Counterfeit versions of the cancer drug Avastin have made their way into the United States, federal drug safety officials are warning.
The counterfeit Avastin does not contain the active ingredient, bevacizumab, and is neither safe nor effective, according to a Genentech press release issued on February 14.
The FDA also issued a counterfeit Avastin warning and has sent letters to 19 medical practices in the United States that they believed purchased the fake Avastin.
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Learn MoreThe potentially dangerous counterfeit vials were sold by a foreign supplier that calls itself either Quality Specialty Products (QSP) or Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor for the company.
The FDA warned that patients injected with the product are not receiving needed therapy. There are also no guarantees that the counterfeit drugs are safe.
The counterfeit vials of Avastin 400 mg/16 mL can be identified in several ways. Avastin is sold in the U.S. under the Genentech label and the label is in English. The countefeit Avastin packages carry the Roche label and is in French. Genentech is a subsidiary of Roche, but Roche is not identified on a genuine Avastin label.
The fake Avastin also has lot numbers of B86017, B6011 and B6010. Real Avastin lot numbers are six digits with no letters. The fake Avastin has six digit expiration dates and manufacturing dates. Real Avastin does not have the date of manufacture and the expiration dates are formatted with a three-letter month abbreviation followed by the year (e.g. JUL 2014).
It is unclear how much of the counterfeit Avastin has been sent to the U.S. and the FDA has not publicly identified the country of origin. There have been no injuries or deaths reported in connection to the counterfeit Avastin.
Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.
In December 2010, the FDA decided to revoke Avastin’s approval to treat breast cancer and in June an FDA advisory committee backed that decision, ruling that the potential side effects of Avastin outweighed what they considered to be meager benefits in its treatment of breast cancer, but not in its other approved cancer treatments. Other potential Avastin side effects may include severe high blood pressure, heart attacks, heart failure, and the development of holes in the nose, stomach and intestines.
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3 Comments
kim discoveryJuly 28, 2015 at 6:48 pm
Ike, I work for Discovery Channel's production company on a project about counterfeit pharmaceuticals. I would love to talk to you about this topic and hear your story. if interested, my email is kimmie_lucas@discovery.com. Thank you.
GracielaMarch 24, 2012 at 5:24 am
My husband was diagnosed with bial dock cancer in July 2011. He was taking Simvastatin for his high cholesterol. This drug should be removed by the FDA. We expends our days in a cancer center, so I get to meet people with the same type of cancer or other digestive system cancers and many of this people were taking Simvastatin, what a coincidence????? I am extremely upset, my husband illness is a [Show More]My husband was diagnosed with bial dock cancer in July 2011. He was taking Simvastatin for his high cholesterol. This drug should be removed by the FDA. We expends our days in a cancer center, so I get to meet people with the same type of cancer or other digestive system cancers and many of this people were taking Simvastatin, what a coincidence????? I am extremely upset, my husband illness is a very painful type of cancer and there is no cure. We, the whole family is suffering a lot for the result of this "f" drug. I am at the point of suing Merk. THIS IS EXTREMELY PAINFUL.............. Please boicot this drug
ikeMarch 23, 2012 at 12:23 pm
My wife was treated with Avastin from March 2011 until her death in Dec 2011 @ Cancer Treatment Centers of America, Illinois. Her Doctor continuelly commented that the drugs were not working and that she didnt know why. She received avastin with each chemo injection every 12 days from mar 2011 to dec 2011.