Patients can take measures to protect themselves against counterfeit medications, says Connie Jung from the Office of Drug Security, Integrity and Recall of the U.S. Food and Drug Administration. Speaking at the 2011 Partnership for Safe Medicines Interchange, she said that patients first of all need to be aware of the risk of receiving counterfeit…
Read MoreCooperation between the U.K.’s Medicines and Healthcare Products Regulatory Agency and the USFDA brought the counterfeit Avastin distribution to light in the U.S. when MHRA officials let U.S. Food and Drug Administration agents know in December that they suspected the problem.
MHRA officials notified U.S. agents and Roche, which led Roche to test and confirm the vital life-saving medication as counterfeit last week, reported Reuters.
“As tragic as this incident is, it is to the credit of the manufacturer and law enforcement that they’ve been able to track down the source of the supplier of the counterfeit medication and contact their other customers. In many countries counterfeits make their way to patients without anyone ever being held accountable,” said Partnership for Safe Medicine’s board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute.
Connie Jung, of the FDA’s Office of Drug Security, said it was possible that more than the 19 originally notified practices could be involved and warned that if a price appears to be too good to be true, it probably is.
Sources say that Montana Health Care Solutions sold the vials for 25% less than the expected cost, reports ABC World News.
Patients are beginning to be aware of the counterfeits, with growing outrage.
Said cancer patient Diane Barraza to ABC World News, “To sit in the chemo chair and watch that stuff drop into my veins,” who lives in Fullerton, Calif., with her 6-year-old daughter. “It’s all I’ve got. And it might just be water?”
The FDA has issued letters to 19 US medical practices that purchased medication from a foreign supplier, Quality Specialty Products (QSP), warning that drugs distributed by QSP are known to be unapproved by the FDA, and in at least one instance verified counterfeit.
QSP, also known as Montana Health Care Solutions, has been identified by the FDA as the distributor of counterfeit Avastin. Roche AG, the manufacturer, has said that the counterfeit Avastin was tested and found to contain no active ingredient. Avastin is FDA approved for use in metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer, metastatic kidney cancer, and glioblastoma.
Read MoreA counterfeit version of Avastin cancer therapy has been found in the U.S. announced manufacturer Roche Holding AG, a Swiss company.
Vials of the medication were tested by Roche and found to not contain the active ingredients, according to Roche’s Genentech unit, reported The Wall Street Journal.
This is a reprint of the FDA alert. Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The…
Read MoreClemsford Crown Court sentenced two men who pleaded guilty to advertising and selling prescription only medicines on websites. The two Essex residents, Steven Corbersmith, 35, from Frinton-on-Sea, and Stefa Hazell, 28, from Kirby-le-Soken. ran two websites that illegally sold prescription only medications clomiphene citrate, used for fertility enhancement, and anabolic steroids, reported the UK’s Medicines…
Read MoreOn January 19, 2012, AstraZeneca sent members of Congress a letter supporting legislation to increase penalties for counterfeit prescription drug crime.
The letters were sent to Senator Patrick Leahy (D-VT), Senator Chuck Grassley (R-IA), Representative Linda Sanchez (D-CA), and Representative Patrick Meehan (R-PA), bill sponsors along with Senator Michael Bennet (D-CO) and Senator Richard Blumenthal (D-CT.).
Read MoreThe most potent anti-malarial drug has been found in counterfeit version in 11 African countries. On top of not curing patients sick with deadly malaria, lower than therapeutic doses of the active ingredient artemisinin in the fake meds can cause the parasites to develop resistance to the medication. In essence, the counterfeit drugs are likely to cause a mutation in the parasite, creating a newer, deadlier version of malaria not able to be cured by any known medication.
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The Partnership for Safe Medicines released a video about the recent conviction of counterfeit drug seller Manuel Calvelo on youtube. The video, available here, is narrated by counterfeit medicine victim Rick Roberts, a patient advocate who has spoken about his experience receiving vital life-saving medicines that turned out to be fakes in front of Congress and at the Interchange.
Roberts explains the case of Manuel Calvelo, a Belgian citizen who ran numerous online fake pharmacies that sold so-called generic versions of non-generic drugs that claimed to treat serious health concerns, such as a heart disease, stroke and diabetes. Instead the medicines were tested and found to be fakes by FDA agents.
Read MoreOn the occasion of the silver jubilee of its enactment, the Consumer Protection Act of 1986 was commemorated in Kochi at a function organized on the 24th of December by the Partnership for Safe Medicines – India. Speaking on the occasion, Mr. K.V. Thomas, Union Minister of State for Consumer Affairs, Food and Public Distribution,…
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