A prominent watchdog group is warning against use of the hypertension drug Bystolic, indicating that it could cause severe breathing problems and that it appears to provide no advantage over taking cheaper, more thoroughly studied hypertension drugs.
In the latest edition of Public Citizen’s Worst Pills, Best Pills newsletter (subscription required), the consumer advocacy group urges patients to explore other means of lowering blood pressure, including changes to diet, exercise and decreased salt and alcohol intake, instead of taking Bystolic. Public Citizen warns that consumers should wait until at least 2015 before using the drug.
Bystolic (nebivolol) was approved in December 2007 by the FDA for the treatment of hypertension. It is a member of a class of drugs known as beta-one selective beta blockers. Public Citizen recommend that new drugs should be on the market for seven years before readers use the medications, allowing enough time for postmarketing analysis to reveal potential long-term side effects.
At high doses, the drug could lose its selectivity and block beta-two receptors as well, the group warns. This could cause problems among patients with asthma and chronic obstructive pulmonary disease (COPD), because other non-selective beta blockers, such as Normodyne and Trandate, can inhibit muscle relaxation throughout the body and the upper airway, impairing bronchial and bronchiolar dilation.
The drug’s label warns that it should be avoided by users suffering from heart failure, slow or irregular heartbeat, severe liver damage or who have asthma and COPD. Common side effects also include heart failure and fatigue.
A study published last October in the Journal of the American Medical Association (JAMA) found that beta blockers, often prescribed to prevent strokes and heart problems, may provide little benefit. Researchers found that statistically the drugs did not appear to have any benefit in lowering heart attack, cardiac arrest or stroke rates. However, they warned that more randomized drug trials needed to be undertaken to get a better sense of the class’s efficacy.