FDA requests changes in product information for all antiretrovirals

A recent letter to the manufacturers of antiretroviral drugs from the Food and Drug Administration (FDA) requests those manufacturers to update product information package inserts to include information about body fat changes.

The letter, from the FDA’s Division of Antiviral Drug Products, states that “all approved antiretrovirals should include information on fat redistribution in the package and patient package inserts.” Even product information that already mentions such changes must be updated because of the addition of facial wasting as a symptom and the change in wording from “protease inhibitors” to “antiretroviral therapy.”

The following changes were outlined in the letter.

Under the PRECAUTIONS section: “Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.”

Under the PRECAUTIONS section, Information for Patients: “Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time.”

Under the ADVERSE EVENTS section: “Body as a Whole: redistribution/accumulation of body fat (see PRECAUTIONS, Fat Redistribution).”

In the patient package insert: “Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.”

Source: HIV Treatment ALERTS!


It is refreshing that the FDA recognises that these problems arise with all antiretrovirals treatments. Perhaps this will dissuade the current tendency of pharmaceutical companies trying to make commercial advantage out of the morphologic suffering of patients, encouraging risking loss of virological control for no gain.

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