Drugs and Devices

Drugs Today – June 2009

New arthritis drug approved

The Food and Drug Administration (FDA) has approved golimumab (Simponi) for active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. Given subcutaneously, it’s the first patient-administered antitumor necrosis factor-alpha therapy available as a once-monthly treatment option (50 mg). The drug is indicated in combination with methotrexate for adults with moderately to severely active rheumatoid arthritis, and either alone or combined with methotrexate for adults with active psoriatic arthritis. It comes in two dosage forms—a prefilled syringe and an autoinjector designed specially for arthritis patients.

www.simponi.com/simponi/Healthcare-Professionals/index.html

Ceftriaxone can be used with calcium in patients older than 28 days

In a recent update for physicians, the FDA stated that ceftriaxone can be used concomitantly with I.V. calcium-containing products in patients older than 28 days. In 2007, the agency warned clinicians not to give the drug and calcium-containing products within 48 hours of each other because of the potential for precipitation. But based on vitro study results, the FDA determined the precipitation risk is low in all patients except neonates. Concomitant use is still contraindicated in neonates, and ceftriaxone shouldn’t be given if they are receiving (or are expected to receive) calcium-containing I.V. products. In patients older than 28 days, ceftriaxone and calcium-containing products may be given sequentially if the lines are thoroughly flushed between infusions with a compatible fluid. In patients of any age, ceftriaxone must not be given simultaneously with calcium-containing solutions via a Y-site.

www.fda.gov/cder/drug/InfoSheets/HCP/ceftriaxone042009HCP.htm

Psoriasis drug voluntarily pulled from market

After June 8, efalizumab (Raptiva), used to treat moderate to severe psoriasis, won’t be available in the United States because it has been linked to an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal neurologic disease. Clinicians shouldn’t write prescriptions for new patients and should promptly contact patients currently receiving the drug to discuss appropriate therapeutic alter­natives. Severe psoriasis may worsen when the drug is withdrawn abruptly, so patients must consult their healthcare pro­viders before stopping treatment. Genentech, the drug’s manufacturer, updated prescribing information last October to include a boxed warning on the risk of PML and other serious infections, and again in March to include additional information on the PML risk. In February, the FDA issued a public health advisory about Raptiva. Three PML cases have been confirmed in patients receiving the drug.

www.gene.com/gene/products/information/immunological/raptiva/index.html


www.fda.gov/cder/drug/advisory/efalizumab.htm

FDA deems Seroquel XR safe for depression but not for anxiety

An FDA panel has found that the atypical antipsychotic Seroquel XR (quetiapine fumarate) can be used safely when given in combination with other drugs to treat certain patients with depression. However, it determined that the risk of serious cardiac, metabolic, and other adverse effects makes it generally unsafe as monotherapy for major depressive disorder or generalized anxiety disorder. Several panel members emphasized that clinicians should try other treatments for depression before adding Seroquel XR. The FDA will consider the panel’s ruling when deciding whether to approve the drug’s expanded use.

www.astrazeneca-us.com/about-astrazeneca-us/newsroom/all/5302755?itemId=5302755

FDA approves generic versions of Topamax

The FDA has approved generic versions of the anticonvulsant Topamax (topiramate), giving 17 companies the right to market the drug. Topiramate has been associated with metabolic acidosis, so clinicians should monitor patients’ serum bicarbonate levels during therapy. Other adverse effects include acute myopia and secondary angle-closure glaucoma. Labeling for generic topiramate will differ from that of Topamax because some uses of the drug are still protected under patents and exclusivity.

www.fda.gov/bbs/topics/NEWS/2009/NEW01984.html

Valproate use during pregnancy may impair offspring’s cognitive function

Interim results of a prospective study show impaired cognitive function at age 3 among children exposed in utero to the anticonvulsant valproate. Researchers studied pregnant women taking one of four drugs for epilepsy, and then assessed cognitive function in their offspring at age 3. Overall, the IQs of valproate-exposed children were about 6 to 9 points lower than those of children exposed to carbamazepine, lamotrigine, or phenytoin. The link between valproate and lower IQ was dose-dependent and persisted after adjustment for maternal IQ and age. The study bolsters a recommendation not to use valproate as a first-line drug in women of childbearing potential.

http://content.nejm.org/cgi/content/short/360/16/1597

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