Statins, prescribed to help reduce the risk of potentially deadly cardiovascular disease, are the most-prescribed drug in the UK, taken by around six million people every day.
Up to a fifth of patients taking the medicine report symptoms including muscle pain, poor sleep, memory loss and erectile dysfunction.
Professor Sever was highly critical of the Medicines and Healthcare products Regulatory Agency (MHRA) for “jumping the gun” by insisting on the side effect warnings in 2009.
The agency had acted on observational reports not based on robust science, he maintained. did not make a profound value judgment based on the evidence,” the professor said.
Any new significant information on the efficacy or safety of statins will be carefully reviewed and action will be taken if required, including updates to product labelling.” Professor Sir Nilesh Samani, medical director at the British Heart Foundation, pointed out that muscle aches, memory loss, sleep disturbance and erectile dysfunction occurred in the general population for a “whole variety of reasons”.
Reports of side effects had led to a fall in the number of patients taking statins, and a reluctance among some doctors to prescribe them, with serious consequences, he said. I would love to see these side effects removed.” The study was conducted in two phases, the first of which included 10,180 patients aged 40 to 79 from the UK, the Irish Republic and Scandinavia.
“We would hope that the MHRA will withdraw that request that these side effects should be listed.” He stressed that the muscle-related symptoms investigated in the study had no connection with genuine but uncommon side effects known to be caused by taking statins.
These included myopathy, which results in muscle weakness, and the very rare but serious muscle-wasting condition rhabdomyolysis.
The blinded phase of the trial also found no significant difference in rates of erectile dysfunction or cognitive impairment between patients in the active treatment and placebo groups, while sleep disturbance turned out to be less, not more, common among “blinded” patients taking statins.
The news comes after warnings that millions of people in Britain are being given the wrong dose of statins, putting them at a higher risk of heart attack.
Stefan – a young man from England – is one of those unlucky people. They put an emphasis on skin dryness, but the list of the side effects I was shown was short. They also focused on telling me about the risk of getting pregnant. I also had to sign a contract, as did my Mum, to state that I’d been warned of the risks and what not.