February 21, 2012

The U.S. Food and Drug Administration (FDA) issued a safety alert on February 20, 2012 regarding a counterfeit (fake) cancer medication that may have entered the U.S. from overseas that does not contain the required active ingredient. The only FDA-approved version of the cancer drug Avastin is marketed by a company called Genentech, which is part of the larger drug company Roche. (Roche markets Avastin for use outside of the United States.)

The FDA issued 19 letters to medical practices in the United States, warning them that they may have purchased the unapproved, counterfeit Avastin from a source outside of the United States. The unapproved Avastin was purchased by the medical practices from a foreign supplier known as Quality Specialty Products or Montana Health Care Solutions. The Tennessee company Volunteer Distribution is a distributor for Quality Specialty Products.

The counterfeit Avastin has been confirmed to not contain the active ingredient of Avastin, which is bevacizumab. Therefore, patients who receive the counterfeit Avastin are not receiving the medication that they were prescribed and are not receiving the benefit of the real Avastin.

Avastin is an injectable cancer medication used to treat various forms of cancer. Avastin is packaged in vials. The labels on the counterfeit vials contain the Roche logo whereas the FDA-approved Genentech vials do not. The counterfeit vials may contain the batch numbers that start with B6010, B6011, or B86017 (the FDA-approved Genentech vials have a 6-digit numeric batch number and expiration dates expressed in a 3-letter month and 4-digit year, such as JAN 2014).

The FDA-approved version of Avastin is not currently in short supply in the United States.


What Is Avastin Used For?

Avastin (bevacizumab) is a cancer drug that is in a class of medicines known as antiangiogenic agents that work by stopping the formation of blood vessels to tumors that may slow the tumor’s growth and stop the spread of the tumor. Avastin is used in the treatment of colon and rectal cancer that has spread to other parts of the body, certain lung cancers, and a type of brain cancer known as glioblastoma that has already been treated with other cancer medications. Avastin is also used in combination with another drug to treat renal cell carcinoma that has already spread to other parts of the body.

Avastin was used in the past to treat breast cancer patients but the FDA determined that its risks in use for breast cancer did not justify the benefit in most cases. (See our blog posting for November 21, 2011 entitled, “FDA Withdraws Approval Of Avastin For Use In Treating Metastatic Breast Cancer”)

Avastin is administered slowly into a vein once every 14 days to treat colon cancer, cancer of the rectum, renal cell cancer, or glioblastoma, and once every 3 weeks to treat certain lung cancers. The first dose is given over a period of about 90 minutes to check for reactions to the medication and subsequent doses are usually given over 30 to 60 minutes.


Drug shortages are a continuing and worsening problem in the United States (see our blog posting for October 1, 2011 entitled, “Drug Shortages In The U.S.”; our blog posting for November 3, 2011 entitled, “Drug Shortages: Get Your Drugs While You Still Can!”; and, our blog posting for December 17, 2011 entitled, “Drug Shortages Are Getting Even Worse!”).

Unscrupulous drug manufacturers, suppliers, and distributors see a potential to earn outrageous profits by either stockpiling drugs subject to shortages or by producing/providing counterfeit versions of drugs that are either in short supply or intended to be substituted for the brand name versions that are exceedingly expensive.

Price gouging hurts patients who cannot afford their necessary and life-extending medications. Counterfeit drugs either do not benefit patients or harm patients who do not receive their required medications. We believe that the price gougers and the counterfeiters should be required to pay civil fines and restitution in amounts greater than their profits from their wrongdoing and that they should also be subjected to criminal prosecution and sentenced to long prison terms.

If you or a loved one have been injured by a drug, the advice of a medical malpractice attorney is critical in determining your legal rights and whether you have a viable claim for compensation.

Click here to visit our website  or telephone us toll free at 800-295-3959 to be connected with medical malpractice lawyers in your state who may be able to investigate your possible claim and file a claim on your behalf, if appropriate.

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