THE BLOG
09/08/2010 12:11 pm ET | Updated Nov 17, 2011

Unapproved Drugs Mixed With HIV Medications Can be a Risky Prescription

Earlier this year, the Food and Drug Administration (FDA) added an arrow to proverbial medical quivers in the ongoing war on HIV and AIDS: updated warnings on interactions between HIV-medications and non-HIV drugs. The warnings specify that some drugs, when used in combination with HIV medications, may dilute the HIV drugs' effectiveness, or even cause harm to the patient.

The new labeling requirement is welcome news. But it does not account for an ongoing threat to the health and safety of HIV/AIDS patients: the continued prevalence of unapproved and unregulated drugs. These 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.

Let's back up. Today, where do we stand in the fight against AIDS? According to Avert, an international AIDS charity, nearly 36 million people still live with AIDS today -- a number that grows year after year, particularly in parts of Africa. In the US, the number of new HIV infections reported annually has "remained relatively stable," according to the Centers for Disease Control and Prevention (CDC).

One of the reasons that HIV cases in the US have stabilized is the availability of "protease inhibitors" -- HIV medicines that treat or prevent infection by viruses, thus slowing or even preventing the evolution of HIV into AIDS.

But as any pharmacist can tell you, some drugs work entirely differently (or, not at all) when used in combination with other drugs. Take Viagra, used for erectile dysfunction, and Nitroglycerin, used to alleviate chest pain by increasing blood flow to the heart. Used alone and as prescribed, both of these drugs are safe and effective. Used in combination, they can cause a fatal heart attack.

The same is true for HIV drugs. The FDA's updated warnings as to drug-to-HIV-drug interactions are now required labeling. But HIV/AIDS patients should still be vigilant, because the requirements only apply to FDA-approved drugs. 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.

Consider, for example, the 45,000 rogue Internet pharmacies identified by LegitScript. The vast majority of these sell versions of Cialis and Viagra -- the active ingredients of which are included in the FDA's warnings for HIV/AIDS medications -- without a prescription or the HIV drug interaction warnings required by the FDA. 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.

Another concern exists offline: the continuing prevalence of "unapproved drugs" that have not been subjected to the FDA review process. As such, the drugs may or may not be safe and effective -- and may present additional risks for patients with compromised immune systems, such as those with HIV.

Take colchicine, for example. Only one version of the anti-gout medicine, called Colcrys, is approved by the FDA, although numerous unapproved versions remain available in the US. Colchicine is one of the drugs included in the FDA's HIV/AIDS drug interaction warnings. Unapproved versions of colchicine not only have unproven safety and efficacy standing alone, but present unknown dangers when used in combination with HIV/AIDS medicines. They also lack the warning labels informing physicians, pharmacists and HIV patients about interactions with other drugs.

As the international battle against HIV and AIDS continues, the availability of FDA-approved drugs is a critical weapon in turning the tide in patients' favor. But the FDA, patients, physicians and pharmacists alike must be vigilant. Unregulated and unapproved pharmaceuticals, both online and offline, are not merely a danger when used alone. But, when used in combination with HIV medicines, the mixture can be equally risky, causing immediate harm or diluting the effect of the HIV drug. That's why the continued targeting of "rogue" online pharmacies, and swift removal of unapproved drugs from the marketplace, is an important part of putting patients first.