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Reminyl FDA Alerts

The FDA Alerts below may be specifically about Reminyl or relate to a group or class of drugs which include Reminyl.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Reminyl

Reminyl (galantamine hydrobromide) - Apr 1, 2005

Ortho-McNeil Neurologics modified the PRECAUTIONS section of the Prescribing Information for Reminyl, approved only for the treatment of mild to moderate Alzheimer’s Disease. The changes provide new safety information regarding the results of two randomized, placebo-controlled trials of 2 years duration in subjects with mild cognitive impairment (MCI). A total of 13 subjects on REMINYL (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population. About half of the REMINYL deaths appeared to result from various vascular causes (myocardial infarction, stroke), and sudden death.

[March 31, 2005 - Letter - Ortho-McNeil Neurologics]


Reminyl (galantamine hydrobromide) - Oct 26, 2004

[October 26, 2004] FDA, Janssen Pharmaceutica Products, and Johnson & Johnson Pharmaceutical Research & Development notified healthcare professionals of reports of medication errors involving confusion between Reminyl, a drug approved for the treatment of mild to moderate dementia of the Alzheimer's type, and Amaryl (glimepiride), a product of Aventis Pharmaceuticals, indicated for the treatment of non-insulin dependent (Type 2) diabetes mellitus. These reports include instances in which Reminyl was prescribed but Amaryl was incorrectly dispensed and administered instead, leading to various adverse events including severe hypoglycemia and one death.

[UPDATE 12/23/2004] Letter to Pharmacists from Aventis Pharmaceuticals posted.

[October 15, 2004 - Letter to Healthcare Professionals - Janssen]
[October 19, 2004 - Letter to Pharmacists - Janssen] PDF Format
[November 5, 2004 - Letter to Pharmacists - Aventis] PDF Format


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