LIGAND PROMOTIONAL MATERIALS LACKED SERIOUS RISK INFORMATION, FDA SAYS

Promotional materials for two of Ligand's cancer drugs are misleading because they lack risk information for the drugs, overstate their effectiveness and broaden their indications, the FDA said in a warning letter.

Ligand must stop using the marketing materials for Ontak and Targretin because they leave out significant warnings, adverse reactions and precautions for both drugs, the warning letter said. The violations were considerable enough that the FDA also requested Ligand create a plan of action to send "truthful, non-misleading and complete corrective messages" to anyone who received the original materials.

Both drugs carry the risk of serious side effects, the FDA said. Approved labeling for Ontak notes that taking the drug may impair immune systems in patients. Also, all patients in one FDA-approved study who took the drug experienced one or more adverse events, including chills, infection, nausea and anorexia.

In another study, 21 percent of patients required hospitalization after an Ontak-related adverse event, and 5 percent of those reactions were severe or life-threatening. None of this information was included in Ligand's promotional materials, the warning letter said.

One promotional piece said Ontak was "generally well-tolerated," according to the warning letter. The FDA noted that term is "not appropriate for drugs associated with frequent and serious events, such as this product."

Ligand did not respond to a request for comment by press time.

The warning letter can be viewed at www.fda.gov/cder/warn/2006/Ontak-Targretin-promo.pdf (http://www.fda.gov/cder/warn/2006/Ontak-Targretin-promo.pdf).