Fluconazole is the generic name for a drug that was developed as the brand name medication Diflucan by Pfizer. It first came on the market in 1990 and since the patent ran out it is available through several manufacturers as a generic drug as well as through Pfizer as Diflucan. Fluconazole is an antifungal and is used to treat a variety of fungal infections for patients with varied conditions.
Lawsuits may be pending over fluconazole and Diflucan as some of the more serious risks of using the medication come to light with the latest research. Only recently the U.S. Food and Drug Administration (FDA) announced that it was reviewing study data that may show the drug causes birth defects, miscarriages, and stillbirths in women who used it while pregnant.
What is Fluconazole?
Fluconazole, or Diflucan, is a medication used to treat fungal infections, like vaginal yeast infections, among others. It can also be used to prevent fungal infections in certain patients who are vulnerable to them for various health reasons. It is available as a tablet and liquid suspension, taken orally. Pfizer first developed fluconazole in the 1980s and was approved by the FDA and brought to market in 1990
How it Works and Uses
Fluconazole belongs to a class of antifungals called triazoles. It works to treat fungal infections by slowing the growth of fungal cells. More specifically it inhibits a particular enzyme related to the membrane of fungal cells. Humans have this enzyme also, but the human version is not as sensitive to fluconazole as the fungal one is. Some fungi are killed by the drug, but most are simply slowed down in the process of growing and dividing, which has the effect of stopping the infection.
When the FDA approved fluconazole, it did so for specific types of fungal infections and certain patients, not just for any type of infection. It is approved to treat yeast infections of the vaginal, esophagus, throat, mouth, abdomen, blood, and lungs. It can also treat fungal meningitis, an infection that attacks the membrane that covers the spine and brain.
In preventing fungal infections, fluconazole can be used for patients undergoing chemotherapy or radiation for cancer treatment. They are more vulnerable to infections. It can also be used in patients with AIDS who have had a particular type of fungal infection called cryptococcal meningitis to prevent its recurrence. Although not indicated for these uses, fluconazole may also be prescribed to treat fungal infections of the prostate, eye, and skin.
There are many potential side effects of using fluconazole to treat or prevent a fungal infection. Those that are most commonly reported include headaches, skin rashes, nausea, vomiting, diarrhea, gas, and abdominal pain. Also possible are alopecia, or hair loss, dizziness, vertigo, seizures, muscle spasms, tight muscles, indigestion, excessive thirst, nervousness, insomnia, sexual dysfunction, bleeding between periods, vision problems, fatigue, and flushing.
It is also possible that fluconazole can cause liver damage and toxicity. Hepatitis, jaundice, death of liver cells, and even liver failure are all possible. Liver failure can be severe enough to lead to death. The risks of liver side effects of fluconazole are especially increased for anyone with existing or previous liver problems, or underlying conditions like HIV or cancer.
Some patients may also experience a severe allergic reaction to fluconazole called anaphylaxis. This is fatal if not treated immediately. It is also possible to overdose on this drug. An overdose causes hallucinations, either visions or voices and extreme paranoia, specifically that someone is out to hurt the person experiencing the overdose. This should also be treated as a medical emergency.
Birth Defects at Higher Doses
In 2011 the FDA announced that Diflucan and other fluconazole products could cause serious and specific birth defects. This risk occurred when women took higher doses of the drug during pregnancy. Doses considered high enough to cause birth defects were between 400 and 800 milligrams. A more typical dose used to treat yeast infections in women is 150 milligrams.
The announcement included a change in pregnancy category from C to D. A pregnancy category of D means that there is research evidence that a medication puts a human fetus at risk. This category also means that a drug can still be used in a pregnant woman if she is facing a serious or a life-threatening condition.
The birth defects seen in the children of women taking higher doses of fluconazole were very specific and included an abnormal face and skullcap, a short and broad head, a cleft lip or cleft palate, thin ribs, long bones, bowing in the thigh bones, joint deformities, muscle weakness, and heart defects. These defects were seen in women who not only had high doses of fluconazole, but who took those high doses over a long period of time.
Birth Defects and Pregnancy Complications at Lower Doses
At the time of the 2011 FDA announcement the agency stated that there was no risk for birth defects in the children of women taking the low dose, 150 milligrams, of fluconazole for vaginal yeast infections while pregnant. Fluconazole at that does remained a category C pregnancy drug, meaning that while animal studies showed potential risk to a fetus, the same risk was not seen in human trials.
In early 2016, the FDA sent out another announcement regarding pregnancy risks for fluconazole. This followed the publication of a Danish study that did seem to find that lower doses of the medication could cause certain complications. The study included more than 3,000 women who were exposed to lower doses of fluconazole. The researchers concluded that this exposure significantly increased the risk of miscarriages.
The FDA’s most recent announcement did not necessarily come to the same conclusion, but the agency stated that it would be reviewing the research. It will make a later decision about whether or not to move low doses of fluconazole to category D for pregnancy. In the meantime, the agency recommends that doctors and women be very cautious about the prescription and use of fluconazole during pregnancy. It also encourages women and their doctors to report any adverse events to the FDA reporting system to help the agency make more informed decisions about fluconazole.
Because of the very serious risk of birth defects and even miscarriages at lower doses of fluconazole it will probably be just a matter of time before lawsuits are brought against Pfizer and other makers of the medication. This is especially true because fluconazole has been on the market for nearly 30 years. Many women who have given birth to children with defects or who experienced a miscarriage may feel that Pfizer did not do enough to warn them about these risks.
Drug makers have a responsibility to thoroughly test their products before putting them on the market and they are supposed to provide adequate warning of the risks of side effects. If you took fluconazole and had a child with a birth defect or a miscarriage, you may want to consider filing a lawsuit because Pfizer did not live up to its responsibilities. Lawyers are currently considering cases over fluconazole and there may be an opportunity to seek compensation for your child.