Articles from June 2010

Counterfeit dapoxetine sold on the Internet contains undisclosed sildenafil

A recent article in The International Journal of Clinical Practice assess the identity, amount of active pharmaceutical ingredients and the impurity profile of counterfeit Priligy® (a medicine for premature ejaculation) found on an ‘online pharmacy’. The medicine was analysed using the same methods as in the quality control for genuine Priligy®, and was found to contain additional ingredients to those specified on the product packaging and internet site. As well as containing the specified active ingredient dapoxetine, the tablets also contained 5.6mg (13%) of sildenafil (the active ingredient used in the treatment of erectile dysfunction) despite no disclosure on product packaging or the internet site. Consequently, this poses an undisclosed risk to potential customers in which sildenafuil may be contra-indicated, highlighting the inherent dangers of counterfeit medicines and purchasing medication online.

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MHRA investigation leads to 6 month prison sentence for sale and supply of fake slimming pills

David Green of Wickersley, Rotherham, pleaded guilty for the illegal sale and supply of unlicensed slimming pills, as well as possession of another medicine with which he had the intention of selling on his website, as well as via online auction sites, without a license.

MHRA investigators seized several hundred bottles of the slimming pills from Mr Green which laboratory results later confirmed contained ephedrine.

MHRA Head of Operations, Danny Lee-Frost, said: « This is yet another example of the danger of buying any type of drug from an unregulated source. You simply don’t know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health. »

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Counterfeit drugs can be identified in seconds with new technology from Gilden Photonics

Glasgow based Gilden Photonics have devised a revolutionary system using spectroscopic technology which can identify fake drugs from suspect batches in seconds, without even opening the packet.

The portable devises deploy a beam of light to detect counterfeits by comparing the spectral signature of the fakes with the real drugs.

Kevin Lynch of Gilden Photonics explains the concept: « When the laser beam passes through we check the reflection from the drug in the spectral graph. As we have a database which shows what the real drug should look like we can tell whether the substance is the real deal or not in no time at all. »

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Can combating the counterfeits hurt Pharma too?

A PharmExec article that looks at the effects of fighting against counterfeits on big brand name manufacturers.

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MHRA seizes £150,000 worth of fake drugs across London and Yorkshire

With the assistance of local police and information initially passed to the MHRA by pharmaceutical manufacturers Pfizer, Lilly and Sanofi-aventis, counterfeit and controlled drugs to the value of £150,000 were seized by the MHRA in 6 raids across London and 2 raids in Yorkshire. Six people in the UK believed to be linked to a gang in Asia were arrested in connection.

MHRA Head of Intelligence Nimo Ahmed said, « The products seized relate to treatment for depression, erectile dysfunction, as well as painkillers, sedatives and injectable anabolic steroids….Those involved in this type of criminality do not care about your health. They are only in it for one reason, and that is to make money’

Mr Ahmed took the opportunity to remind the public, ‘the safest way to obtain Prescription Only Medicines is from a ‘bricks and mortar’ pharmacy following a consultation with a GP or a healthcare professional. »

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Fraudulent Tamiflu found for sale on internet

The U.S. Food and Drug Administration have alerted consumers to the presence of fraudulent ‘generic Tamiflu’ available online after purchasing the counterfeit without a prescription from a website claiming to be an online drugstore that is no longer operational. The FDA warn however that the fraudulent version is likely to be found for sale on other websites and can be very dangerous to people allergic to Penicillin, following FDA tests revealing that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

Patients who are allergic to or may have experienced adverse reactions from penicillin products are at risk of experiencing similar reactions from cloxacillin, including anaphylaxis – a sudden, potentially life-threatening reaction with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D. said, « A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation…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. »

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