New Indications
• Quetiapine fumarate (Seroquel; Astra- Zeneca): for the treatment of depressive episodes associated with bipolar disorder. www.astrazeneca.com

• Bortezomib (Velcade; Millennium): for the treatment of patients with mantle cell lymphoma who have received at least 1 therapy. www.millennium.com

Silicone Breast Implants Are Back
Silicone gel-filled breast implants have been approved for marketing by Allergan and Mentor for breast reconstruction in women of all ages and for breast augmentation in women aged ≥22 years. The companies will conduct a postapproval 10-year follow-up of about 40,000 women. www.fda.gov

Life-Threatening CV Events with ESA Agents
Patients treated with an erythropoiesis-stimulating agent (ESA)—epoetin alfa (Epogen, Procrit) or darbepoetin alfa (Aranesp)—are at significantly increased risk for serious and life-threatening cardiovascular (CV) complications if they are dosed to a target hemoglobin concentration of 13.5 g/dL rather than 11.3 g/dL, according to an FDA alert triggered by a recent study (N Engl J Med. 2006; 355:2085-2098). www.fda.gov

Genotyping for Warfarin Therapy
To reduce serious adverse reactions to warfarin (Coumadin), the FDA is advising genotyping patients at the start of therapy to expedite patient stabilization at safe/effective dosages. www.Genelex.com

Methadone Linked to Serious Adverse Events
Death and life-threatening events (eg, respiratory depression, cardiac arrhythmias) have been reported in patients receiving methadone (Dolophine, Methadose). These events may be due to unintentional overdoses, drug interactions, and/or methadone's cardiac toxicities (QT prolongation and torsades de pointes). www.fda.gov/medwatch

Pfizer Halts Torcetrapib Trial
In a surprising move, Pfizer suspended its much-anticipated drug torcetrapib—a novel cholesteryl-ester-transfer-protein inhibitor that was being investigated for coadministration with atorvastatin (Lipitor) to control lipid abnormalities. The addition of torcetrapib to atorvastatin resulted in an increased mortality rate in a large, phase 3 clinical trial. www.pfizer.com

New E Coli Outbreak
The new outbreak of Escherichia coli 0157 infections involving 43 individuals who had eaten food from a Taco Bell restaurant in New Jersey, New York, Pennsylvania, and Delaware has prompted an FDA investigation. Additional cases are suspected in these states and in Connecticut. Preliminary tests have indicated the possible presence of E coli 0157:H7 in lettuce samples. www.fda.gov

Compounded Anesthetic Creams Alert
The FDA has warned 5 firms to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than for the unique medical needs of specific patients.

Exposure to high concentrations of local anesthetic such as in the compounded creams can cause seizures and irregular heartbeat. Two deaths have been connected to the use of such creams manufactured by Triangle Compounding Pharmacy and University Pharmacy. Similar creams are made by Custom Scripts Pharmacy, Hal's Compounding Pharmacy, and the New England Compounding Center.

These creams contain high doses of local anesthetics, such as lidocaine (eg, LidaMantle, Xylocaine), tetracaine, benzocaine (eg, Solarcaine, Lanacane), and prilocaine. Combining these anesthetics into 1 product increased the potential for harm, especially in small children and in patients with preexisting heart conditions or liver disease. www.fda.com

Experimental Drugs for Seriously Ill Patients
The FDA has proposed regulatory changes to make experimental drugs available to severely ill patients. This would also put limits on costs for an experimental drug. Expanded access would be available under a treatment protocol or investigational new drug application. The proposal, which is open for comment for 90 days, is described at: www.fda.gov/cder/regulatory/applications/IND_PR.htm