The FDA has announced that the prescribing information for haloperidol (Haldol, generic versions) has been revised to include a new cardiovascular subsection in the Warnings section.
Life-threatening arrhythmias (e.g., sudden death, QT prolongation, torsades de pointes) have been reported in patients treated with haloperidol, especially when the drug is administered intravenously or at doses higher than recommended.
Important revisions have been made to the Contraindications, Warnings, and Dosage and Administration sections of the full prescribing information for ceftriaxone (Rocephin, Roche).
This new information addresses the interaction of ceftriaxone with calcium-containing products based on reports of fatal cases in neonates. Although no cases of ceftriaxone-calcium precipitates in patients other than neonates have been reported, the potential for this inter action exists in patients of any age.
For the first time in a decade, the National Asthma Education and Prevention Program has updated clinical guide lines for the diagnosis and management of asthma. New features include:
• an expanded section on asthma for children 5 to 11 years of age.
• information on medications.
• recommendations for patient education other than in a physician’s office.
• advice for controlling environmental factors that can cause symptoms of asthma.
The nasal influenza vaccine FluMist (MedImmune) is now approved to in clude children between two and five years of age. Approval had previously been limited to healthy children five years of age and olderand to adults up to age 49. The vaccine contains a weakened form of the live virus and is sprayed into the nose.
The FDA has approved raloxifene drags HCl (Evista, Eli Lilly) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
As a selective estrogen receptor modulator (SERM), raloxifene may act by blocking estrogen receptors in the breast.
Evithrom (Omrix), a blood-clotting protein used to help control bleeding during surgery, is the first human thrombin approved since 1954.
Evithrom is indicated when control of bleeding by standard surgical techniques is ineffective or impractical. The productis applied to the surface of bleeding tissue. It may also be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels.
A new vaccine has been licensed to protect people against smallpox. ACAM 2000 (Acambis) is indicated for the inoculation of those at high risk of exposure to smallpox, and it can be used in the event of a bioterrorist attack. It will be inland Prevention’s (CDC’s) strategic national stockpile of medical supplies. The CDC considers the vaccine a Category A agent, with smallpox representing one of the greatest potential threats for harming public health.