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FDA Approves Erbitux for Squamous Cell Head-and-Neck Cancer

ROCKVILLE, Md. - The FDA has approved Erbitux (cetuximab) for treatment of squamous cell head-and-neck cancer, making the monoclonal antibody the first new agent for this indication in a half-century.

FDA Approves First Antidepressant Transdermal Patch

ROCKVILLE, Md. - The FDA has approved a once-a-day antidepressant patch that delivers a monoamine oxidase inhibitor. Called Emsam (selegiline), the patch can be used at its lowest dose without the dietary restrictions that accompany oral MAO inhibitors.

FDA Warns About Risks of Throat-Numbing Spray

ROCKVILLE, Md. - The Veterans Health Administration has halted the use of benzocaine sprays to numb mucous membranes in the mouth and throat, prompting the FDA to reissue warnings about the risk of methemoglobinemia.

FDA Warns of Two Eczema Agents' Possible Cancer Risks

ROCKVILLE, Md. - The FDA reported that two popular topical eczema drugs -- Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) -- have had black-box warnings about skin cancers and lymphoma added to their labels.

FDA Says It Plans Label Changes for Concerta and Ritalin

WASHINGTON-The FDA said it plans to strengthen the warning label for Concerta, the popular long-acting version of Ritalin (methylpenidate) in response to post-marketing surveillance reports of psychiatric and cardiovascular adverse effects.

FDA Okays Single Dose Antibiotic for Pneumonia and Sinusitis

NEW YORK-The FDA has approved Zmax (azithromycin extended release) as a single-dose treatment for adults with pneumonia and certain types of acute mild-to-moderate bacterial sinusitis and pneumonia, Pfizer announced yesterday.

Crestor Called Less Safe Than Other Statins

BOSTON-Adverse event reports from the FDA suggest that Crestor is more likely to cause muscle and kidney damage than other major statins (Lipitor, Pravachol or Zocor), researchers here reported in the journal Circulation.

What a Pain! Now It's Tylenol Troubles

NOTTINGHAM, England-Acetaminophen, the popular painkiller found in Tylenol and generic analgesics, has been associated with a dose-related risk of lung disease, an effect not seen with ibuprofen (Motrin, Nuprin) and aspirin.

FDA Approves 'Gila Monster' Diabetes Drug

ROCKVILLE, Md.-The FDA announced today it has approved a new injectable diabetes drug synthesized from gila monster saliva, but says the drug should only be used in combination with older oral medications.

FDA Warns of Excess Mortality to Elderly With Antipsychotics

WASHINGTON-The FDA has issued a public health advisory on the entire class of atypical antipsychotic drugs, pointing to an apparent excess of mortality for older patients with dementia, particularly when the agents are used off-label to treat behavioral disorders.