But about a year ago, one of the most popular statins, Baycol, was recalled by the Bayer Corp. because it had been associated with several dozen deaths as well as hundreds of adverse affects related to muscle weakness and breakdown. The recall left both patients and the medical community reeling and cast a heavy cloud over a family of medications that not much earlier had been heralded by some as miraculous.
It’s difficult to rebuild consumer confidence in a group of medications when one of its most popular members has been recalled, but a new consensus statement by several leading cardiology groups is attempting to do just that. The American Heart Association (AHA), the American College of Cardiology (ACC) and the National Heart, Lung and Blood Institute (NHLBI) have joined forces in issuing a statement that reiterates their prior position: when used appropriately and monitored carefully, statin drugs are safe and effective.
But what about those side effects–like muscle breakdown and kidney failure–that triggered the recall of Baycol? After additional analysis of the data and ongoing research on statin drugs, the AHA and ACC, along with the NHLBI, concluded that, though the drugs had side effects, they were safe if used properly. The three groups have each endorsed the safety of the drugs, but have also developed new guidelines to make statin use safer, like limiting dosages and making sure the patient’s progress is monitored carefully, as well as steering those at risk of side effects to other types of treatments.
These new guidelines are intended to help identify patients most at risk for muscle soreness and weakness. This at-risk group includes those who are extremely old, people who are frail and have small body frames, and those who have more than one severe chronic disease such as kidney or heart disease. Like most drugs, statins can interact with other medications, so the guidelines also recommend that doctors pay closer attention to their patients’ medication list and possible cross-reactions.
The advocacy group Public Citizen has petitioned the Food and Drug Administration to add a large warning to all statins about the potential for severe muscle weakness. However, up until now, the FDA hasn’t taken any action and, in fact, has stated that all statins already have muscle weakness listed as a potential side effect and says that there’s no indication that any other drug in the class has caused severe problems.
Some experts even believe that for all of the benefits that statins can offer, they’re underutilized. A major study, the Heart Protection Study (HPS), was conducted between the summer of 1994 and the fall of 2001 on more than 20,000 patients at 69 British medical centers. In the largest trial of its kind conducted to date, investigators found that statin therapy might also benefit healthier patients by lowering their risk of developing heart disease. The HPS researchers have also suggested that statins may be able to lower the lifetime risk of developing Alzheimer’s disease and could offer health benefits to postmenopausal women. Having three major cardiology groups endorse the safety and effectiveness of a class of medications sends an important message and should provide reassurance to those who are considering statins as a treatment option. But it’s also important that patients be as alert as their physicians when monitoring the potential side effects of these powerful medications.
