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Unapproved Drugs Mixed With HIV Medications: A Risky Prescription

LegitScript’s President blogged in the Huffington Post today about the risk mixing drugs that are not FDA-approved with HIV medications such as protease inhibitors.

As noted in the blog, the danger to HIV patients is:

…(that unregulated) drugs, sold by fly-by-night “rogue” Internet pharmacies located overseas, and even by walk-in pharmacies here in the US, can pose real danger when mixed with HIV medications.

Earlier this year, the FDA mandated updated warnings on interactions between HIV-medications and non-HIV drugs. This is an important step, because HIV medications become ineffective when mixed with some other drugs. The risks extend to both rogue online pharmacies as well as the dispensing of unapproved drugs by offline (brick-and-mortar) pharmacies:

Online, “rogue” Internet pharmacies often tout unregulated, substandard or adulterated prescription drugs as being FDA-approved. Offline, some pharmacies continue to offer unapproved versions of drugs where there is an approved equivalent version. These unapproved drugs have not been subjected to FDA review, do not contain the required warnings about interactions with HIV medicines, and may interact negatively with HIV medications.

As one example, the vast majority of rogue online pharmacies sell illicit versions of Cialis and Viagra, typically without a prescription. But:

The active ingredients of (Cialis and Viagra) are included in the FDA’s warnings for HIV/AIDS medications…in some cases, the drugs contain levels of active ingredients, sometimes, far more than normal, that are unsafe when used in combination with HIV medications.

There are a few prescription drugs that have not been subjected to the FDA’s drug review and approval process, and for which no approved alternative exists; where these have been on the market for years with no known side effects, it is reasonable to continue making those drugs available in order to ensure that patients have access to needed medications. Where an approved version of the drug is available, however, patients, pharmacies and physicians alike should ensure that they are being provided the FDA-approved version of the drug, as opposed to a version that has not been determined to be safe and effective.