Statins side effects warning when combined with other drugs: regulator

The statin craze seems to be slowly winding down at long last

Hundreds of thousands of people taking a common statin are to have their dose reduced due to fears over side effects, it has emerged.

Medicines regulators have warned that patients taking simvastatin at the same time as other drugs used to reduce high blood pressure are likely to suffer more aches and pains.

The MHRA has produced a patient leaflet for the first time to inform people of the changes being made.

Studies have shown that patients taking simvastatin, particularly the 40mg dose which is the most commonly prescribed in England, suffered more problems if they were also on amlodipine and diltiazem.

These are used to treat high blood pressure and chest pain associated with heart disease, and they are often prescribed with simvastatin.

The side effects are those usually associated with statins, including muscle problems such as pain, tenderness, weakness and cramps and more rarely muscle breakdown leading to kidney damage.   These occurred more frequently when patient were on both drugs at the same time.

Regulators have said patients taking the combination should not stop them and talk to their doctor at their next routine appointment.

Doctors may lower the simvastatin dose as the side effects were less common when patients were on a 20mg dose, or switch them to another statin.

An MHRA spokesman said: "The MHRA is committed to public health and continuously monitors the safety of all medicines.

"We have recently published information on dosing recommendations for simvastatin which were updated due to a small risk of an increase in side effects when it is used at higher doses in conjunction with amlodipine or diltiazem.

"This advice is intended to optimise the proven beneficial effects of statins while minimising any adverse effects and should not be a reason for stopping statin treatment. We have advised that patients continue their treatment and discuss this with their doctor at their next routine appointment.

"The updated information has been highlighted in our first Drug Safety Update article designed exclusively for patients, with the aim that people taking these medicines can understand why their statin treatment may have changed."

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Canada’s Organic Certification System is an Emperor with No Clothes

Lacks field testing, unannounced inspections or meaningful definitions

The Frontier Centre for Public Policy released today a policy study examining the system for testing organic products – or the lack thereof – in Canada.

The authors show the circularity in a process that claims to establish standards for organic foods. Since the Canadian organic standard has no testing clause, the CFIA has essentially defined an organic product as any product that has been certified thus, emptying the concept of any real meaning. No mention is made of safety, purity, nutrition, or sustainability.

This has important implications for Canadian consumers and the country’s $2 billion organic food industry. It is also important because the organic industry often points fingers at conventional food for its supposed “impurity” and makes claims that conventional food products that are not being systematically tested.

The report is not an attack on organic farmers or the many dedicated men and women who work in the industry. Rather, the report hones in on the process of certifying foods as organic: “True rank-and-file organic farmers […] have no affinity whatsoever for the class of self-appointed, urban political activists who claim to represent them.”  “It comes as no surprise that with more than $2-billion per annum at stake, the Canadian organic lobby is dead set against organic field testing and will go to any lengths to discredit anyone who promotes the application of the scientific method to the organic industry,” said the authors.

The United States’ federal organic standards allow for routine, unannounced testing of organic crops, livestock, and stored product. Some states voluntarily carry out mandatory, scientific organic field testing at the local level. But, in Canada, the only requirement is an exhaustive review of paperwork through a CFIA-accredited organic certifier, some of which are even off shore.

Canada’s lax testing standards are making this country susceptible to foreign organic importers, and risk of undermining Canada’s food producers.

The authors also show how a science-based system would cost less than a tenth of the cost of running the current organic certification system, and propose a more decentralized means of making testing and certification meaningful and effective.

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