Removal Of Black Triangle Status For Crestor, UK

Main Category: Statins
Also Included In: Cholesterol;  Cardiovascular / Cardiology
Article Date: 22 Jun 2007 - 1:00 PDT

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Following a comprehensive analysis of the pre and post marketing data by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) the risk/benefit profile for rosuvastatin (CRESTOR) has been confirmed and black triangle status has been removed for rosuvastatin.

What Does This Mean For Health Care Professionals?

New medicines are marked with an inverted black triangle symbol to encourage the medicine to be intensively monitored in order to confirm its pre- marketing risk/benefit profile in real life. The CHM and the MHRA therefore encourage health care professionals to report all suspected reactions to black triangle medicines through the yellow-card scheme. When the CHM and MHRA are satisfied that the benefit/risk profile for the medicine established during the pre-marketing phase has been confirmed, the black triangle status is removed and Healthcare Professionals are no longer required to report suspected non-serious adverse drug reactions through the yellow card system1. Therefore:

Rosuvastatin no longer has black triangle status because the benefit/risk profile has been confirmed by the MHRA and CHM. Health Care Professionals ( HCPs) are no longer required to report suspected non-serious rosuvastatin adverse events through the yellow card system.

In line with other established medicines, HCPs are now only required to report suspected serious adverse drug reactions* (and are no longer required to report non-serious adverse drug reactions) through the yellow card system.

AstraZeneca is committed to ensuring optimum patient care and proactively monitors the experience and use for all of its medicines on an ongoing basis.

* Definition of serious adverse drug reaction1: Serious reactions include those that are:

-- fatal;
-- life-threatening;
-- disabling or incapacitating;
-- result in or prolong hospitalisation;
-- congenital abnormalities; or
-- medically significant.

Rosuvastatin (CRESTOR®) 5-40mg

-- Rosuvastatin is available in 5mg-40mg dose range. The recommended start dose of rosuvastatin is 5 or 10mg2

-- The majority of patients achieve their LDL-cholesterol goal with rosuvastatin 10mg3-4

-- If necessary, dose adjustment to rosuvastatin 20mg can be made. Patients with severe hypercholesterolemia and at high cardiovascular risk who do not achieve their LDL-cholesterol goal with rosuvastatin 20mg may be titrated to the maximum dose of rosuvastatin 40mg2

-- Specialist supervision is recommended when the 40mg dose is initiated2

-- Rosuvastatin 20mg is the maximum dose to be used with concomitant fibrate usage; in patients with predisposing factors for developing myopathy/rhabdomyolysis; and in patients of Asian origin2

-- The 40 mg dose is the highest registered dose of rosuvastatin2. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile.

References:

1. Medicines and Healthcare Products Regulatory Agency (MRHA). New drugs and vaccines under intensive surveillance. http://www.mhra.gov.uk accessed June, 2007

2. Crestor SmPC http://www.medicines.org.uk

3. Schuster H, Barter PJ, Stender S, et al. Effects of switching statins on achievement of lipid goals: measuring effective reductions in cholesterol using rosuvastatin therapy (MERCURY I) study. American Heart Journal 2004; 147: 705-712

4. Middleton A et al. Achieving lipid goals in real life: the DISCOVERY-UK study. The British Journal of Cardiology 2006;13:72-76

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