The FDA and Chronic Candida
The FDA's role investigating Adverse Drug Reactions (ADRs)
The FDA has jurisdiction over the regulation of prescription drugs in the United States. In addition to approving new drugs, the FDA can withdraw a drug or change it's labeling information after it's on the market. It conducts post-marketing drug surveillance, receiving and analyzing reports of Adverse Drug Reactions(ADRs).
Chronic Candida as an ADR
All descriptions of chronic candida/Candida-Related Complex (CRC) suggest it occurs following long-term exposure to broad-spectrum antibiotcs. For example, many case reports claim symptoms first appeared after several months of use of tetracycline for acne. Tetracycline is known to cause vaginal yeast (candida) infections, as well as to increase candida numbers in the GI tract, so there is a scientific basis to suspect an association.
Licensed physicians are reporting this to their patients and, in some cases, the mainstream press or in books they've authored (such as "The Missing Diagnosis" and "The Yeast Syndrom"). If they believe antibiotics are causing the symptoms they see in their patients, then the symptoms are a side-effect (or adverse drug reaction) of the antibiotics. The FDA is responsible for investiging new ADRs, and if they find cause, change drug inserts to include additional warnings.
The off-label use of prescription drugs refers to use in the practice of medicine for purposes, or at dosages, they were not approved for by the FDA. The FDA does not endorse any of these uses, and actually discourages them. When patients are treated with a drug for off-label use, they are not informed by their physician.
Off-label drug therapies are usually based on scientific research, but it is left up practicing physicians (and recommendation of of various medical specialty societies) to police themselves as far as what is "safe and effective". If new and significant ADRs occur as a result of off-label use, the FDA must investigate and possibly add warnings about the ADRs.
The FDA's Response to Chronic Candida
People suffering from the symptoms attributed to CRC, following long-term use of antibiotics, might wonder why chronic candida is not listed among the warnings on the package insert of the antibiotics they used.
I made a Freedom of Information Act request of the FDA (on Dec. 6th, 1999) which asked if they have investigated claims 1,2 that antibiotics are causing CRC. They responded on September 30th, 2002, that there are no records of any inquiry into antibiotics causing Chronic Candida.
This means the FDA has not shown that antibiotics do not cause chronic candida. Rather, they haven't looked into, so it hasn't been proven one way or the other. If patients with the symptoms of "chronic candida" believe they were caused by prior antibiotic use, and may wish to file an ADR report through MedWatch.
Text of Freedom of Information Act Request
Below is the full text of a Freedom of Information Act request for records sent to the FDA on Monday, December 6th, 1999. They replied on Sept. 30th, 2002, saying they have no records of any investigation into chronic candida.
Freedom of Information Act request Food and Drug Administration Freedom of Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20857 fax: (301) 443-1726Monday, December 6th, 1999 Name, address, and phone number of requester(a consumer): Christopher Gregerson xxxx Beard Ave S. Minneapolis MN 554xx phone (612)xxx-xxxx Description of records being sought:
Records of all investigations made into claims in books from the lay press on "chronic candida"(1-6) (also known as "the yeast syndrome" and "candida-related complex"(7)) that prescription antibiotics(8) are causing the side-effects described in those books(9). Fees willing to pay: Limit of $75.00 Note to FOIA staff:
Please contact me by email(email@example.com) or phone(612-xxx-xxxx) if you have any questions about the records I'm seeking. Thank you for your assistance,
Chris Gregerson References: 1. C. Orian Truss, MD "The Missing Diagnosis", The Missing Diagnosis Inc, 1983(ISBN 0961575808) 2. William Crook, MD "The Yeast Connection: A Medical Breakthrough", Random House Inc, 1983 (ISBN 0394747003)(this book was a bestseller, with more than 1 million copies in print) 3. John Parks Trowbridge, MD, Morton Walker, DPM "The Yeast Syndrome, How to Help your Doctor Identify and Treat the Real Cause of your Yeast-Related Illness", Bantam Books, 1986(ISBN: 0553277510) 4. William Crook, MD "Chronic Fatigue Syndrome and the Yeast Connection: A Get-Well Guide for People With This Often Misunderstood Illness--And Those Who Care for Them", Professional Books 1992(ISBN: 0933478208) 5. Christine Winderlin, Keith Sehnert MD "Candida-Related Complex, What Your Doctor Might Be Missing", Taylor Publishing Co, 1996(ISBN: 0878339353) 6. William Crook, MD "The Yeast Connection Handbook", Professional Books, 1999(ISBN: 0933478240) 7. "The yeast syndrome", "candida-related complex", or "chronic candida" are not to be confused with "chronic mucocutaneous candidiasis", a different condition sometimes shortened to "chronic candidiasis"; also not to be confused with "systemic candidiasis", which refers to disseminated infections by the same organism(candida), or various superficial candida infections(such as candida vaginitis and thrush). 8. The use of tetracycline as a long-term treatment for facial acne is cited specifically as one cause of these symptoms. 9. Symptoms listed usually include severe fatigue, gastrointestinal symptoms, and emotional/mental symptoms(difficulty concentrating, depression). These persist beyond the exposure to the antibiotics.
Last updated on: 2010-11-05
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