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AndroGel FDA Alerts

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

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 AndroGel

FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

Apr 26, 2022 | Audience: Patients, Health Care Professionals, Veterinarians, Animal Owners/Caretakers

April 26, 2022 --FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.

APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy.

The recalled drugs include “gonadorelin acetate,” “testosterone cypionate in grapeseed oil,” “testosterone cypionate/anastrozole in grapeseed oil,” “testosterone cypionate/DHEA in grapeseed oil,” and “testosterone cypionate/propionate in sesame seed oil” for human use, and “cyclosporin” and “tacrolimus” for animal ophthalmic use. These products were compounded between December 21, 2021, and March 7, 2022. The recalled drugs, lot numbers, and do-not-use beyond date - the date when the compounded drug should no longer be used - are listed here.

Since the company initiated the recall and began contacting patients using the recalled drugs, FDA has received adverse event reports from APS Pharmacy regarding injection site reactions, such as pain, redness, swelling and abscesses requiring medical treatment; and systemic reactions, which include fever, chills, and rash. To date, FDA has received two reports of adverse events occurring in animals following use of the recalled animal ophthalmic products.

Patients should not use, and animal owners/caretakers should not administer, the recalled drugs from APS Pharmacy. If they are not sure if they have a recalled drug, they should contact APS pharmacy to confirm. Patients who have received these recalled drugs from APS Pharmacy should contact their health care professional. Animal owners/caretakers should contact their veterinarian as appropriate.

Health care professionals and veterinarians should immediately check their medical supplies, quarantine any recalled drugs from APS Pharmacy, and not administer or provide them to patients or animals.

FDA urges health care professionals and consumers who obtained recalled drugs from this company to make alternative arrangements to obtain medications from sources that meet applicable quality standards.

Health care professionals and consumers should report adverse events or side effects related to the use of products from APS Pharmacy to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Veterinarians and animal owners/caretakers should report adverse events or side effects in animals related to the use of these products to FDA’s Center for Veterinary Medicine. Please visit How to Report Animal Drug and Device Side Effects and Product Problems for more information.

Source: FDA

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

Oct 25, 2016 | Audience: Patient, Endocrinology, Internal Medicine

ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. 

The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia. 

The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.     
 
BACKGROUND: Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection.

RECOMMENDATION: 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:

[10/25/2016 - Statement - FDA]

Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots

Jun 20, 2014 | Audience: Pharmacy, Primary Care

[Posted 06/20/2014]

ISSUE:  FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

BACKGROUND: The risk of venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots, to ensure this risk is described consistently in the labeling of all approved testosterone products.

RECOMMENDATION: Note - This new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. FDA is currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in a January 31, 2014 MedWatch Safety Alert.

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:


[06/20/2014 - FDA/CDER Statement]

Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events

Jan 31, 2014 | Audience: Cardiology, Urology, Family Practice

[Posted 01/31/2014]

ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.

BACKGROUND: Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.

RECOMMENDATION: At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.

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:

[01/31/2014 - Drug Safety Communication - FDA]

University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance

Sep 8, 2013 | Audience: Consumer, Pharmacy, Patient, Health Professional

ISSUE:  University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level (refer to Recall Notice for a detailed product list with affected lot numbers and expiry dates).  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

BACKGROUND: The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013.The preparations would have been sold, directly to customers by pick up and by mail. 

RECOMMENDATION:  Customers that have product which is being recalled should stop using it and contact University Compounding Pharmacy to arrange for return of unused product. Customers with questions regarding this recall can contact University Compounding Pharmacy at 1875 Third Ave, San Diego CA 92101 619-683-2005.

Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these preparations.

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:


[09/08/2013 - Recall Notice - FDA]

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]

Testosterone gel products (AndroGel and Testim)

May 7, 2009 | Audience: Urological and Endocrinological healthcare professionals, pediatriciansFDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

[May 07, 2009 - News Release - FDA]
[May 07, 2009 - Approval Letter - Androgel - FDA]
[May 07, 2009 - Approval Letter - Testim - FDA]

Injectable drugs prepared by Urgent Care Pharmacy

Nov 18, 2002 | Audience: All healthcare professionalsThe 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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