In 2016, the U.S. Food and Drug Administration (FDA) reviewed a 17-year Danish study involving both the pill and liquid versions of Diflucan or its generic version, fluconazole. The study showed that the commonly prescribed yeast infection drug, manufactured by Pfizer, can cause miscarriages; although it did not provide proof of harm. Patients who experienced a negative event while taking Diflucan or shortly after taking the medicine should report their experience to health authorities before contacting a medical malpractice lawyer.
Diflucan is prescribed to both pregnant and non-pregnant women experiencing a variety of yeast infections. Vaginal yeast infections are common among pregnant women and when they become severe or persistent, Diflucan is sometimes prescribed.
Diflucan warning labels
Before the Danish study, the drug’s U.S. label was based on FDA approved studies that showed no increased risks during pregnancy if exposed to a single 150mg oral dosage. In 2011, the FDA released a warning statement that high doses (400-800mg per day) of Diflucan could cause birth abnormalities including flattened rear skull (brachycephaly) and cleft palate; the labels were updated accordingly.
The Danish study, released in January, 2016, evaluated over one million pregnancies from 1997-2013. They compared the results for mothers who took Diflucan against the results of similar pregnancies where the mother was not exposed to the drug.
The study found a clear correlation between the mother taking Diflucan and complications in pregnancy, including miscarriages. They showed that even a standard low dose of 150mg taken one to two times per day in the first six months of pregnancy increases the risk of miscarriage by an alarming 50 percent.
Women who are pregnant or plan to become pregnant should monitor the progress of the FDA’s review of the dangers associated with this drug and check the FDA’s adverse event reports for actual events submitted by patients, doctors and researchers. Other places to check for information are the Organization of Teratology Information Specialists (OTIS), the National Birth Defects Prevention Study (NBDPS) and Pregnancy Registries, which are sometimes used for studies conducted by drug manufacturers.
Patients expect that they can rely on their doctors to prescribe drugs that are safe for them, especially when they are pregnant. Patients have a right to quality of care. If you are pregnant and in need of treatment for yeast infection it is clear that both the mother and doctor should be taking the Danish study into consideration before prescribing Diflucan. Note that the FDA has long classified Diflucan as a category D drug during pregnancy. This means that they have found scientific evidence to support that there are risks associated with its use, including birth defects. Despite this, the benefits of appropriate use of category D drugs are generally considered to outweigh the risks. If you are pregnant or planning to become pregnant, talk to your healthcare provider before choosing a medication or switching medications, even if they are over-the-counter.
If you were prescribed Diflucan when pregnant and subsequently experienced a miscarriage, pregnancy complications or birth injuries/defects contact a birth injury lawyer today. The help and support of an experienced personal injury lawyer is invaluable when bringing a case against a health care provider or drug manufacturer.
The Seattle personal injury attorneys at Morrow Kidman Tinker Macey-Cushman, PLLC have years of experience representing families harmed by medical malpractice. We seek justice for patients who have been harmed by preventable medical errors including birth injuries, hospital-acquired infections and wrongful death in Seattle and across Washington State. There are no fees or expenses to file a personal injury case as we only receive payment if we recover damages on your behalf. Do not delay; personal injury claims come with a Statute of Limitations, which means they must be filed within a certain time frame of the injury.
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