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Lack of demonstrated safety and efficacy of probiotics in HIV patients

A recent assessment by Guinane regarding the use of probiotics to manage diarrhoea in HIV-positive patients states ‘safety and lack of drug-drug interactions [DDIs] make it [use of probiotics] a reasonable option for some patients.’ [1] While diarrhoea is a major concern in the management of HIV-positive patients, three critical issues need to be considered before suggesting that probiotics are safe and free of DDIs. First, given their regulatory classification as dietary supplements or medical foods, probiotics are not subject to the higher safety (and efficacy) requirements established for products classified as drugs or biologics by the Food and Drug Administration (FDA) and/or the European Medicines Association (EMEA). As a result, much-needed preclinical, clinical and post-marketing surveillance safety data are not required for probiotics and are extremely limited. Of concern, case reports indicate that immunocompromised patients are at higher risk for probiotic-induced sepsis, with the mechanism being translocation of the probiotic from the gut to the bloodstream or manual contamination of central venous catheters [2]. Secondly, as dietary supplements or medical foods, probiotics are not subject to metabolism characterization requirements as are drugs or biologics, nor are they subject to relevant DDI investigations. Again, this much-needed evidence is extremely limited. Preliminary studies indicate that probiotics may have metabolic effects on liver enzymes and could significantly impact drug metabolism [3]. Thirdly, the catch-all term ‘probiotics’ is equivalent to ‘antibiotics.’ Just as the safety profile and therapeutic effects of an individual antibiotic cannot be generalized to all antibiotics, the safety profile and therapeutic effects of an individual probiotic product (which, to further complicate matters, could be comprised of an individual probiotic strain or multiple probiotic strains – each strain having its own safety profile and therapeutic effects) cannot be generalized to all probiotics [4,5]. Thus, meta-analyses and reviews of probiotics to demonstrate class-wide effects are generally inappropriate. Although dietary supplements and medical foods are widely available, they can pose serious safety risks in certain patients. Given the regulatory classification of probiotics as a dietary supplement or medical food, clinicians and other health care workers must be aware that muchneeded strain-specific safety and DDI data are currently unavailable and, given the lack of requirements for industry to generate this information, will probably not emerge in the near future. Although diarrhoea among HIV-positive patients is a serious global concern for patients and physicians, the lack of evidence demonstrating the safety of, or lack of DDIs with, specific probiotics suggests the need for considerable caution in using a probiotic ‘as a reasonable option’ in the management of HIV-positive patients.