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Drug Safety and Availability Categories
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Safety Alerts
2011
FDA Issues Alert on the Use of Multaq (dronedarone) in Patients with Permanent Atrial Fibrillation (07/22/2011) — The U.S. Food and Drug Administration alerts healthcare professionals to stop prescribing Multaq to patients with permanent atrial fibrillation and advises patients taking Multaq to talk to their healthcare professional about whether they should continue to take the drug for non-permanent atrial fibrillation. Learn more »
FDA Issues Alert About Dabigatran (Pradaxa) Storage and Handling Requirements (04/01/2011) —The U.S. Food and Drug Administration has alerted the public to important storage and handling requirements for dabigatran etexilate mesylate (Pradaxa) capsules. Learn more »
FDA Warns Severe Liver Injury Associated with the use of Multaq (dronedarone) (01/18/2011) — The U.S. Food and Drug Administration has alerted health care professionals and patients about cases of rare, but severe liver injury in patients treated with dronedarone (Multaq). Learn more »
2010
FDA Announces Midodrine Stakeholders Teleconference (12/8/2010) — The U.S. Food and Drug Administration has announced that it will hold a conference call on December 15 to discuss the data necessary to establish the efficacy of midodrine. Stakeholders are encouraged to participate in order to discuss information they might share ortheir willingness to assist anyone planning to conduct clinical trials on midodrine. Learn more »
FDA Responds to Society Letter on Midodrine (10/27/2010) —The U.S. Food and Drug Administration (FDA) has responded to a Heart Rhythm Society letter regarding consumer access to the drug Midodrine Hydrochloride. The FDA's response included a clarification of its proposal to remove the drug, as well as an announcement that there will be a public hearing for the drug's manufacturers to present clinical evidence. Learn more »
Society Urges FDA Not to Remove Midodrine Hydrochloride from Market (08/20/2010) —On August 16, 2010, the FDA proposed withdrawing approval of midodrine hydrochloride (used to treat the low blood pressure condition orthostatic hypotension) because required post-approval studies that verify the clinical benefit of the drug have not been done. The Society has urged the agency to not remove the drug from the market. Learn more »
FDA Safety Alert: Alli 60 mg capsules (120 count refill kit): Counterfeit Product (01/25/2010) — The FDA issued an update to a January 18, 2010 safety alert with information on laboratory analysis of sibutramine levels in Alli 60 mg capsules (120 count refill kit). The excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack. Learn more »
2008
FDA Safety Alert: Risks of Combining Certain Cholesterol and AF Drugs (08/11/2008) — The FDA issued a safety alert to physicians, noting that combining certain cholesterol and atrial fibrillation medications can result in a rare, and sometimes fatal, muscle wasting condition called rhabdomyolysis. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Learn more »
Recalls
2010
Bristol-Myers Squibb Initiates a Voluntary Recall of Coumadin (07/12/2010) — Bristol-Myers Squibb has initiated a voluntary recall of certain lots of physician sample and hospital unit dose of Coumadin® 1 mg blister pack tablets. The nationwide recall is a precautionary measure based upon the company’s determination that some of the tablets, over time, may not meet specification for isopropanol, used to maintain the active ingredient in the crystalline state, which could affect the therapeutic levels of the active ingredient. No side effects have been reported. Learn more »
2008
Digitek® Class I Recall — Potency Concern Cited (04/29/2008) — Actavis Totowa LLC is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. Digitek® is used to treat heart failure and abnormal heart rhythms. Learn more »
Discontinuations
2008
Supplies of Procanbid Depleted (06/20/2008) — the Society has confirmed that supplies of PROCANBID (see below) are depleted and that there is no alternative generic drug on the US market. Physicians should contact patients on this therapy. Learn more »
King Pharmaceuticals' Procanbid to be Discontinued (01/15/2008) — Based on a business decision (not drug safety or efficacy), King Pharmaceuticals®, Inc. issued notification to physicians that PROCANBID (Procainamide Hydrochloride Extended-Release tablets, 500mg, 1000mg) will no longer be available. Learn more »
2007
Shire Announces Ethmozine will be Available until December 31, 2007 (Summer 2007) — Based on a business decision (not drug safety or efficacy), Shire issued notification to physicians Ethmozine (moricizine hydrochloride) would no longer be available as of August 28, 2007. Since discontinuation of drug therapy should be done under medical supervision and one month notice to physicians to transition patients to alternative therapies is insufficient to prevent possible harm, the Heart Rhythm Society worked with Shire Pharmaceuticals to extend the availabily for 6 months. Learn more »
Shortages
2010
TIKOSYN® (Dofetilide) Shortage: 60 count bottles of 125 mcg (01/22/2010) — Pfizer has informed health care professionals of an immediate shortage of 60 count bottles of TIKOSYN® 125 mcg. This product shortage resulted from Pfizer’s efforts to use the 125 mcg to alleviate prior shortage issues with 250 and 500 mcg and not the result of any efficacy or safety issues with TIKOSYN. Learn more »
2009
TIKOSYN® (Dofetilide) Shortage: 60 count bottles of 250 mcg and 500 mcg (12/09/2009) — Pfizer has informed the Heart Rhythm Society and health care professionals of a shortage of 60 count bottles of TIKOSYN® 250 mcg and 500 mcg. It is expected that the shortage of TIKOSYN® 250 mcg and 500 mcg will begin in early December 2009. This product shortage is a result of a manufacturing issue and not the result of any efficacy or safety issues with TIKOSYN®. Learn more »
2008
TIKOSYN® (Dofetilide) Shortage Update (01/21/2008) — Pfizer announced on January 18, 2008 that there is a shortage of the drug Tykosyn 0.5mg and 0.25mg . The shortage is not the result of any efficacy or safety concern with Tikosyn. An unforeseen manufacturing issue coupled with distribution regulations for Tikosyn has resulted in the product outage. The shortage was resolved as of February 1, 2008. Learn more »
