Week 17!

DIABETES CAN BE SIDE EFFECT OF NEW AIDS TREATMENT.(Front)

The Wisconsin State Journal (Madison, WI) June 12, 1997 The government warned doctors Wednesday that thousands of patients taking the powerful new AIDS drugs called protease inhibitors should be closely watched for an unexpected side effect: diabetes. in our site nexium side effects

In letters nationwide, the Food and Drug Administration 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 sugar — or had those diseases suddenly worsen — after they began taking protease inhibitors. Six cases were life-threatening, and 21 other patients needed hospitalization.

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 Wednesday 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 to 1 in 100 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. here nexium side effects

According to a draft obtained by The Associated Press, the standard of AIDS care should be one protease inhibitor — either Roche’s Invirase, Merck & Co.‘s market-leader Crixivan, Abbott Laboratories’ Norvir or Agouron Pharmaceuticals’ Viracept — taken in combination with two older AIDS medicines.

How and when to use these potent drugs has proved a mystery for many doctors, and AIDS groups were horrified recently to discover patients still taking the granddaddy AIDS drug AZT alone, which merely causes the fatal virus to resist treatment. Nor do many patients know each drug’s quirks — that Crixivan, for instance, must be taken on an empty stomach to work.

Among the guidelines, which the government expects to publish next week:

Test the HIV in patients’ blood every few months, and consider changing therapies if HIV is still detectable after six months.

When changing therapy, switch to at least two drugs the patient has never used, not just the one-drug switch doctors typically try today.

Avoid switching from Crixivan to Norvir or vice versa if therapy has failed; cross-resistance is likely.

No patient should be on single-drug therapy. Substituting the drug nevirapine in the medical cocktail or taking just two drugs instead of three “should be used only if more-potent treatment is not possible.” Advise patients that stopping drug treatment for even several weeks could render the drugs useless when therapy restarts. Protease therapy costs about $12,000 a year per patient, and many patients struggle to afford continual treatment. Mississippi just cut over 600 poor HIV-infected patients out of a program that provided the drugs, because the state was not receiving enough federal money to keep up with demand.

Those guidelines will come just as doctors are advising patients about the FDA’s diabetes warning.

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 other drugs that have been associated with the disease.

You may also enjoy:

• Pregnancy Glucose Screening
• Week 24!
• Week 22