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Evamist FDA Alerts

The FDA Alert(s) below may be specifically about Evamist or relate to a group or class of drugs which include Evamist (estradiol).

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for estradiol

Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance

May 30, 2013

Audience: Consumer

 

[Posted 05/30/2013]

ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.

The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.

BACKGROUND: To date, Lowlite has received no reports of injury or illness associated with the use of the affected products.

RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Lowlite by phone at 888-323-7788 or 407-673-2222 from the hours of 9:00AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: Brian@olympiapharmacy.com. Patients who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[05/30/2013 - Press Release - Olympia Pharmacy]
[05/30/2013 - Recalled Product List - Olympia Pharmacy]

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Jul 29, 2010

Audience: OB/GYN, Patient

Keep Kids, Pets Away From Skin Sprayed With Evamist - FDA Consumer Update

ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may  experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement. 

BACKGROUND: Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. FDA is currently reviewing reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public when this review is complete. FDA and the company are also evaluating ways to minimize the risk.

RECOMMENDATION: Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. Additional information for Healthcare Professionals, Information for Patients, and a Data Summary are provided in the Drug Safety Communication at the link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/29/2010 - Drug Safety Communication - FDA]
[07/29/2010 - Keep Kids, Pets Away From Skin Sprayed With Evamist - FDA Consumer Updates]
[07/29/2010 - News Release - FDA]
[07/2009 - Evamist Prescribing Information - Ther-Rx Corporation]

    

Injectable drugs prepared by Urgent Care Pharmacy

Nov 18, 2002

Audience: All healthcare professionals

The Food and Drug Administration (FDA) announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia: Baclofen, Betamethasone, Bimix 30:1, (Phentolamine mesylate/papaverine), Clonidine, Estradiol, Hydromorphone HCl, Fentanyl, methylprednisolone acetate, Morphine Sulfate/Bupivacaine, Papaverine HCl, Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin), Testosterone cypionate, Testosterone/Estradiol.

[November 15, 2002 Talk Paper - FDA]

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