Recent research and evidence regarding the risks of using Fluconazole while pregnant have turned up some disturbing facts and trends. Fluconazole lawsuits may be on the horizon sooner rather than later as the women and their children who have suffered because of this medication and their legal representation begin to plan their cases and seek justice and compensation from the drug maker.
Fluconazole is an antifungal medication, which has been in use since 1990 and was first developed and brought to market by Pfizer. It also goes by the brand name Diflucan and is used to treat a number of infections including vaginal yeast infections. It is this common use for the medication that may lead to a number of lawsuits. It is only recently that evidence has come to light showing that the use of fluconazole by women while pregnant can cause specific birth defects and miscarriages.
Fluconazole Uses and How it Works
Diflucan was developed and tested by Pfizer in the 1980s and the U.S. Food and Drug Administration approved it in 1990. Pfizer’s patent has since run out and other companies now make their own versions of the generic drug fluconazole. It is a triazole drug, and it battles fungal infections by interfering with a certain enzyme. This results in slowing the growth and division of fungal cells and stops infections.
The FDA approved fluconazole to treat certain types of fungal infections as well as to prevent these infections in certain vulnerable patients. One of the most common uses for fluconazole is to treat vaginal yeast infections. This is why so many pregnant women ended up taking the drug and researchers were able to uncover the link to birth defects and pregnancy complications and why fluconazole lawsuits are expected to rise over the next couple of years.
Other types of fungal infections that fluconazole is approved to treat are yeast infections in the mouth, esophagus, abdomen, blood, and lungs. It may also be used to treat the fungal form of meningitis, an infection of the meninges that covers the brain and spine. Vulnerable patients such as those with compromised immune systems or those who are undergoing chemotherapy or radiation treatment may be given fluconazole to prevent the onset of fungal and yeast infections.
Side Effects of Fluconazole
Side effects that patients aren’t expecting and that are devastating and even life-threatening tend to be what lead to lawsuits over prescriptions like fluconazole. Most of the side effects of this drug are well known and were reported when the medication came on the market. These are uncomfortable and some can be serious, but none are expected to lead to lawsuits.
Among the most common side effects of fluconazole are skin rashes, dizziness, vertigo, headaches, diarrhea, vomiting, nausea, flatulence, abdominal pain, hair loss, seizures, tight muscles and muscle spasms, excessive thirst, indigestion, insomnia, sexual dysfunction, nervousness, vision problems, flushing of the skin, fatigue, and for women, bleeding between periods.
There are some rarer, but very serious possible side effects, which although reported, may lead to lawsuits in the future if patients feel they weren’t adequately warned of the severity of the risks. One of these is the potential damage to the liver. Fluconazole rarely causes liver toxicity, hepatitis, cell death in the liver, jaundice, liver damage, and even liver failure culminating in death. This is especially a risk for people with HIV, cancer, or a history of liver damage.
Birth Defects Likely to Lead to Fluconazole Lawsuits
The main reason that Pfizer may be facing lawsuits over fluconazole is because the drug has recently been found to be implicated in birth defects. Although it has been on the market since 1990, it was only in 2011 that the FDA issued a safety warning about this risk. Many women and their children were put at risk during this more than 20 year period. Because Pfizer failed to warn women about this risk, they may be paying out lawsuit settlements in the future.
The safety announcement from the FDA came after a study found that women using high doses of fluconazole during pregnancy—between 400 and 800 milligrams—were at a significant risk of giving birth to babies with very specific defects. These include cleft lip and palate, long bones, thin ribs, deformed joints, face and skull deformities, bowed thigh bones, muscle weakness, and congenital heart defects.
Because of this risk coming to light the FDA not only issued a warning but also changed the pregnancy category for high doses of fluconazole. The category changed from C to D and the new rating makes it clear that it is a drug and dose that is known to cause harm to human fetuses in the womb.
Miscarriages Could Lead to Lawsuits
Birth defects are not the end of the story or the end of potential trouble for Pfizer. In 2016 the FDA issued another warning about fluconazole. This came after a study found that even low doses of the drug could cause complications for pregnant women. The study looked at women receiving a 150 milligram dose to treat vaginal yeast infections during pregnancy and found that they were at a significant risk for having a miscarriage.
The warning also stated that the FDA would continue to investigate and analyze the study. The agency has not yet decided whether it will change the pregnancy category for low dose fluconazole to D, although it seems likely to happen in the future. The current labeling for fluconazole states that there is no known risk for pregnant women taking low doses of the drug, but that may change soon.
The Potential for Fluconazole Lawsuits
With all the new information about the risks of using fluconazole during pregnancy, the possibility of lawsuits being started against Pfizer is highly likely. Women used this medication for two decades before being told it could harm their unborn children. Many are now living with a child that will have to cope with a defect for life and this could have been avoided if Pfizer had tested its drug more thoroughly and better warned the public. Because this drug is a popular choice for yeast infections, and women commonly get these infections, possibly millions of women and their children were put at risk.
Plaintiffs in any future cases against Pfizer could make a number of claims against the company. They are likely to accuse Pfizer of negligence, of failing to adequately warn patients, of producing a defective product, and of misrepresenting a medication as safe or low-risk for pregnancy. If you were impacted by fluconazole, talk to a lawyer to be one of the first women to make your case and seek compensation.