PHARMACY

FDA issues warning about fraudulent Tamiflu

BY Allison Cerra

ROCKVILLE, Md. The Food and Drug Administration issued a consumer warning Thursday about a potentially harmful product represented as “generic Tamiflu” sold over the Internet.

FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin, the government agency said.

Although the FDA bought the fraudulent “generic Tamiflu” without a prescription from a website claiming to be an online drug store that is no longer operational, the fraudulent version likely is to be found for sale on other websites.

“A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation,” said FDA commissioner Margaret Hamburg. “Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder. The foil backing is printed, and labeled in part, “Oseltamivir phosphate 75mg. capsules TM-FLU capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

 

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FDA approves Jevtana

BY Alaric DeArment

SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for advanced prostate cancer, the agency said Thursday.

The FDA announced the approval of Sanofi-Aventis’ Jevtana (cabazitaxel), a chemotherapy drug used with the steroid prednisone. The agency said the drug was the first treatment for advanced, hormone-refractory prostate cancer that has worsened during or after treatment with docetaxel, also a chemotherapy drug used in advanced prostate cancer. Hormone refractory prostate cancer happens when prostate tumors continue to grow despite treatments meant to reduce the body’s production of the male hormone testosterone, which helps prostate tumors grow.

“Patients have few therapeutic options in this disease setting,” FDA Center for Drug Evaluation and Research Office of Oncology Products director Richard Pazdur said. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”

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Report: Oregon State Board of Pharmacy declares marijuana as drug with medical use

BY Alaric DeArment

SALEM, Ore. The makers of the 1930s documentary “Reefer Madness” would be furious at the news, but it likely will come as a relief to people with certain diseases and marijuana law-reform advocates.

The Oregon State Board of Pharmacy voted Wednesday to have marijuana classified as a drug with medical use, according to reports from a local TV station. The decision makes the state to reclassify it as such.

Under the decision, marijuana will be known as a Schedule II controlled substance, meaning that it has high potential for abuse but still has medical benefits. Previously — and still in all other states — marijuana was a Schedule I drug, meaning it had no medical benefits.

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