Allen D. Seftel, MD
Head, Division of Urology
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a health care professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
Many patients are interested in these OTC drugs for a variety of personal reasons. Patients often ask the physician for advice about these OTC medications. Due to the limited data available about these medications, physicians are often reluctant to offer any medical advice to the patient, and patients appear frustrated that physicians are not providing a great deal of advice about them. The following case illustrates why physicians are unenthusiastic about providing advice regarding OTC medications.
On September 11, 2015, The One Minute Miracle Company, North Miami Beach, Florida, voluntarily recalled all lots of Miracle Rock 48 capsules. This OTC product was recalled due to an FDA analysis revealing that this dietary supplement contained undeclared drug products making them unapproved drugs.
Miracle Rock 48 capsules were marketed as a dietary supplement for male sexual enhancement and wer packaged in two blister packages of two-count capsules, four capsules per box. Miracle Rock 48 was found to contain undeclared thiosildenafil. Thiosildenafil is an analogue of sildenafil, which is an approved drug used for the treatment of male sexual enhancement. Based on the similarity of chemical structures in thiosildenafil, this analogue of sildenafil is likely to have a similar pharmacological effect as sildenafil. There is a reasonable probability use of this dietary supplement along with nitrates could cause a sudden and significant drop in blood pressure that may be life threatening.
This recall serves to remind us all that the OTC medicine world should be taken seriously, and reaffirms the reason that physicians are unwilling to provide advice regarding these OTC medications.