FDA Receives Reports of Fatalities Associated With Undeclared Ingredients

The U.S. Food and Drug Administration has issued an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared prescription drug ingredients that have impacted public safety.

The agency announced it has received reports of “fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome,” in the two months since initially announcing the recall on the product in June.

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As US Citizens Bring Resistant Malaria Strains Home, A Third of All Malaria Drugs Tested are Fake

Malaria is a major concern for public health officials throughout much of the world. Now a new report indicate US citizens returning from Africa are coming home with drug-resistant malaria, while The Lancet tells us up to one third of all malaria treatments are counterfeit.

News from Alertnet reports that US travelers returning from visits to sub-Saharan Africa are bringing home artemisinin-resistant malaria. Though no indication of large-scale malaria drug resistance has yet appeared on the African continent, it is a worrying trend that may presage full-scale drug resistance in African malarial strains.

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USAID: Fighting Counterfeit Malaria Drugs Worldwide

Drug resistance as a result of the proliferation of counterfeit/low dose treatments is a growing problem in the fight against malaria. USAID is leading the charge to combat counterfeit malaria treatments in the places where malaria drug resistance is developing.

Drug counterfeiters, exploiting a captive audience in malaria sufferers, have helped create artemisinin-resistant malaria strains along the Thai/Cambodia and Thai/Myanmar borders. Counterfeit versions of malaria drugs have proliferated along the war-torn borders in Southeast Asia, and are also showing up in several African nations.

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Overseas Counterfeit Drug Supplier Pleads Guilty to Federal Charges

Robin Han, a citizen of New Zealand, faces up to 30 years in prison and possible $6 million fine after pleading guilty to counterfeit drug charges last month.

US attorneys from the Central District of California have successfully prosecuted Han on charges he was a large scale trafficker of counterfeit drugs in the United States. His indictment was originally filed in 2007, but he was a fugitive from justice until March 29th of this year, when he was taken into custody at San Francisco International airport, reports U.S. Immigration and Customs Enforcement.

Han became a target of the federal probe in 2006, after US Customs and Border Protection officers intercepted a parcel containing counterfeit versions of erectile dysfunction medication. Subsequent investigation traced the shipment to Robin Han.

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Chinese Government Detains Close to 2,000 on Counterfeit Drug Charges

Chinese officials announced the arrest of almost 2,000 people in a counterfeit drug ring operating in China. Authorities there said the drugs discovered were responsible for causing serious ailments, such as liver & kidney damage, and heart failure.

According the Reuters, suspects in the case were advertising the sale of their drugs online, in newspapers, and even on television.  More than 1,000 manufacturing facilities for counterfeit medicines were destroyed, and more than $180 million worth of counterfeit drugs.  

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McCoy D, Pitsillidis A, Jordan G, et al. PharmaLeaks: understanding the business of online pharmaceutical affiliate programs. In: Security’12 Proceedings of the 21st USENIX conference on Security symposium. Pages 1-1; USENIX Assn Berkeley, CA 2012.

Abstract: Online sales of counterfeit or unauthorized products drive a robust underground advertising industry that includes email spam, "black hat" search engine optimization, forum abuse and so on. Virtually everyone has encountered enticements to purchase drugs, prescription-free, from an online "Canadian Pharmacy." However, even though such sites are clearly economically motivated, the shape of the underlying…

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FDA Commissioner Margaret Hamburg Keynote Speaker at 2012 Interchange

Just announced! Dr. Margaret Hamburg, FDA Commissioner will be the keynote speaker at the 2012 Interchange, September 28th in Washington DC!

We’ve just received official confirmation that Margaret Hamburg, Commissioner of the United States Food and Drug Administration, will give the keynote speech at the  2012 Partnership for Safe Medicines Interchange. We’re very honored to have Commissioner Hamburg speak at the Interchange, and look forward to hearing her offer her expertise on the subject of counterfeit drug crime.

Dr. Hamburg is the 21st commissioner of the Food and Drug Administration. She was confirmed in her post on May 18, 2009. She is only the second woman to be nominated for this position, having served previously as an Assistant Secretary at the US Department of Health and Human Services, and also as Commissioner of the New York City Department of Health.

Fake online drug sellers, gray market distributors, and counterfeit medicines in the U.S.’s safe, secure drug supply chain will be subjects discussed at the 2012 Interchange in Washington DC September 28th. Please join us!

This will be the second time Commissioner Hamburg has spoken at a Partnership for Safe Medicines Interchange. She first joined us in 2010, where she addressed the problem of counterfeit drugs, “The issue of counterfeit drugs is one of both domestic and international concern. It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit.”

Since her appearance at the 2010 Interchange, the FDA has had to contend with an increasingly globalized drug marketplace. Her continued efforts as commissioner have been to seek greater penalties for drug counterfeiters, and also give the FDA more authority to deal with counterfeit drugs when they discover them.

We hope you will join Commissioner Hamburg, Deputy Director Heddell of the MHRA, Associate Director Dinkins of the ICE Homeland Security Investigations, along with many other experts from medicine, policy, law enforcement, and patient advocacy at our 2012 Interchange in Washington DC. Discounted early registration ends August 15th, so register today!

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Arrest Warrant Issued for Convicted Canadian Online Pharmacy Operator

An arrest warrant has been issued by Judge Irma Gonzalez, in the U.S. District Court for the Southern District of California, in San Diego, for Canadian businessman Nathan Jacobson as a result of his failure to appear for sentencing in the vast Affpower fake online pharmacy case.

In 2007, Jacobson was one of 18 indicted on racketeering and related charges for allegedly operating an internet business that generated more than $126 million in gross revenues from the illegal sale of prescription medicines from customers across the U.S., reported the U.S. Department of Justice.  

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