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Agrylin FDA Alerts

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

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 Agrylin

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

Parsippany, NJ. May 23, 2022 -- Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution – taking longer to dissolve once ingested -- may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Information about the affected lot is listed in the table below. It is packed in bottles with 100 Capsules. Teva distributed 4224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.

NDC

Lot #

Exp. Date

0172-5241-60 GD01090 05/2022

Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the customer recall letter (Anagrelide Recall 05 2022 Direct Accounts Letter Consumer Level 20 MAY 2022.pdf) and consumer recall letter (Anagrelide Recall 05 2022 _Patient Letter 20 MAY 2022.pdf)released by Teva.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical Related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event:
Contact Medical Information at: 888-838-2872, option 3, then, option 4
Live calls received: M - F, 9:00 AM - 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week
24 hrs. /day, 7 days/week or by email at druginfo@tevapharm.com.
Product Quality Complaint-related Questions:
Contact Quality Assurance Services: 888-838-2872, option 4
Live calls received: M - F, 9:00 AM - 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA


Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

December 9, 2020 -- Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide could increase the risk of clotting (blood coagulation) and clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells.

As the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The product subjected to the recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing the product.

NDC

Manufacturer

Product Description

Lot/Batch

Expiration Date

13668-462-01 Torrent Pharmaceuticals LTD Anagrelide Capsule USP 1mg,100-count bottles BFD1G001 12/2021

Anagrelide Capsules, USP were distributed nationwide to Torrent’s wholesale distributor and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time (Monday-Friday), voicemail available 8:00 am – 5:00 pm Eastern Time (Monday-Friday).
  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am - 5:00 pm Eastern Time, Monday-Friday).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA


Agrylin (anagrelide hydrochloride)

Shire and FDA notified healthcare professionals about changes to the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Agrylin (anagrelide hydrochloride), a medication approved for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events. Pharmacokinetic studies have revealed an 8-fold increase in total exposure (AUC) to anagrelide hydrochloride in patients with moderate hepatic impairment. Use of anagrelide hydrochloride has not been studied in patients with severe hepatic impairment. Labeling changes include the contraindication to the use of Agrylin in patients with severe hepatic impairment. The WARNINGS section describes the need for dosage reduction in patients with moderate hepatic impairment and the necessity of monitoring these patients carefully for cardiovascular effects.

[January 2005 - Letter - Shire Development Inc.]
[December 2004 - Label - Shire Development Inc.]


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