Fluconazole is a useful drug that many people rely on to heal fungal infections. It was made by Pfizer, but is now available from numerous drug manufacturers since the patent expired for the brand name version, Diflucan. Although this drug has been well tolerated by many and brought comfort and relief from infections, there is a long and troubling list of fluconazole side effects that cause too many people to suffer unnecessarily.
Among those many side effects is the possibility that women using fluconazole while pregnant will give birth to a child with serious defects or that they will experience a devastating miscarriage. These awful side effects were not even reported until two decades and longer after fluconazole first came on the market. If you have suffered these side effects because you were not made aware of the risks, you may be one of the first plaintiffs in lawsuits against Pfizer over this medication.
Fluconazole came from Pfizer, the major drug maker that developed it in the 1980s and received U.S. Food and Drug Administration (FDA) approval in 1990. Pfizer marketed and sold the drug as Diflucan. Since 1990 the patent has run out and while Pfizer still offers Diflucan, other companies have also gotten in on making and selling fluconazole products for treating fungal infections.
Fluconazole belongs to the triazole class of antifungal medications. These drugs treat and cure fungal infections by acting on an enzyme on fungal cells. The result is that it slows the growth of the fungus and slows and stops the spread of the infection. The FDA approved fluconazole to treat a number of fungal infections, especially yeast infections. These include vaginal, abdominal, esophageal, lung, blood, and mouth yeast infections.
The FDA also approved fluconazole to treat fungal meningitis, a fungal infection of the covering membrane of the spine and brain called the meninges. Patients with cancer or AIDS who are vulnerable to developing fungal infections may be given fluconazole to prevent fungal infections. In fewer cases the drug may be used to treat skin, eye and prostate fungal infections.
Fluconazole Side Effects
Fluconazole is effective at treating fungal infections, but it also has the potential to cause a long list of side effects. Some of these are common and not serious, but others are devastating and some may even be life threatening. Fluconazole side effects must be carefully weighed and balanced against its benefits before patients and their doctors decide to use it.
The most common side effects are dizziness, diarrhea, vomiting, nausea, headaches, skin rashes, and elevated liver enzymes. Less common are anorexia, fatigue, constipation, alopecia (hair loss), lowered white blood cell count, seizures, muscle spasms, nervousness, sexual dysfunction, vertigo, indigestion, vision problems, and bleeding between periods for women.
A severe allergic reaction is a possible side effect for some patients. This is called anaphylaxis and it is life-threatening and requires emergency medical treatment. Signs of anaphylaxis include itchy skin and hives, swelling in the face, mouth, and throat, and difficulty breathing. It can be fatal within minutes.
Liver Side Effects
Although rare, it is possible that patients will experience serious liver side effects from taking fluconazole. This is a bigger risk for anyone with current liver problems or liver damage, a history of liver problems, and people with underlying conditions including cancer and HIV. Fluconazole may cause liver cell death, hepatitis, jaundice, and liver failure. The latter condition is ultimately fatal if not treated.
Fluconazole Side Effects Include Birth Defects
As if all the previous side effects were not troubling enough, fluconazole has recently been found to cause birth defects and miscarriages. Since the drug came on the market in 1990 millions of women and their babies were exposed to this risk without warning. The first official warning only came in 2011 from the FDA when the agency upgraded the pregnancy class of higher doses of fluconazole from C to D, a classification that communicates this drug is known to cause harm to human fetuses.
The warning and class change came on the heels of a study that uncovered the disturbing fact that doses between 400 and 800 milligrams of fluconazole cause specific birth defects when women use the drug at these doses over the long-term during pregnancy. These defects include cleft lip, cleft palate, bone defects including bowed thighbones, abnormal shaping of the face and skullcap, a head that is too broad and short, muscle weakness, and congenital heart defects.
We also now know that these pregnancy side effects do not stop at large doses of fluconazole. Another, more recent study, found that women using doses at 150 milligrams to treat vaginal yeast infections were at a significantly greater risk of having a miscarriage when compared to women using another type of antifungal medication.
The FDA issued a safety warning about low doses and miscarriages in early 2016, but made no moves yet to reclassify 150-milligram fluconazole. The agency got the information out to the public, but stated that it would spend more time going over the results of the study and doing its own analysis before making a decision about what to do next. Currently the FDA recommends that doctors take great care in prescribing fluconazole to pregnant women or women who may become pregnant and to report any adverse events to the agency for further study.
Side Effects and Lawsuits
Women who used fluconazole while pregnant have suffered some of the most terrible side effects of any medication. To have a child born with a birth defect may mean a life time of medical bills and lifelong struggles for the child. To experience a miscarriage is devastating. Many women believe that Pfizer should have known of these risks long before they were announced by the FDA. They feel misled in assuming that fluconazole was low-risk for using during pregnancy.
These side effects are those among many that will likely lead to future lawsuits against Pfizer. Plaintiffs are expected to file soon and if you were impacted by the side effects of fluconazole you could be involved. Women affected are likely to seek monetary damages and to accuse Pfizer of negligence, failure to test their products, and failure to warn patients of risks.