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Avastin FDA Alerts

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

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 bevacizumab

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Aug 18, 2017

Audience: Health Care Professionals

[Posted 08/18/2017]

ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
 
BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.

RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.

Health care professionals  are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • 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.


[08/18/2017- Press Release - Bella Pharmaceuticals]

Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor

Sep 9, 2013

Audience: Consumer, Pharmacy, Patient, Health Professional

ISSUE: Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall. 

BACKGROUND: Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product label and corresponding medication name and lot number (see firm press release for lot numbers).

RECOMMENDATION: Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and healthcare providers with questions regarding this recall can contact Avella at (877) 738-0797 Monday through Friday between 6am and 6pm Pacific Standard Time or via e-mail at QA@avella.com.

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.fda.gov/MedWatch/report.htm
  • 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

[09/09/2013 - Firm Press Release - Avella Specialty Pharmacy]

Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection

Mar 20, 2013

Audience: Eye Care, Health Professional, Patient

ISSUE: Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.

BACKGROUND: This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see Press Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physician’s office setting and syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

RECOMMENDATION: Doctors that have product which is being recalled should stop using the Avastin immediately. Consumers with questions regarding this recall may contact Clinical Specialties by phone at 866-880-1915 or e-mail address at clinicalrx@bellsouth.net Monday through Friday between the hours of 10 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


[03/18/2013 - Press Release - Clinical Specialties]

 

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

Apr 3, 2012

Audience: Healthcare professionals

ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

 

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).  Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.

 

RECOMMENDATION: Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA.  The products should be retained and securely stored until further notice by the FDA.

 

FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or  
Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
Email - DrugSupplyChainIntegrity@fda.hhs.gov


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.fda.gov/MedWatch/report.htm
  • 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

 

[04/03/2012 - Drug Integrity and Supply Chain Security Statement - FDA]

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

Feb 14, 2012

Audience: Oncology, Pharmacy, Patient

ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. 

BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

  • are labeled with Roche as the manufacturer
  • display batch numbers that start with B6010, B6011 or B86017  

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.

 
RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

  • Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • 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

Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun

Dec 16, 2010

Audience: Oncology, Patients

ISSUE: FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

BACKGROUND: FDA is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

RECOMMENDATION: Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options. 

 

[12/16/2010 - News Release - FDA]
[12/16/2010 - Questions and Answers about Avastin - FDA]
[12/15/2010 - Avastin Decision Memo (PDF - 125KB) - FDA]

    

Avastin (bevacizumab) - Jul 14, 2008

Jul 14, 2008

Audience: Oncologists, other healthcare professionals

[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.

[July 11, 2008 - Dear Healthcare Professional Letter - Genentech]

Avastin (bevacizumab) - Apr 21, 2007

Apr 21, 2007

Audience: Oncological and other healthcare professionals

[Posted 04/21/2007] Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin. There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.

Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.

[April, 2007 - Dear Healthcare Professional Letter - Genentech]

Avastin (bevacizumab) - Sep 25, 2006

Sep 25, 2006

Audience: Oncological and neurological healthcare professionals

[Posted 09/25/2006] Genentech and FDA notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to inform healthcare professionals of 1] cases of a rare brain-capillary leak syndrome [reversible posterior leukoencephalopathy syndrome (RPLS)] and 2] postmarketing reports of nasal septum perforation.

RPLS is a neurological disorder associated with hypertension, fluid retention and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from 16 hours to 1 year after initiation of Avastin. Magnetic Resonance Imaging (MRI) is necessary to confirm the diagnosis of RPLS.

[September, 2006 - Updated Prescribing Information - Genentech]
[September, 2006 - Dear Healthcare Professional letter - Genentech]

More Avastin Resources