Latest Guidelines and Alerts from NICE and the MHRA

Peter Russell

October 12, 2018

A full range of non-surgical options should be offered to women with urinary stress incontinence and pelvic organ prolapse before treatment with surgical mesh and tape was offered as a treatment option, the National Institute for Health and Care Excellence (NICE) announced this week.

Alerts and warnings from the Medicines and Healthcare products Regulatory Agency (MHRA) urged doctors to reduce the risks of accidental harm and death associated with the misuse of transdermal fentanyl patches.

Mesh for Incontinence

New draft guidance on urinary stress incontinence and pelvic organ prolapse in women said surgical mesh and surgical tape should only be used as a treatment of last resort.

In July the Government issued a national 'pause' in England on the use of vaginal mesh implants following preliminary recommendations from an independent review which heard that thousands of women had experienced disabling conditions as a result of the treatment.

Women should be offered a full range of non-surgical treatment before the use of surgical procedures including mesh or tape, NICE said.

It also recommended a national database to be set up to record all procedures.

An investigative report in The BMJ this week said mesh manufacturers had "hustled" their products into widespread use, while an editorial in the same journal described the era of mesh implants as "shameful".

Burosumab for Treating Rickets

Burosumab (Crysvita, Kyowa Kirin) for treating X-linked hypophosphatemia (XLH) met with approval for routine NHS use in England and Wales.

Final guidance said that clinical trial evidence suggested that the monoclonal antibody provided short-term clinical benefits in children aged between 1 and 12 years and might provide lifetime benefits by preventing irreversible bone damage.

Burosumab is intended to increase phosphate reabsorption in the kidney and increase the production of vitamin D.

Chronic Wounds Dressings

The NICE medical technologies advisory committee (MTAC) has made draft recommendations on UrgoStart dressings for the treatment of chronic wounds, such as leg ulcers, pressure ulcers or diabetic foot ulcers, as well as for non-healing acute wounds.

The dressings contain a layer of open weave polyester mesh, impregnated with hydrocolloid polymers, within a petroleum jelly.

A consultation period will end on November 8th, 2018.

Padeliporfin for Prostate Cancer

A final appraisal has been drawn up on padeliporfin (Tookad, Steba Biotech) for treating localised prostate cancer.

The current recommendation was that padeliporfin – a light sensitive drug administered intravenously to kill cancer cells – should not be recommended for untreated, unilateral, low-risk prostate cancer in adults.

There was no clinical evidence on how effective padeliporfin was at slowing the disease, or extending life, compared with radical therapies, NICE said.

An appeal period for this appraisal will close at 5pm, October 26th, 2018.

MHRA Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a number of alerts this week.

These were:

Transdermal fentanyl patches: Doctors have been urged to give clear information to patients and caregivers about how to minimise the risk of accidental exposure to transdermal fentanyl patches.

The MHRA said it continued to receive reports of opioid toxicity after accidental exposure to patches, including five deaths in the last 4 years. It said fentanyl was a potent opioid analgesic, with a 25 µg per hour fentanyl patch equating to daily doses of oral morphine of up to 90 mg.

Patients should be reminded to follow instructions, recognise overdose symptoms, and store and dispose of the patches safely, it urged.

Rivaroxaban: A warning that oral anticoagulant rivaroxaban (Xarelto, Bayer) after transcatheter aortic valve replacement (TAVR) may increase all-cause mortality, thromboembolic, and bleeding events.

A preliminary analysis of a phase 3 clinical trial showed the risk of all-cause death and bleeding post-TAVR were approximately doubled in patients assigned to a rivaroxaban-based anticoagulation strategy compared with those given an antiplatelet-based strategy (clopidogrel and aspirin), the MHRA said.

Clinicians have been advised to discontinue treatment and switch to standard care.

Ponatinib: Doctors were advised to interrupt treatment with the tyrosine kinase inhibitor ponatinib (Iclusig, Incyte Biosciences) if posterior reversible encephalopathy syndrome (PRES) in patients receiving the drug. This follows reports of cases on post-marketing review.

The risk is thought to be up to 1 in 100 people taking the medicine.

Treatment should be continued only once the event is resolved and the benefit of continued treatment outweighs the risk, the MHRA said.

Ritonavir-containing products: Clinicians should monitor thyroid-stimulating hormone (TSH) monitor thyroid-stimulating hormone (TSH) in patients taking the anti-retroviral medication ritonavir (Norvir,AbbVie) being concurrently treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.

The MHRA said that reduced thyroxine levels have been reported in patients concomitantly taking ritonavir-containing products and levothyroxine.


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