The Food and Drug Adminstration and Genentech have reported that counterfeit Avastin is being distributed in the United States. The counterfeit medicine does not contain
bevacizumab, Avastin’s active ingredient.
The packaging is different from genuine Avastin marketed here by Genentech. It includes a Roche logo which isn’t on the real drug, along with different codes.
Avastin is not in shortage now, and there are adequate supplies to meet the need.
Patients being treated with Avastin are urged to let their doctors know immediately if they have unusual symptoms.
Genentech says,
If a patient taking Avastin is experiencing any side effects, they should contact their healthcare provider immediately. If the patient is experiencing any side effects that the healthcare provider thinks may be related to Avastin or that are different from those commonly associated with Avastin, the healthcare provider should immediately call FDA’s MedWatch Program (1-800-FDA-1088) or Genentech’s Drug Safety Department at 1-888-835-2555.
Nineteen US medical practices have been identified by the FDA as having bought the counterfeit Avastin and have been told to stop using it immediately.
February 21, 2012 at 1:01 pm, Laurettas said:
I was wondering when this fake Avastin was being used. My husband was on it in June and July last year and did end up with a massive blood clot in a leg vein. Should I contact the doctor?
February 21, 2012 at 6:25 pm, Kate Murphy said:
I don’t think it is clear when the counterfeit Avastin was first available in the United States.
It traveled here through a complex set of distributors before a red flag was raised by one of them and the drug was tested.
However, I doubt that counterfeit Avastin could have been a reason for your husband’s blood clot. Blood clots in veins occur in about 3 out of 10 patients with colorectal cancer at all stages and are about three times more common in stage IV patients.
Avastin also appears to increase risk for blood clots in veins. In a review of randomized clinical trials that included Avastin 12 out of 100 patients had some sort of vein clot and 6 out of 100 had a serious one. However, one writer responding to the article about the study pointed out that since Avastin increases the time that people live, they may simply have more time to get a clot.
I think it is important not to over react to the Avastin counterfeit story. Avastin is not a miracle cure for colorectal cancer. It does increase overall time that some people live compared to getting chemo alone, but it doesn’t cure colorectal cancer.
Better, I think to see this fake Avastin scare as a warning that it is possible for unregulated and potentially unsafe cancer drugs to get into the US system. Reliable cancer centers and oncology offices depend on knowing the “pedigree” of a drug from its initial manufacturer through the various distributors to the doctor and the patient.
At every step along the way, someone needs to be asking if a drug is real, whether it has been safely manufactured and kept under good conditions. And before any patient receives a drug, the pharmacist or doctor dispensing it should see its pedigree.
Whether or not Avastin or a counterfeit drug might have been involved in your husband’s leg clot is something that I cannot know. I am just a layperson with no access to his full records or way to interpret them. If this worries you, ask his doctor for more information.