Being Alive 1997 Jul 5: 4
In letters to doctors and health care providers nationwide, the
U.S. Food and Drug Administration has warned that thousands of
people with hiv/aids taking protease inhibitors should be
closely watched for an unexpected side effect: diabetes.
The FDA stressed that the estimated 150,000 Americans taking
protease inhibitors should not stop, because the diabetes risk
appears fairly small. But the FDA, investigating after
complaints from pioneering aids researcher Dr. Michael Gottlieb
and from Japan's drug regulators, discovered 83 patients who
contracted diabetes or high blood sugaror had those diseases
suddenly worsenafter they began taking protease inhibitors. Six
cases were life-threatening, and 21 other patients needed
The FDA called the cases disturbing enough that it is
relabeling all four protease inhibitors now sold in the United
States to warn about the potential side effect. And the agency
urged patients to immediately report to a doctor such symptoms
as increased thirst, unexplained weight loss, increased
urination, fatigue and dry, itchy skin.
As many as 1 in 1,000 patients who take protease inhibitors may
be at risk, said FDA medical officer Dr. Jeff Murray. Many of
those may be treated for diabetes successfully without stopping
their aids therapy, he said. But half of the 83 patients
discovered so far had to quit taking protease inhibitors, which
have revolutionized aids care in the last year.
"I don't take this as a cause for alarm," said Dr. Sandra
Palleja of Hoffman-La Roche, maker of the nation's first
protease inhibitor, Invirase. "It just says we need to be
vigilant when we monitor patients."
The surprise warning comes just as the government is completing
its first guidelines on how doctors and patients should use the
complicated protease inhibitors. (See page 4.)
The problem: It is unclear how, biologically, protease
inhibitors would cause diabetes, which develops when the body
cannot properly use sugar for energy and glucose builds up in
the blood. It is treatable with diet, oral drugs and/or daily
shots of insulin, but can be deadly if people do not know the
warning signs and get medical help.
The 83 patients are not proof that protease inhibitors alone
actually cause diabetes, the FDA cautioned. Some of the
patients were taking, in addition to the aids medicines, other
drugs that have been associated with the disease.
On average, diabetes symptoms struck about 76 days after
patients began taking protease inhibitors, although some
patients had the first symptoms a mere four days into
Published by We The People Living with AIDS/HIV of the Delaware