can include bleeding in the urinary tract and joint bleeding. Over time this can cause complications such as joint problems. These may ultimately lead to joint replacements. Other complications include brain hemorrhages, which can be fatal, and the formation of blood clots as a result of treatments, which can also be fatal.
Hemophilia is genetic and incurable, but it is treatable. Bayer designed Kogenate to replace factor VIII so that a person with this illness can actually clot. The FDA approved it for prophylactic use. For instance, doctors can use Kogenate before surgeries that could cause dangerous bleeding or to prevent joint damage caused by excessive bleeding.
Problems with Potency
For some people this kind of drug is a life saver. Having surgery, for example, is a huge risk for someone whose blood will not clot. That person is at risk of dying because of surgical incisions and the blood loss that may result from a procedure. Having a medication that can provide life-saving clotting factors makes the difference between being able to have a surgical procedure done and suffering because it is too risky.
When Bayer made the announcement in late July that it would be recalling two lots of Kogenate, the reason was potency. Routine stability testing of the product found that nearly 2,000 doses of the medication were at risk of losing potency. They lost potency to an extent that Bayer considered unacceptable and even dangerous for those patients relying on the drug. The lots recalled in July because of this issue included two lots of Kogenate FS 2000 IU Vial Adapters with lot numbers 270R978 and 270TN1C.
In early August Bayer then announced that it tested more samples of the medication. These were samples with the active ingredient that had been manufactured before November of 2015. These too had lost potency and Bayer also recalled them. The extended recall included Kogenate FS 2000 IU Vial Adapter with the lot number 270PWG8 and Kogenate FS 3000 IU Bio-Set with the lot number 270NPV2.
The lots that Bayer already recalled have suffered an unacceptable loss of potency. There are also several lots of Kogenate that Bayer believes may suffer that same loss in the future. Bayer has not yet recalled eight lots that fall into this category. Both Bayer and the FDA are monitoring them to decide if they need to issue such a recall in the future. In the meantime, physicians, pharmacists, and others who have drugs from these lots are keeping them quarantined until further notice.
Kogenate is an important medication for many patients. While hemophilia A is not a common medical condition, there are thousands of people who live with it every day. These people rely on the potency of drugs like Kogenate to survive and thrive. Bayer made a mistake, but corrected it with a quick, voluntary recall.