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Alcohol pads recalled because of possible contamination by Bacillus cereus bacteria

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Several manufacturers, including Pfizer Inc. and Merck & Co., are warning users of certain injectable drugs not to use the disinfecting pads or swabs that came with the drugs, citing possible contamination. The alcohol prep pads and swabs, which are used to sterilize the epidermis prior to an injection, were recalled earlier this month by the supplier, Triad Group, due to concerns about potential contamination by an organism that can cause life- threatening infections.

Triad, of Hartland, said it had received a single report of a non-life-threatening skin infection "out of hundreds of millions of products sold." Since Triad's recall note, many drug makers have issued their own alerts about the recall. Pfizer and its partner Progenics Pharmaceuticals Inc. said 02/02/2011 they have suspended shipments of injectable formulations of anti-constipation drug Relistor until the Triad-supplied alcohol pads can be replaced. The companies said they would start shipments again as soon as possible.

Representative of Pfizer said the suspended shipments would have no critical economic impact, and that single vials of Relistor continue to be sold. GlaxoSmithKline PLC said some of the Triad pads may have been included in U.S. packaging for starter kits for the blood-thinning medication Arixtra. Roche Holding AG said Triad pads are distributed with several drugs including the Boniva bone-building remedy and hepatitis C treatment Pegasys. Bayer AG said the Triad pads are packed for use in the U.S. with multiple-sclerosis drug Betaseron.

“Triad pads were distributed with Pegintron, a treatment for hepatitis C, and a associated drug, Intron A, outside the U.S, Merck said. Also Merck confirmed that the drugs distributed in the U.S. aren't affected. Merck said it will start out packaging orders for the drugs without alcohol prep pads until an appropriate alternative has been identified. Furthermore, Health Canada said Teva Pharmaceutical Industries Ltd. is advising patients taking the Copaxone MS drug not to use any Triad pads.

The pharmaceutical companies said their medicines weren't contaminated, and that they can resume to be used as directed, except that any Triad pads or swabs should be discarded. Triad said in the beginning of 2011 the recalled products were distributed in the U.S., Canada and Europe. Some were made for third parties including drug distributor Cardinal Health Inc. and drugstore chains Walgreen Co. and CVS Caremark Corp. As alternatives, patients are advised to use pads or swabs supplied by other manufacturers, or use a gauze pad or cotton ball to administer 70% isopropyl alcohol to the injection site.

Instructions for how to return the recalled products are available by calling the Wisconsin-based company at 262-538-2900. More facts about the Triad recall might be found on the Food and Drug Administration's website.


FDA warns public of internet pharmacy extortion scam

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Criminals posing as law enforcement agents are scamming people who purchase drugs over the internet, the Food and Drug Administration is warning consumers Friday.

The international extortion scam targets people who bought drugs online or from telepharmacies. The victims are called by criminals posing as FDA special agents or other law enforcement personnel. They are told that buying drugs over the telephone or internet is illegal and threatened with police action unless fines ranging between $100 and $250,000 are paid.

The victims are asked to send the money by wire transfer to a specific location usually in the Dominican Republic. The FDA says if they refuse, they are threatened with property searches, arrest, physical harm, incarceration and in some cases deportation.

"Impersonating an FDA official is a violation of federal law," said Dara Corrigan, the FDA's associate commissioner for regulatory affairs. "FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action."

The extortionists have detailed personal information the agency says came from previous online purchases, including names, date of birth, addresses, phone numbers, social security numbers and credit card information. They are using telephone numbers that make it appear as thought the calls are coming from the United States, but the FDA believes most of the calls are coming from overseas. So far none of the victims has been approached in person.

Currently the FDA, along with the U.S. Drug Enforcement Administration (DEA), and the U.S. Immigrations and Customs Enforcement, Homeland Security Investigations and various U.S. Attorneys are pursuing several criminal investigations on both the national and international level.

There are already been some arrests and prosecutions are pending, but the FDA's warning to consumers is "the scheme is likely to continue." They say victims of these scams should contact the FDA's Office of Criminal Investigations.

The agency has issued a number of these warnings in the past and in Friday's statement to consumers, remind consumers that it's buyer beware. "Pharmaceutical products offered online and by telephone by sources of unknown origin can pose a substantial health risk. Products recovered during this investigation that were purchased from online or telephone sources have been found to contain trace amounts of heroin, other undisclosed and potentially harmful active pharmaceutical ingredients, or no active ingredient at all. Purchases should only be made from licensed pharmacies located in the United States. In addition to the increased risk of purchasing unsafe and ineffective drugs from websites operating outside the law, personal data may be compromised."


Canada will not be associated with the global center of pharmaceutical spam anymore

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Billions of email users around the planet may not be able to criticize Canada anymore for most of the annoying spam in their inboxes. For a long time, Canadians have been unfairly maligned as some of the world's worst peddlers of spam, theoretically responsible for flooding accounts with typo-ridden sales pitches for low-cost erectile dysfunction tablets. In 2010, on an average 300 billion spam messages were being sent everyday, and estimates suggest around 85% were often linked to some kind of pharmaceutical drug scam, mostly from an online «company» called Canadian Pharmacy.

The Canadian International Pharmacy Association, the organization that represents legitimate online pharmacies in Canada, gets regular calls and emails asking whether certain companies are above board. Spammers have capitalized on the price disparity between prescription drugs in Canada and the United States in a bid to catch the attention of American email users. They send a staggering number of emails and wish to fool just a small part of the recipients into thinking they're dealing with a trustworthy operation.

We hear about that type of situation and we know it exists said spokesman Tim Smith. It's a concern for us when we see activity like this. We have definitely seen a grow in inquiries from people looking for legal companies, mostly American customers who are plagued by the outrageous cost of medication and healthcare in the United States and are out searching he said. Tom also notes he's also heard from victims who have lost money to spammers. Virtual outfits like Canadian Top Pharmacy, Montreal Drug Store, Canadian Pharmaceutical Mall, Canadian Quality Prescription Drugs and Best Canadian HealthCare Pharmacy have made big business out of fraudulent drug offers, but changes at the top levels of the spam world suggest Canada is starting to get left out of pharma scams.

This also a big concern for a largest maker of security software for computers, headquartered in Mountain View, California "Symantec". In the last three years, "Canadian Pharmacy" has certainly been the largest and most productive pharmaceutical spam brand in the wild states a report by the security researchers at MessageLabs Intelligence, which is owned by online security laboratory Symantec.

Suddenly all that changed in the end of the last year. In October, one of the world's most prolific spammers, an organization called Spamit, ceased operations, and analysts immediately noticed a enormous drop in overall spam traffic. Russian authorities have estimated the outfit had collected $120 million over the past 3 and a half years in connection with its spam before it shut down. Then in December, another large organization, Rustock, stopped sending out spam for a two-week period, without explanation.

Rustock had been responsible for almost half of the spam regularly sent out, MessageLabs estimates. The company has since resumed spamming but its output is nowhere near as high as it once was and its tactics seem to have changed. The spammers spamming on behalf of this particular 'Canadian Pharmacy' brand have moved to ... other brands, the templates are somewhat different now and the web site pattern has also shifted as well, said Paul Wood, a spokesman for Symantec. It suggests an instability has taken place in the pharmaceutical sector of the spam community. Email scams that used pharmaceutical drugs as a lure had dropped from the 80% range of all spam to almost 64.2% at the end of 2010, and in January dropped again to about 59%, according to MessageLabs. While there are still a few major scam sites using Canada as fragment of their names, spammers appear to be trying more generic names like HealthRefill, Medsleader, MedrugsPlus, Internet Drugs Pedia and Men Drugs Shop, says the MessageLabs report.

It's very likely that most email users haven't noticed much of a difference in their inboxes, even though changes in the spam business have been impressive in the last few months. That is because pharma spam has long been targeted by IT professionals, Stern said. With pharmaceutical spam, because it was so voluminous, it was priority one for us and all the other spam vendors, because if you let one through then you've let through 10,000 in the next second, he said. Stern said, the amount of spam in inboxes will remain about the same but organizations will see reduced IT costs because of less spam to contend with. Stern and his colleagues have been following Canadian pharmacy scams for some time and in 2008 conducted an investigation to see what would come off if they actually responded to a spam letter offering Viagra. They sent a staffer to visit a Toronto address given as the company's headquarters, which turned out to be a Subway sandwich store in a strip mall.

Surprisingly, a parcel did eventually arrive in the post its postage indicated it came from Mumbai and inside a battered envelope was a plastic bag containing a few blue pills. A toxicology report revealed they were not genuine Viagra. A second order placed through another email resulted in a package arriving from Shanghai, with a number of pills taped inside a magazine.

They also were not real Viagra pills but did contain the active ingredient - sildenafil in the drug. Stern said that even with the dramatic decrease in spam levels and the changes with the major players, other groups will definitely emerge and the battle to contain spam will continue. Spammers will go through (websites) every few minutes, so it takes a lot more energy to take them down than to put them up.


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