FDA approvals - Ezetimibe - Teriparatide

Author: Carrie Morantz, Brian Torrey
Date: March 15, 2003

* Ezetimibe. The U.S. Food and Drug Administration (FDA) has approved ezetimibe (Zetia) for cholesterol reduction. Ezetimibe is the first in a new class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol. The dosage of ezetimibe is 10 mg once daily. It can be used by itself or in combination with statins in patients with high cholesterol in order to reduce LDL cholesterol and total cholesterol levels. The patient also should follow an appropriate diet and exercise program.

Ezetimibe should not be taken by people who are allergic to any of its ingredients. When combined with a statin, ezetimibe should not be taken by anyone with active liver disease or unexplained persistent liver enzyme elevations. In addition, liver function tests should be performed at the start of therapy and after that in accordance with the label for the particular statin. Liver function tests are not required when ezetimibe is used alone.

Ezetimibe is not recommended for patients with moderate or severe hepatic insufficiency.

The most frequent adverse events reported in clinical trials were back pain, abdominal pain, and arthralgia, according to the manufacturer.

* Teriparatide. The FDA has approved teriparatide (rDNA origin) injection (Forteo) for the treatment of osteoporosis in postmenopausal women at high risk for fractures. The drug also was approved for use by men with primary or hypogonadal osteoporosis who are at high risk for fractures.

Teriparatide is the first drug in a new class of bone formation agents that work primarily by increasing the number and action of osteoblasts. The drug will be available in a disposable pen device that patients can use for self-injection. Teriparatide should be taken for up to two years.

In clinical trials, teriparatide appeared to increase leg cramps and dizziness. The most frequent treatment-related adverse events were mild, similar to placebo, and did not require discontinuation of therapy.

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