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Important Safety Information for Breast Cancer Awareness Month

Dr. Mario Trucillo

Last updated: October 20, 2016 8:00 pm

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October is National Breast Cancer Awareness Month, which means it is vital for us all to amplify the message of getting regular mammography screenings and raise awareness surrounding breast cancer issues.

Make sure to talk to your doctor about regular mammography screenings.  Based on your age and familial history, they will know best at what age to begin and the frequency of screenings in the future. The importance of the regular breast health check-ups is something that cannot be understated, but it’s also important to make sure the tests and devices being used are the safest, most effective options available. Below is information on two breast health tests that have had warnings issued by the FDA.

FDA Recalls on Breast Health Tests

FDA Recall Firm Press Release:  ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT) 1 Atossa Genetics Inc. initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall includes the MASCT System Kit and Patient Sample Kit. Distributors and customers should stop using affected products and return them to Atossa immediately. Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address concerns raised by the FDA in a warning letter received by Atossa in February 2013.

 ADVISORY

Patients should follow the recommendations and instructions of their physician with respect to breast cancer screening and diagnosis. If these devices are used as a substitute for recommended screening or diagnosis of breast cancer, FDA is concerned that patients may choose to forgo recommended mammograms and necessary biopsies. 

Products affected by this recall are listed in the table below:

Product Code Part Number Description Lot Number
AG-MASCT 9002528 MASCT System Kits All
AG-MASCT 9002528MD MASCT System Kits All
DTG-MASCT 9002587 Clarity System Kits All
AG-FC5 9002513 MASCT Patient Sample Kits All
AG-FC5 9002513MD MASCT Patient Sample Kits All
DTG-FC5 9002614 Clarity Patient Sample Kits All
NRLBH-5 9002717MD Nipple Aspirate Fluid Laboratory Kit All

 

Distributors and customers should contact Atossa at 800-351-3902 to obtain instructions on how to return these products. Customers with questions may contact the company via telephone at 1-888-219-4629 at any time. Any problems experienced with the use of this product may be reported to the FDA: at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm Online (form available to fax or mail), or call FDA 1-800-FDA-1088

Calcium-Channel Blockers and Breast Cancer: Is There a Connection?

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Calcium channel blockers, which include amlodipine (Norvasc), diltiazem (Cardizem, Tiazac), nicardipine (Cardene SR), nifedipine (Procardia), nisoldipine (Sular), and verapamil (Calan, Verelan, Covera-HS), are among the most commonly prescribed – and taken – drugs for high blood pressure. Nearly 100 million prescriptions are filled a year. But a report published in JAMA Internal Medicine in September 2013 suggests that using the medication for 10 or more years could significantly increase a woman’s risk of breast cancer.

Researchers from the Hutchinson Cancer Research Center in Seattle conducted an “observational study,” which means they reviewed records on about 2,500 women, a third of whom had invasive ductal breast cancer (IDC), a third of whom had invasive lobular breast cancer (ILC), and a third of whom had no cancer (the control group). All had taken or were currently taken calcium channel blockers. They also interviewed 80 percent of the women about a variety of topics, including their breast cancer risk factors and medical and family history.

Researchers found that women who had taken a calcium channel blocker for 10 or more years had a 2.5-fold increased risk of IDC and a 2.6-fold increased risk of ILC. Women currently taking short-acting formulations (verapamil,
diltiazem, nifedipine, and nicardipine) had a 3.7-fold increased risk of IDC and a 3.6-fold increased risk of ICS, although the researchers couldn’t say how long the women had take the drug to develop the increased risk (most people today take long-acting forms).

The study isn’t the first to suggest a link between breast cancer and calcium channel blockers; four other studies found the same thing. However, eight other studies found no link. None of the studies, however, looked at data beyond five years, and most were relatively small.

No one really knows just why this class of drugs might increase breast cancer risk. One hypothesis is that the drugs prevent abnormal cells from committing apoptosis, a kind of “cellular suicide.” That could allow aberrant cells to divide and, possibly, become cancerous.

Should you stop taking calcium channel blockers?

So should you stop taking your calcium channel blocker medications? Absolutely not. As the author of an editorial in the same issue of the journal wrote: “… these data are from an observational study, which cannot prove causality and by itself cannot make a case for change in clinical practice.”

In other words, just because there appears to be an increased link between calcium channel blockers and breast cancer risk, it could simply be coincidence or related to something completely different. The only way to know for sure would be to conduct a long-term study in which researchers follow a group of women taking the medication for 10 or more years and compare the rate of breast cancer in that group to a similar group of women who didn’t take the medication. It’s unlikely such an expensive, complex trial would be conducted. If you’re still worried, though, make an appointment to talk to your doctor. There are several other classes of drugs for high blood pressure that may work just as well – without causing you any anxiety.

  1. U.S. Food and Drug Administration. ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT. Updated October 4, 2013, available at: http://www.fda.gov/Safety/Recalls/ucm370782.htm. Accessed on October 4, 2013