Article Content

First generic topamax to prevent seizures

The FDA has approved the first generic version of topiramate (Topamax) tablets to prevent seizures. Topiramate tablets in several different strengths have been approved to be marketed by many different firms, which are listed on the FDA's Web site (


Prescribing information for generic topiramate is different from Topamax because some uses of Topamax are still protected by patents and exclusivity. The labeling for Topamax and generic topiramate contains an important safety warning about metabolic acidosis, which can cause tiredness, loss of appetite, cardiac dysrhythmia, and impaired consciousness. The patient's serum bicarbonate level should be monitored.


Topiramate has been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye causing increased intraoccular pressure. Patients taking topiramate should be instructed to contact their healthcare professional immediately if they experience vision loss or eye pain. These problems can lead to blindness if not treated immediately.


New treatment for uncomplicated malaria

The FDA has approved Novartis's artemether and lumefantrine (Coartem) tablets for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least 5 kilograms (approximately 11 pounds). It is not approved for the treatment of severe malaria or to prevent the disease.


Coartem has been proven effective in geographical areas with reported resistance to chloroquine. Coartem should be taken with food, particularly food that contains fat, because it allows the body to absorb the drug well.


The most common adverse reactions observed in clinical studies of the drug in adults were headache, anorexia, dizziness, athenia, arthralgia, and myalgia. The most common adverse reactions in children were fever, cough, vomiting, loss of appetite, and headache.


Alert: ceftriaxone and calcium-containing meds

The FDA has updated an alert concerning the interaction of ceftriaxone (Rocephin and its generics) with calcium-containing products, which was based on previously reported fatal cases in neonates.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

Ceftriaxone should not be used in neonates (less than 28 days old) if they are receiving or are expected to receive calcium-containing I.V. products.


Ceftriaxone must not be administered simultaneously with I.V. calcium-containing solutions via a Y-site in any age group. The FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients over 28 days of age, using the precautionary steps because the risk of precipitation is low in this population.


Three indications for once-monthly anti-TNF

Centocor Ortho Biotech has received FDA approval of golimumab (SIMPONI) for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis, and active ankylosing spondylitis. SIMPONI is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers patients an effective once-monthly treatment option.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

The new drug is a 50 mg subcutaneous injection given once monthly and is indicated in combination with methotrexate for the treatment of adult patients with moderately to severely active RA; alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis; and for the treatment of adult patients with active ankylosing spondylitis. SIMPONI is available as a prefilled syringe or in the SIMPONI SmartJect, a new autoinjector designed for arthritis patients.


The most common adverse reactions to SIMPONI include upper respiratory tract infection, sore throat, and nasal congestion. Like other TNF-alpha blockers, SIMPONI labeling includes a boxed warning alerting patients and healthcare professionals to the risk of tuberculosis and invasive fungal infections with use of the drug.