December 18, 1998
Web posted at: 9:14 p.m. EST (0214 GMT)

WASHINGTON (CNN) -- The Food and Drug Administration on Friday approved Ziagen, a new drug that has been shown to help lower HIV in the blood.

The oral medication is taken twice a day. When used in combination with other HIV medications, the FDA says it can cut levels of HIV, the virus that causes AIDS.

Ziagen is the 15th drug approved in the United States to treat HIV. The virus is very effective at mutating, so doctors and patients need as many options as possible for switching when one drug or another is no longer effective.

At least 5 percent of patients have a serious side effect to the drug -- a hypersensitivity, or allergic reaction, that can be fatal.

During clinical trials, there were eight deaths in people taking the drug, possibly attributed to this hypersensitivity. Symptoms include skin rash, fever, nausea, abdominal pain and severe tiredness.

The FDA is setting up a registry to monitor the hypersensitivity reaction in patients.

"Anyone who experiences a hypersensitivity reaction must stop taking the medicine and call their health care provider immediately," the FDA says. "Ziagen should not be taken again after a reaction occurs because more severe symptoms will arise within hours and may include life-threatening low blood pressure or death."

Other less-severe side effects include nausea, vomiting, fatigue, headache, diarrhea and loss of appetite.

Ziagen is in the class of drugs called nucleoside analogue reverse transcriptase inhibitors (NRTIs), the same class as AZT. It is the first new drug in its class to be approved in more than three years.

Glaxo Wellcome, the drug's maker, said it should be on the market in early January. It will cost $9.70 per day wholesale or about $3,540 a year.