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Tocilizumab approved for giant cell arteritis

The FDA has expanded the approved use of subcutaneous tocilizumab (Actemra) to treat adults with giant cell arteritis. The new indication provides the first FDA-approved therapy specific to this type of vasculitis, which mainly affects the vessels of the head (especially the temporal arteries). Standard treatment involves high doses of corticosteroids that are tapered over time.


Subcutaneous tocilizumab was previously approved for the treatment of adults with moderate-to-severe active rheumatoid arthritis. The efficacy and safety of subcutaneous tocilizumab for giant cell arteritis were established in a 52-week double-blind, placebo-controlled study with 251 patients with giant cell arteritis. A greater proportion of patients receiving subcutaneous tocilizumab with standardized prednisone regimens achieved sustained remission from week 12 to week 52 compared with patients receiving placebo with standardized prednisone regimens.


The cumulative prednisone dose was lower in treated patients with subcutaneous tocilizumab relative to placebo. The safety profile of subcutaneous tocilizumab was generally consistent with the known safety profile of tocilizumab, which carries a boxed warning for serious infections.


Generic version of Strattera now available

The FDA has approved the first generic version of atomoxetine (Strattera) to treat attention-deficit hyperactivity disorder (ADHD) in pediatric and adult patients. The branded product was approved in 2002 and is one of the few approved nonstimulant ADHD treatments. Atomoxetine is a selective norepinephrine reuptake inhibitor.


In clinical trials of atomoxetine in children and adolescents, the most common adverse reactions reported were abdominal pain, decreased appetite, nausea or vomiting, fatigue, and somnolence. In adults, the most common adverse reactions included constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitancy.


Atomoxetine has a boxed warning for increased risk of suicidal ideation in children and adolescents. Patients taking this drug should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior. Other important warnings include the risk of severe liver damage and potential for serious cardiovascular events.


FDA approves cetirizine eye drops for allergic conjunctivitis

The FDA has approved cetirizine ophthalmic solution 0.24% (Zerviate) for the treatment of ocular itching associated with allergic conjunctivitis. It is the first topical ocular formulation of cetirizine, an antihistamine that is available in oral formulations for the relief of allergic symptoms.

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The FDA approved cetirizine based on data from three randomized, double-blind, placebo-controlled, conjunctival antigen challenge clinical trials in patients with allergic conjunctivitis. Two trials that evaluated onset and duration showed cetirizine was associated with statistically and clinically significant less ocular itching versus vehicle at 15 minutes and 8 hours after treatment.


One lot of oral contraceptives recalled

Lupin Pharmaceuticals has announced a voluntary recall of one lot of its contraceptive norethindrone acetate and ethinyl estradiol chewable and ferrous fumarate (Mibelas 24 Fe) tablets after a complaint of a packaging error that involved out-of-sequence tablets.

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The product is supplied as blister packs containing 24 active tablets and 4 inert tablets. The recalled product has a lot number (L600518) with an expiration date of May 31, 2018, and is packaged as a wallet of 28 tablets or a carton of 3 wallets. The report showed that the blister pack was turned 180 degrees within the wallet, reversing the weekly tablet arrangement. This would provide the first 4 days of therapy with 4 nonhormonal placebo tablets instead of the active tablets. The lot number and expiration date were also no longer visible as a result of the rotated blister pack.


The reversed order may not be obvious to first-time users or previous users, which may further increase the risk of taking the pills out of sequence, putting the user at risk for unintended pregnancy. To date, Lupin has not received any reports of adverse events. The company has notified distributors and customers via a recall letter and is arranging for return of all recalled products.