‘Needle risk’ over beauty treatments.


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A health watchdog is concerned that people having beauty treatments like Botox could be at risk of infection from dirty needles.

The National Institute for Health and Care Excellence says growing numbers of people are injecting tanning agents, dermal fillers and Botox at home and in salons, and some are lax about hygiene.

Sharing needles can spread blood-borne diseases like HIV and hepatitis C.

Nice is updating its advice for England and Wales accordingly.

The guidelines, which are out for public consultation, aim to encourage people to use sterile needle and syringe programmes to stem the spread of infections.

Sharps bins

Most blood-borne diseases occur among people who inject drugs like heroin and anabolic steroids.

But NICE says people seeking out cosmetic fixes are also at risk.

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The dangers of sharing needles in cosmetic injectables are so great that any practitioner who does this should be considered guilty of a criminal offence and nothing less”

President of BAAPS Rajiv Grover

A spokeswoman said: “We are seeing an increasing issue with drugs that are used for vanity purposes.”

This includes the anti-wrinkle treatment Botox, dermal fillers and tanning agents.

Prof Mike Kelly, Director of the NICE Centre for Public Health Excellence, said: “Since we last published our guidance on needle and syringe programmes in 2009, we’ve seen an increase in the use of performance-and-image-enhancing drugs such as anabolic steroids, Botox, tanning agents and the use of dermal fillers like collagen.

“We’ve also heard anecdotal evidence that more teenagers are injecting these performance-and-image-enhancing drugs too.

“We’re updating our guidance – and our public consultation on the draft update is an important part of this process – to make sure all of these groups of people are considered in the planning and delivery of needle and syringe programmes.”

One of the recommendations proposed in the new guidelines is that local councils consider providing sharps boxes for people to dispose of used needles and syringes.

Rajiv Grover, consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said: “Due to the lack of regulation in the cosmetic sector it is impossible to know how many patients could be at risk of blood borne diseases from needle sharing with either Botox or fillers.

“These should be considered medical procedures and BAAPS has campaigned for over a decade to have this field of non-surgical cosmetic treatments tightly regulated. The dangers of sharing needles in cosmetic injectables are so great that any practitioner who does this should be considered guilty of a criminal offence and nothing less.”

Allergan, a healthcare company that provides Botox, said that Botox is a prescription-only medicine which should only be administered by a trained and qualified medical healthcare professional.

“These treatments should be carried out by appropriately trained and qualified medical practitioners, who have high levels of expertise in full-face anatomy and can provide sufficient aftercare and redress for the patient in the event of an adverse event,” said a spokesman.

FDA denies approval to Endo’s testosterone drug again


The Food and Drug Administration has for the third time refused approval to Endo Health Solutions Inc’s injectable testosterone drug Aveed, pressing for a still better plan to manage the risks associated with the drug.

The denial comes as no surprise after an advisory panel to the FDA overwhelmingly agreed in April that Endo’s proposed plan for managing the risks associated with the drug was insufficient.

Testosterone, a hormone produced in the testicles, is responsible for maintaining muscle bulk, bone growth and sexual function. Lack of testosterone can lead to loss of libido, depression, decreased muscle mass and fatigue.

Aveed is made of testosterone and castor oil and the FDA has previously expressed concern of a risk that the oil could cause blockages in blood vessels in the lungs.

Lack of a suitable strategy to address these issues had led the FDA to refuse Aveed’s marketing application the last two times.

On Thursday, Endo said the agency wants it to include a medication guide and other some additional elements to its risk mitigation strategy to ensure the safe use of the drug and to avoid severe complications related to post-injection reactions, the drugmaker said on Thursday.

It, however, did not ask Endo to perform an additional clinical study.

Endo added that it plans to respond to the FDA by the end of the third quarter of this year.

Endo’s shares closed at $35.94 on Thursday on the Nasdaq and declined only marginally to $35.91 after market close.

 

Source: yahoo news