Bayer Issues a Recall of Mislabeled Biologic Medications

recall, medication recall

Pharmaceutical giant Bayer is voluntarily recalling nearly one thousand vials of a biological drug used to treat patients with hemophilia A.  The U.S. Food and Drug Administration (FDA) published the recall in July, 2019 explaining the danger to patients who rely on the drug.  Medication recalls relating to mislabeled drugs are certainly a concern for patients.

The recall applies specifically to two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials.  The recall is because the medication is mislabeled.  Inside the vials is actually a different medication: FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

Bayer Recall Information for Consumers

The lot numbers of the recalled drugs are:

  • 27118RK
  • 27119CG

Bayer distributed the mislabeled vials between February 5, 2019 and July 15, 2019.  The recall affects only consumers in the United States.  The manufacturer says the majority of the mislabeled vials “were recovered,” but they did release about 990 vials containing the wrong medication.

The batch of Jivi medication expired in August, 2018.  Any patient exposed to the mislabeled drugs has not only been taking the wrong medication, but has also been taking expired medication.

Somewhat sheepishly, Bayer offered the information that the expired Jivi batch met stability specifications for biologic medication as of April, 2019.  They went on to indicate that the recall is in the interest of patient safety.  The stated mission of the recall is to remove any and all potentially mislabeled products from pharmacy shelves.

Vials of Kogenate FS that are not involved in this recall are safe to use for hemophilia A patients without interruption.

What to Do If you Have the Mislabeled Medication

Both medications are intended for use to treat hemophilia A by replacing a clotting factor in people with the condition.  Hemophilia A can be deadly if improperly treated.  Any consumers who are in possession of the mislabeled vials should stop using the product immediately and contact their physician.  The FDA is also urging consumers to contact the dispensing pharmacy to return the product.

What are Biologic Medications?

Kogenate FS is a biologic medication.  It is unclear whether the mix-up between the two different brands is more or less dangerous because the recalled products are biologics instead of conventional medications.  Either way, improper treatment of hemophilia A is dangerous.

Biologic medications differ from conventional prescription drugs because they come from many different types of living sources and are often manufactured using whole, biological cells.  Some sources of biologic medications include:

  • Mammals
  • Birds
  • Insects
  • Plants
  • Bacteria

Biologic medications are at the cutting edge of medical advancement.  Gene-based and cellular biologics are contributing to treatment options that have never been possible before.  Furthermore, in some cases, biologics are the first available treatment option for certain conditions.

Biologic medications are more complicated than conventional drugs.  They are usually more costly and time-intensive to produce.  Once in their final form, biologics are less shelf-stable than conventional drugs.  Unlike traditional pills and capsules, biologics are generally very sensitive to light and temperature extremes.

About Kogenate FS Antihemophilic Factor 

The drug that should have been in the vials that Bayer is recalling is a coagulation (clotting) factor made using DNA technology.  Pharmaceutical scientists introduce the human factor VIII gene into Baby Hamster Kidney (BHK) cells.  Subsequently, the hamster cells make the clotting factor hemophilia that patients lack.

When the medication is purified, it contains Human Plasma Protein Solution (HPPS) and recombinant human factor VIII.  Amazingly, it does not retain any proteins derived from animal sources once it is in the vial and ready for consumer use.

What is Hemophilia?

Hemophilia is a somewhat rare bleeding disorder that prevents the patient’s blood from clotting normally.  Blood that clots properly allows wounds to heal quickly.  Hemophiliacs can experience extensive bleeding from minor cuts and injuries.  They can also experience spontaneous internal bleeding.  Without careful and diligent treatment, the condition can certainly be fatal.

By and large, men make up the primary population of hemophiliacs.  There are extremely rare circumstances in which a woman could have the disorder, but most cases involve men.  There are two types of hemophilia:

Hemophilia A

The more common type, which is the result of a deficiency in factor VIII.  The factor is a protein that helps blood to clot.  The biologic medication in this recall should have replicated the missing protein in hemophiliacs’ blood.

Hemophilia B

Rarer, this condition is the result of a deficiency of the protein factor IX. Without adequate levels of clotting factor IX, bleeding cannot be adequately controlled.

How Common is Hemophilia?

Both types of hemophilia are extremely rare.  According to the Cleveland Clinic, Hemophilia A affects only one in every 5,000 to 10,000 men.  Hemophilia B affects only one in every 25,000 to 30,000 men.  The majority of patients with hemophilia A have the severe form of the disorder and rely on medication to maintain their quality of life.

The genes that regulate the production of blood clotting proteins are tied to the X chromosome only.  Hemophilia occurs when the factor VIII or factor IX genes on the X chromosome mutate.

Women can be carriers of the mutated gene without having the condition themselves, much like color-blindness.  If a woman is a carrier of the gene, there is a 50/50 chance that her sons will be hemophiliacs.  If she were to have any daughters, there is a 50/50 chance they would also be carriers of the gene without having the conditions themselves.

Oddly enough, about 20 percent of hemophiliacs have no family history of the disorder. Rather, it is the result of a spontaneous gene mutation.

Getting Help with a Serious Medication Recall

Though Hemophilia is rare, Bayer did distribute 990 vials of mislabeled medication over a prolonged period of time.  Hemophilia A is a desperately serious medical condition that needs vigilant and responsible medical treatment.

If a patient relies on a certain medication and suffers adverse events because it is defective, mislabeled, or incorrect, the manufacturer can be held liable.  In the case of this recall, if a patient with Hemophilia A suffers injury while using the mislabeled product, Bayer could be held responsible.  Bayer could be liable for the injuries and suffering, as well as any resulting medical expenses.

If you or someone you love needs help understanding their legal rights relating to a medication recall, contact Drug and Device Watch.  Our legal team can certainly help you find out what your options are to protect your rights, and your health.  Call us for a free consultation at 800- 684-2136.  You can also contact us via our online form.