A temporary shortfall in the supply of carvedilol may cause some patients to have difficulty filling their prescriptions, the drug's maker, GlaxoSmithKline, announced in a “Dear Healthcare Professional” letter.
The company is working diligently to resolve the situation, the letter states.
Coreg (carvedilol) is indicated for mild and moderate heart failure and for essential hypertension, as well as for severe heart failure and post-myocardial infarction left ventricular dysfunction. It is the only β-blocking drug approved by the U.S. Food and Drug Administration for treatment of the latter two indications.
Because of the life-threatening nature of these two indications, GlaxoSmithKline (GSK) is working to provide emergency overnight shipments to local pharmacies of such patients who cannot get prescriptions filled.
To conserve available drug for those with the greatest need, the company asked that new patients with mild or moderate heart failure or essential hypertension not be started on Coreg and that a switch to Toprol-XL (metoprolol) be considered for those with mild to moderate heart failure who are already being treated with carvedilol; metoprolol is the only other β-blocker approved for use in this population.
Patients who are switched or who stop carvedilol treatment should be monitored carefully, the letter states.
Newly introduced documentation procedures are the cause of the delays in the release of the drug, according to GSK. The procedures were implemented as part of a consent decree with the FDA that was signed last year by GSK after the company was cited for manufacturing deficiencies associated with Paxil CR (paroxetine) and Avandamet (rosiglitazone and metformin), which are produced at the same Cidra, Puerto Rico, manufacturing facility that makes Coreg.
The consent decree requires third-party review documentation prior to any product release from the facility, and this process has delayed release of the drug and caused the “spot shortages,” according to a company spokesperson, who predicted the problem will be resolved in a matter of weeks rather than months.
The delays are also affecting Paxil CR and Avandamet supplies, but a “Dear Healthcare Professional” letter was not issued in regard to these drugs, because unlike severe heart failure patients and patients with post-myocardial infarction left ventricular dysfunction, patients on these drugs have alternative treatment options and are not generally considered to have life-threatening illness, she explained.
For information regarding the Coreg supply or to work with GSK to get emergency shipments of Coreg to local pharmacies for patients in need of the drug, call 888-825-5249.