The European Medicines Agency (EMA) has recommended label changes to Servier’s osteoporosis drugs Protelos and Osseor to include new contraindications and revised warnings.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the drugs are an important treatment for women with osteoporosis, but that the associated risks need better management.

The CHMP no longer recommends Protelos and Osseor (strontium ranelate) for use in immobilised patients or patients with venous thromboembolism (VTE), and has recommended an update of the warnings regarding serious skin reactions.

Both drugs are indicated for the treatment of osteoporosis in postmenopausal women to reduce the risk of hip and spine fractures.

The review followed the publication of a French study that identified 199 severe adverse reactions to these medicines between January 2006 and March 2009. Around half were VTE events and around a quarter were skin reactions.

The risk of VTE was identified in clinical trials, and the risk of severe skin reactions had been reported from patient experience. These risks were already noted in the product information.

The CHMP has reviewed all available data on the safety of Protelos and Osseor and recommended:

• Doctors should not prescribe these drugs for patients with VTE or a history of VTE, or to patients who are immobilised. Patients in these categories should discuss their treatment with their doctor at their next scheduled appointment.

• Doctors should re-evaluate the need to continue treatment with Protelos or Osseor in patients over 80 years of age at risk of VTE.

• Prescribers should make patients aware of the time-to-onset and likely signs and symptoms of severe skin reactions. Patients should stop treatment immediately if such symptoms occur, and not resume at any time.

Draft NICE guidance does not recommend the routine use of AstraZeneca’s anti-oestrogen drug Faslodex (fulvestrant) in the NHS to treat certain types of breast cancer.

Faslodex was authorised in 2010 for marketing as an alternative to aromatase inhibitors to delay the growth of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who have already received anti-oestrogen therapy (such as tamoxifen).

NICE’s Independent Advisory Committee has concluded that the drug is not significantly more effective than existing treatments, and so its routine use would not be a good use of resources.

The Committee judged AstraZeneca’s claim that Faslodex could extend life relative to the aromatase inhibitors anastrozole and letrozole to be uncertain as network meta-analyses showed no statistically significant differences.

In addition, they found that Faslodex delayed cancer growth more effectively than anastrozole but not more so than letrozole. An incremental cost effectiveness ratio of £35,000 per QALY gained for Faslodex 500mg compared with anastrozole was estimated, but with “considerable uncertainty”.

The draft guidance thus recommends that NHS doctors should not prescribe Faslodex as an alternative to aromatase inhibitors in relevant cases – but that women who are currently receiving Faslodex should be able to continue to do so until they and their doctors decide to stop.

Sir Andrew Dillon, Chief Executive of NICE, commented: “While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.

“As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use.”

The draft guidance is open to appeal until 24 November. NICE hopes to publish final guidance in January 2012.

NICE has not recommended Faslodex (fulvestrant) for women with locally advanced or metastatic breast cancer after its Appraisal Committee declared it was not a good use of NHS resources.

The Committee raised questions over the data supplied by AstraZeneca on the treatment’s efficacy and its cost effectiveness.

Sir Andrew Dillon says the Committee “had not been given any conclusive evidence” that Faslodex extends life or delays tumour progression when compared with current treatment options.

Faslodex was being appraised as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer, that is oestrogen-receptor-positive.

It is licensed for postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

In line with its European marketing application, the decision by NICE’s independent panel of experts relates to the use of the inhibitor once anti-oestrogen treatments are no longer controlling the spread of the tumour.

But during the appraisal it was not able to consider the clinical and cost effectiveness of the treatment when used outside of its marketing authorisation.

“After analysing the evidence comparing fulvestrant’s clinical effectiveness with aromatase inhibitor therapy, our independent committee found that the estimates of overall survival and time to tumour progression were very uncertain,” said Sir Andrew Dillon.

“While it is important for women with locally advanced or metastatic breast cancer to have a range of options, NICE has to ensure that the NHS provides treatments that bring benefits which are value for money.”

NICE’s decision is now open to public decision. The Institute expects to publish final guidance in January 2012.