Featured Items: golimumab (Simponi) approved for ulcerative colitis; valproate products warning for migraine prevention during pregnancy; oxymorphone HCl extended-release tablets (generic Opana-ER) continued production allowed; canakinumab (Ilaris) FDA approved for juvenile arthritis. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.
Golimumab (Simponi®) – Expanded Approval for Ulcerative Colitis
Janssen Biotech announced a May 2013 U.S. Food and Drug Administration (FDA) approval of Simponi — a tumor necrosis factor (TNF) blocker — as a subcutaneous option for the painful symptoms of ulcerative colitis (UC). It is intended for adult patients with moderate to severely active UC who have a history of corticosteroid dependence or those who have had an inadequate response to other approved pharmacotherapies.
Simponi approval was based on safety and efficacy studies of more than 800 patients who received active or maintenance treatment. Trial results at week 6 showed that a significantly greater number of patients in the treatment group, compared with placebo, achieved the predetermined clinical endpoints for objective response, disease remission, and improved colon appearance on endoscopy. In addition, a significantly greater number of patients maintained clinical remission at evaluation weeks 30 and 54 when compared with patients receiving placebo. Past FDA approvals for Simponi include the following adult indications: 1) moderate to severely active rheumatoid arthritis, as a combination treatment with methotrexate; 2) active psoriatic arthritis, alone or with methotrexate; and 3) active ankylosing spondylitis.
Because TNF blockers can lower a person's infection-fighting power, a risk-benefit ratio should be evaluated in patients who have underlying health conditions that make them prone to infection. Bacterial infections in patients taking TNF blockers, sometimes concomitantly with immunosuppressive agents, have been reported to be serious and even fatal. Healthcare providers should arrange testing for latent tuberculosis before initiating treatment and should also ask patients if they are being treated for infection. For full administration and safety instructions, please read the Simponi prescribing information.
Valproate Products for Migraine Prevention – Safety Warning During Pregnancy
The FDA released a May 2013 expanded safety communication regarding the use of any valproate product for migraine headaches in women who are pregnant. Additional data following the original 2011 FDA safety alert shows that risks to unborn children may outweigh migraine treatment benefits. A recently-published study in Lancet Neurology shows further evidence that children who have been exposed to valproate products in utero can have lower IQ scores. Products containing valproate sodium, divalproex sodium, or valproic acid include Depacon, Depakote, Depakote CP, Depakote ER, Depakene, Stavzor, and all generic forms of these medications. Boxed warnings for these agents currently warn of the fetal risk of birth defects. The FDA has changed the pregnancy risk category for the valproate product indication of migraine to Category X, indicating that the risk to pregnant women clearly outweighs any possible benefit. Pregnant women taking valproate products for indications other than migraine prevention should talk with their healthcare provider to determine if the treatment benefits outweigh the risk. Patients currently on valproate therapy should talk with their clinician before stopping the medication suddenly. See the FDA Drug Safety Communication for further details.
Generic Oxymorphone HCl-ER Tablets – Continued Sales Allowed
In their response to a petition by Endo Pharmaceuticals, the FDA made a May 2013 decision to allow marketing generic formulations of the original version of Opana-ER®, which does not have abuse-deterrent features. Endo filed the petition after their withdrawal of the original formulation and the approval of their newer crush-resistant reformulation of Opana-ER. Because the FDA evaluation of the product concluded that the original tablets were not withdrawn due to safety or efficacy issues, generic versions of the original formulation can continue to be approved and marketed. While the FDA statement indicates that the development of abuse-deterrent formulations of opioids is encouraged, their evaluation of Opana-ER concluded that the reformulated product is still able to be manipulated in ways other than crushing the tablet. For more information regarding the decision, see the FDA Statement on their evaluation of the original Opana-ER product.
Canakinumab (Ilaris®) – FDA Approved for Juvenile Arthritis
According to a May 2013 announcement by Novartis, the FDA expanded the approved indications for Ilaris to include the treatment of active systemic juvenile idiopathic arthritis (SJIA). The drug — an interleukin-1 beta inhibitor — is approved for patients aged 2 years and older and is administered monthly by subcutaneous injection. SJIA is a rare autoimmune disorder that can become disabling with symptoms of fever, rash, joint inflammation, and pain. Few treatment options exist for SJIA and a related news story (Medscape News) reported that “some experts describe canakinumab as a more benign alternative to the corticosteroids often prescribed for systemic JIA.” Canakinumab has previously been approved to treat cryopyrin-associated periodic syndromes (a spectrum of autoinflammatory syndromes). The product prescribing information alerts clinicians and users to the fact that canakinumab has been known to weaken the body's immune system which could result in an increased risk of serious infection. For further information on the study results that formed the basis for the approval, read the Novaris Media Release.
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