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Nutropin AQ FDA Alerts

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

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 somatropin

Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death

Aug 4, 2011

Audience: Pediatrics, Endocrinology

[UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified a number of study design weaknesses that limit the interpretability of the study results. FDA also reviewed the medical literature, as well as reports from the Agency's Adverse Event Reporting System (AERS). These additional data sources did not provide evidence suggestive of a link between recombinant human growth hormone and an increased risk of death.

Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations. 

FDA is continuing to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. FDA will update the public when new information is available.

 

[Posted 12/22/2010]

ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature and children small for gestational age. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Omnitrope, Saizen, and Tev-Tropin.

RECOMMENDATION: Do not stop taking recombinant human growth hormone without talking to your healthcare professional. At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.

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:

 

[08/04/2011 - Drug Safety Communication - FDA]
[12/22/2010 - Drug Safety Communication - FDA]

 

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Jan 28, 2011

Audience: Pharmacy, Consumer, Risk Manager

[UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be used.

 

[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the defective Triad alcohol pad. Relistor sold in single vials also is unaffected by this recall. Pfizer and Progenics advise patients using the Relistor kit not to use the Triad alcohol prep pads included in the Relistor packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their Relistor injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.

 

[UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States. Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.
 
Bayer is instructing patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol. 

 

[UPDATED 01/14/2011] The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall.

 

[Posted 01/06/2011]

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.

RECOMMENDATION: If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.

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:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[01/24/2011 - Press Release - GlaxoSmithKline]
[01/25/2011 - Press Release - Pfizer Inc. and Progenics Pharmaceuticals, Inc.]
[01/13/2011 - Press Release - Genentech]
[01/08/2011 - Press Release - Bayer HealthCare]
[01/06/2011 - Press Release - Triad Group] 

    

Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death

Dec 22, 2010

Audience: Pediatrics, Endocrinology

ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature and children small for gestational age. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

RECOMMENDATION: Do not stop taking recombinant human growth hormone without talking to your healthcare professional. At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.

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:

 

[12/22/2010 - Drug Safety Communication - FDA]

    

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