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Weekly News Round Up - February 15, 2012

Roche and FDA Work to Locate Distributed Vials of Counterfeit Avastin

FDA issues warning about counterfeit Avastin 400mg/16mL; product does not contain bevacizumab Read More...

Some medical practices in the U.S. may have purchased a counterfeit version of Avastin 400mg/16mL which does not contain bevacizumab. Avastin is approved for treatment of lung, colon, kidney and brain cancers, and is marketed by Genentech (a Roche company). The counterfeit package is labeled with the Roche logo and displays batch numbers beginning with B6010, B6011 or B86017. Nineteen U.S. medical practices purchased the counterfeit Avastin from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, TN is a distributor of QSP products. Medical practices with any product from Volunteer Distribution or QSP/Montana Health Care Solutions should stop using them, securely quarantine the products, and contact the FDA at 1-800-551-3989.

FDA: Drug Interactions Between Victrelis and Certain Protease Inhibitors

Drug interaction between Victrelis (boceprevir) and ritonavir-boosted protease inhibitors may reduce effectiveness of both Read More...

A drug interaction study has shown that Victrelis (boceprevir) interacts with ritonavir-boosted HIV protease inhibitors Reyataz (atazanavir) and Prezista (darunavir), and with combination agent Kaletra (lopinavir/ritonavir). Victrelis is a protease inhibitor used together with other medications for treatment of chronic hepatitis C virus (HCV). Reduced blood levels and effectiveness of both the HIV medications and Victrelis may occur. Healthcare providers who have patients on Victrelis and a ritonavir-boosted protease inhibitor should monitor them for lowered HCV treatment response and for HCV or HIV virologic rebound. Patients on these medications should not stop or adjust their medication regimen without first contacting their healthcare provider.

Zioptan Once-Daily Eye Drops Approved For Glaucoma, Ocular Hypertension

Zioptan (tafluprost ophthalmic solution) is a prostaglandin analog indicated for reducing elevated intraocular pressure Read More...

The first preservative-free ophthalmic prostaglandin analog, Zioptan (tafluprost ophthalmic solution 0.0015%) has been approved to reduce intraocular pressure (IOP) for patients with ocular hypertension or open-angle glaucoma. Similar prostaglandin analogs include Xalatan (latanoprost), Travatan Z (travoprost), and Lumigan (bimatoprost). These agents are often used as first-line treatments of elevated IOP. Common Zioptan side effects are conjunctival hyperemia (eye redness), stinging and itching. Pigmentation of the iris, eyelid and eyelashes can occur, and iris pigmentation may be permanent. Reversible eyelash changes, including increased length, thickness and number of lashes may occur as well. According to Merck, Zioptan U.S. launch is slated for March.

Epinephrine Autoinjector May Become More Accessible in U.S. Schools

Experts recommend epinephrine use even if suspicion of severe allergy; temporarily fast heart rate only significant side effect Read More...

There’s no clear-cut reason, but the incidence of food allergies are climbing. About 1 in 12 kids have a food allergy, with peanuts, milk and shellfish at the top of the list. Anaphylaxis in the school setting can be life-threatening if teachers and administrators are not trained in epinephrine administration. Parents are required to supply an epinephrine pen (EpiPen) to the school; however, the School Access to Emergency Epinephrine Act, introduced to the House and Senate this year, may change that. The Act, if passed, would encourage states to allow schools to have epinephrine on hand for any student who is having a serious allergic reaction.

Mitosol FDA-Approved for Use in Glaucoma Surgery

Mitosol (mitomycin for solution) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery Read More...

Glaucoma is the second-leading cause of blindness in the United States. Glaucoma is often treated in steps, with medications, laser surgery, and eye surgery, if indicated. The U.S. Food and Drug Administration (FDA) has approved Mitosol (mitomycin for solution), an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. Mitosol is used for topical application to the surgical site of glaucoma filtration surgery; it is not intended for intraocular administration. The most common side effects with Mitosol occur locally and include low intraocular pressure (IOP), maculopathy, bleb infection, intraocular inflammation, vascular reactions, corneal reactions, and cataracts.