Black box warnings for two eczema creams

Jan 22 2006

Food and Drug Administration officials in the U.S. have announced that two prescription creams to treat eczema will now carry strong warnings about the possible risk of skin cancer, lymphoma and other cancers.

The manufacturers of the creams, Elidel (Novartis) and Protopic (Astellas Pharma), say the creams will now carry a "black-box" warning -which is the strongest type used in the United States.

The announcement comes 10 months after the agency first demanded them.

According to the FDA although a clear link between the drugs and a heightened cancer risk had not been found, there have been enough cancer reports to warrant the change.

Up to October 2005, a total of 78 cases were reported for both products.

Dr. Julie Beitz, an acting office director within the FDA's office of drug evaluation, says there is concern as the long-term safety of the products has not been established.

The labels will also include changes which make it clear that both treatments are only to be used after other drugs have failed and are not recommended for children younger than 2 years old.

Eczema is a rash-like inflammation that causes itchy, red skin, and it can also be treated with antihistamines, oral and topical steroids and over-the-counter products.

Both drug companies continue the defence of the safety their drugs but have agreed to make the change anyway after months of negotiation with the FDA.

Novartis says that it does not believe the action is substantiated by scientific or clinical evidence, but has agreed to make the requested changes and will communicate them to physicians and patients.

Astellas vice president for research and development, Joyce Rico also says the data did not show a clear link between the drugs and cancer risk had been found .

She says she believes that Protopic is a safe and effective medication when used as prescribed, and that the causal relationship with lymphoma has not been documented.

The new warnings come after the agency called for the change in March, one month after its panel of outside experts recommended them.

At that time, Novartis disputed the request.

Beitz says the agency then had to create an internal review panel to reassess all of the data, which took time in order to clearly understand what the data was saying.

She says the FDA recognized the companies disagreed with its analysis.

Novartis and Astellas, are now conducting long-term safety studies for their products, however the FDA was not prepared to wait for what could be many years for those results before taking action.