FDA Evaluating Cancer Link in Parkinson’s Drug

The U.S. Food and Drug Administration is evaluating clinical data that may suggest Novartis AG’s Parkinson’s disease treatment Stalevo is linked to an increased risk of prostate cancer.

Data from a long-term clinical trial, known as STRIDE-PD, unexpectedly found that a greater number of patients taking Stalevo had prostate cancer compared to those taking another Parkinson’s treatment, the FDA said.

The agency said it has not concluded that Stalevo increases the risk of developing prostate cancer, and advised patients not to stop treatment unless told to do so by their doctors.

“The agency is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer,” the FDA said in a safety communication posted on its website on Wednesday.

Novartis did not have an immediate comment.

Stalevo — which contains the active ingredients carbidopa, levodopa and entacapone — is marketed in the United States by Swiss-based Novartis and manufactured by Finnish drugmaker Orion.

Novartis reported global sales last year of $554 million for Stalevo and another Parkinson’s drug, Comtan, which contains entacapone.

Novartis shares rose 1 percent to $54.19 on the New York Stock Exchange late Wednesday afternoon. Fox News

River Blindness

river blindness_A clinical trial to introduce a new drug to eliminate river blindness has been launched by the World Health Organisation (WHO) in three African countries. The drug is called Moxidectine, which is being investigated for its potential to kill or sterilise adult worms of Onchocerca volvulus, which causes river blindness. The drug has a potential to interrupt the disease transmission cycle within around six annual rounds of treatment. The drug is a veterinary marcocyclic lactone drug.

A press release signed by Jamie Guth, Communication manager for Training in Tropical Diseases,stated that the trial, which started in April 2007, would run for two-and-a-half years in Ghana, Liberia and the Democratic Republic of Congo.

Each country would be provided with the necessary equipment and research teams trained on how to conduct the trial according to international standards and in Ghana, the trial would be conducted in the Volta Region.

The objective of the Africa Programme for Onchocereciasis Control was to establish, within a period of 12 to 15 years, an effective, self-sustainable and community directed treatment with invermectine throughout the endemic areas within the geographic scope of the programme, develop the evidence base and assist countries to determine when and where Ivermectine treatment can be stopped.

“The moxidectine data have been promising so far, and as the programme moves into a larger phase we are hopeful that moxidectine will constitute a significant advance against the devastating disease,” the release said.

The studies were aimed at providing data on moxidectine in subjects infected with Onchocerca Volvulus for determination of safety, tolerability and efficacy. The exact mechanism of action of Moxidectine is still under investigation.

The statement said the disease had been controlled by invermectine, which was donated by a Pharmaceutical company to river blindness endemic countries. River blindness is an eye and skin disease caused by the parasitic worm, Onchocerca Volvulus, which is transmitted from person-to-person through the bite of black flies of the genus simulium. The disease is the world’s second leading infection cause of blindness.

Physicians Can Make A Lot Of Difference

drugs_You know, there’s a lot of good evidence for people who are early in having problems with drugs or alcohol, a few minutes with a physician can make a lot of difference. Well, would you really know if your teen was experimenting with drugs? Many parents don’t have a clue, but even if they are not using, you will be armed with the knowledge and ability to better detect if something is wrong. If you’re like most parents that have gone through this, when finding out their teen was experimenting, or addicted to drugs, it hit them like being slapped because no parent wants to believe that their kid is experimenting with, or addicted to drugs.

And making matters worse, they were unprepared for the aftermath, often leaving them numb, in disbelief, and ready to accept any explanation their teens might conjure up denying he/she is using. And so before anything else may get worse, why not refer and put them into a drug rehab treatment program, the best known place to be for people having more serious problems. One of the most popular excuses teens give when caught with drugs is: “it’s not mine. I was holding it for someone else.” If you buy this, please slap yourself in the face to wake up because you’re unconscious. After all, it’s not the drug dealers you need to be worrying about; it is friends, relatives, and the medicine cabinet in your own home.

‘A Risk To Child Health’

ebay_medicinesA pediatrician is warning that “net literate” parents are putting their children at risk by buying drugs on the web. Dr Nadeem Afzal, a consultant pediatric gastroenterologist, carried out an investigation of medicines for sale on eBay for common gut complaints such as constipation, diarrhea, colic and abdominal pain. He found that 53% of the 186 gastrointestinal drugs on offer were advertised for children. One of these, Infacol for colic, was being sold with a broken seal and the description “slightly used”.

Other sellers did not list side-effects or provide use-by dates, and some suggested double the dosage that would normally be given in the UK. His findings have concerned the Royal Pharmaceutical Society of Great Britain, the Association of the British Pharmaceutical Industry and the British Medical Association. Afzal said he was particularly worried that 42% of sellers gave no contact or address information so purchasers would have no legal recourse in the event of a problem. Other “dangerous practices” included laxatives being described as slimming pills and as treatments for diarrhoea.

Afzal, a consultant at Southampton General hospital, presented his findings to the Royal College of Pediatrics and Child Health spring meeting to raise awareness and is now calling on eBay to place better guidance on the site. The drugs on offer over a period of a month were mainly over-the-counter remedies, but did include some antacid treatments that are prescription-only for the under-16s. One seller’s listing said it was suitable for over-12s.

ABPI spokesman Crispin Slee said: “Anyone who buys prescription drugs over the internet is taking a huge risk. It is worrying enough to think that adults are self-prescribing in this way. But to learn that parents are putting their children in harm’s way beggars belief. Parents from the Google generation are playing russian roulette with their children’s wellbeing.”

In the study, 42% of sellers did not mention dosages, 93% ignored side-effects and 14% didn’t list what the drug was suitable for. Almost a third of sellers were offering drugs alongside household goods such as gardening tools, cosmetics and toys. “I suspect net literate people are tempted to buy online to save money and for convenience’s sake,” Afzal said. “This is not about the blame game, this is about awareness.”

He added: “The onus is on the lister, not on eBay. That should change. They should state online: ‘Check the MHRA [Medicines and Healthcare products Regulatory Agency] guidance on the sale of medicines.’ Also, people need to be made aware that just because a seller has got a 99% positive feedback rating, it does not mean that this [product] is not counterfeit.”

The Royal Pharmaceutical Society estimates that two million people buy drugs regularly over the internet, many from legitimate online pharmacies. But other sellers are offering counterfeit or substandard drugs. In April, GP magazine reported that one in four family doctors has treated patients for adverse reactions to medicines bought online.

David Pruce, director of policy and communications at the Royal Pharmaceutical Society, said: “It’s horrendous that people would even consider buying medicines with broken seals or from unknown sources. You should never take a prescription medicine without a valid prescription, let alone give these to your children. The medicine could have bad side-effects or worse.” A spokesperson for eBay said: “We strongly encourage our users to be entirely accurate in their listings and to ensure that the packaging is intact. We are now looking at new ways of strengthening safeguards in this area.”