What do you do when you find out the drug designed to improve your compromised immune system may be responsible for giving you Hepatitis C. This was the question facing Baxter Laboratories who manufactured and sold a product known as Gammagard S/D. They decided to discontinue manufacturing the product.
Gammagard S/D (immune globulin intravenous (human)) for his intravenous solution manufactured using plasma from human beings. It is administered as a sterile solution that is designed to help the body maintain a high level of immunity and improve the body’s ability to fight disease. Baxter announced at the end of February 1994 that it was going to remove product from the global market because of the evidence making it the transmission of the hepatitis virus. Included in the viruses linked to Gammagard S/D is Hepatitis C. The following year the FDA said Gammagard might be linked to as many as 1000 cases of Hepatitis C. Symptoms of Hepatitis C frequently are not displayed until many years after exposure.
There are two types of Hepatitis C; they are acute Hepatitis C and chronic Hepatitis C. The acute type of Hepatitis C usually occurs within six months after exposure to the virus. Unfortunately, although Hepatitis C is a short-term infection most patients who are stricken with it go on to develop chronic infection. Chronic Hepatitis C is serious diseases that can be very damaging over the long-term can even result in death.
Most people with chronic Hepatitis C do not display any symptoms and doctors find the disease when they conduct routine blood tests to check on patient’s liver functions.
On January 15, 2010, The United States Food and Drug Administration issued a stern warning to Baxter that noted serious and significant deviations from good manufacturing practices (cGMP) at the Baxter own manufacturing facility in Belgium. The products Baxter was manufacturing there were Gammagard liquid and intermediates of Gammagard S/D.
Baxter Laboratories considers Gammagard a product line and makes a differentiation between Gammagard S/D and Gammagard liquid. Baxter has never stopped manufacturing nor testing of Gammagard liquid.
Moreover, the FDA has received 1348 reports linking Gammagard liquid to serious adverse events. According to the FDA, the top three events are:
Other serious side effects known to be caused by this medication are:
- Becoming disoriented or confused
- Trouble breathing
- Serious urine infection
- Dark urine
- Headache, fever and vomiting
- Weight gain
- Kidney damage
Nevertheless, in June 2012 the FDA granted Baxter’s request to market Gammagard liquid for patients with Multi-Focal Muscle Neuropathy.
In July 2012, news media reported that Baxter had been conducting clinical trials for the use of Gammagard in the treatment of Alzheimer’s disease. Following a three-year study wherein Alzheimer’s patients were given Gammagard, it appears that Gammagard is helpful in treating this devastating disease.
In August 2012, Baxter announced once again that it would discontinue manufacturing Gammagard S/D at the end of 2012.
Recalls, approvals for new diseases, ongoing clinical trials, poor manufacturing practices, and manufacturer’s decisions to cease making a product add up to just one thing: Gammagard remains a threat and patients recently diagnosed with Hepatitis C and received Gammagard in the past may be in a position to file a Gammagard lawsuit.