FDA votes on psychiatric drug approval for children
WASHINGTON The Food and Drug Administration is reviewing three antipsychotic drugs for use in children ages 10 to 17, despite side effects that can lead to greater risk of diabetes.
According to the Associated Press, AstraZeneca, Eli Lilly and Co. and Pfizer’s drugs are currently approved for treatment of schizophrenia and bipolar disorder in adults. Although the medications have said to be equally effective amongst children, the FDA shares concern for side effects, including weight gain, increased blood pressure, sleepiness and higher risk of diabetes.
On Tuesday, the companies presented data from a three- to six-week study in which the drugs were compared to placebo. FDA and representatives of the Patient and Consumer Coalition, however, remain unconvinced and critique that research must include possible long-term effects of the antipsychotic drugs.
“We need to hold these drugs to higher standards,” said Stephanie Portes-Antoine of the Patient and Consumer Coalition at Tuesday’s meeting. “They should be proven safe and effective for long-term use since the treatment will be long-term.”
FDA will ask 10 members of its psychiatric advisory committee to discuss the benefits and risks of each medication, followed by the opportunity to vote on the issue. Though FDA is free to diverge from the panel’s advice, they typically do not.
Aurora Health Care to honor cancer survivors
MILWAUKEE With more people diagnosed with cancer every year but more of them surviving, a nonprofit healthcare system in eastern Wisconsin plans to honor cancer survivors.
Aurora Health Care, which runs the Aurora Pharmacy chain as well as a network of hospitals and clinics, announced Tuesday that it would mark National Cancer Survivors Day on Saturday with several events in three Wisconsin cities.
“There has been great progress in cancer prevention, early detection and treatment that has resulted in ever-increasing numbers of survivors,” Aurora Health Care VP cancer services Joseph Mirro said. “Now that more patients are being cured of their cancer and living longer, there’s a growing number of survivors with unique needs.”
Events will include a walk and run for cancer in Milwaukee, a gathering in Sheboygan and booths offering cancer screenings and information in Oshkosh.
FDA gives tentative approval to generic breast cancer treatment
ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a generic drug for treating breast cancer.
The drug, Roxane Labs’ letrozole tablets in the 2.5 mg strength, is a generic version of Novartis’ Femara.
Femara had global sales of $1.13 billion in 2008, according to Novartis financial data. Novartis’ patent on the drug will expire in 2011, according to the FDA’s Orange Book.