FDA Warnings Nurses can Include in Patient Education

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The Food and Drug Administration (FDA) frequently offers warnings regarding the safety of over-the-counter (OTC) or unapproved consumer products. Here are some recent warnings that nurses should consider when providing patient education.
PNC-27 as cancer treatment. The FDA is warning consumers not to purchase or use a nonapproved product called PNC-27, after the agency's laboratory found the bacteria Variovorax paradoxus in some samples (see www.fda.gov/Drugs/DrugSafety/ucm536094.htm). PNC-27 is promoted and sold by international sources on the Internet as a treatment for cancer. V. paradoxus, a gram-negative, aerobic bacteria found in soil, is involved in plant growth promotion and biodegradative processes in nature. The FDA considers this bacteria to be a potentially life-threatening contaminate for people with weakened immune systems, such as those with cancer.
PNC-27 has a novel mechanism that could be used in targeted cancer therapy. According to studies available on the PNC-27 Web site (http://PNC27.com), the mechanism is a membrane-active peptide that creates holes in the membrane of the cancer cell and kills it. The Web site highlights the work of American scientists researching this potential drug. While the work of these scientists is reputable, their research describes in vitro laboratory studies and not completed clinical trials, as the Web site suggests. (The materials on the site do not indicate endorsement of the drug by these scientists.) The Web site appears to be a lure for consumers to purchase the drug, either by coming to a Mexican clinic or by receiving “home therapy,” as well as for physicians who work outside the United States to purchase the drug for resale to patients.
Belladonna in baby teethers. The FDA has issued a consumer alert that some homeopathic teething tablets contain varying amounts of belladonna, a highly toxic substance from the poisonous plant of the nightshade family, with some products far exceeding the amount of belladonna claimed on the label.
Belladonna contains active components of atropine, scopolamine, and hyoscyamine, all of which are anticholinergics. These anticholinergic properties block the effects of the parasympathetic nervous system, producing a wide variety of adverse effects, including dilated pupils, blurred vision, tachycardia, loss of balance, severe dryness of the mouth and bronchial tree, skin flushing, difficulty eliminating urine or stool, slurred speech, confusion, agitation, hyperthermia, hallucinations, and convulsions. Despite its known toxicity, belladonna has been used for centuries in herbal medicine to relieve pain, as well as for other indications. Belladonna is not approved by the FDA, and the agency does not evaluate homeopathic teething products for safety or effectiveness. The FDA cannot restrict belladonna's use if it is sold in homeopathic or other OTC preparations that do not claim to treat or diagnose an illness or medical condition.
The FDA is concerned about the effects of belladonna exposure and potential poisoning in infants and young children. The specific products found to contain belladonna are Hyland homeopathic teething products manufactured by the Standard Homeopathic Company in Los Angeles. This is not the first time the FDA has warned of belladonna in Hyland's teething products; a similar consumer safety alert was posted in October 2010. The agency also issued a similar warning in November 2016 of belladonna in teething products made by Raritan Pharmaceuticals in East Brunswick, New Jersey. The FDA is currently investigating reports of adverse effects concerning belladonna in teething products, and more information will be released at the end of that analysis. (For more, see http://bit.ly/2mfpkof.)
Nurses should assess whether parents use homeopathic products such as these to minimize their infants’ pain from teething. Parents who use these products should be alerted to the risk of belladonna poisoning and encouraged to discard them.
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