FDA Safety Communications: Mammogram Quality Problems

Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems

AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient

ISSUE: FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) did a review of mammograms performed by the Richard D. Adelman, M.D., Family Medicine practice between August 25, 2012, and August 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility's accreditation on November 5, 2014. On November 18, 2014, the FDA required the facility to notify all patients who received mammograms at its facility any time after August 24, 2012 about these problems, and to stop performing mammography.

This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at an Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up. Patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D, Family Medicine practice.

BACKGROUND: Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States.  This facility did not meet standards for mammography quality under the Act. The facility may not perform mammography due to the revocation of its accreditation by the ACR and its MQSA certification being no longer in effect until the accreditation is reinstated.

RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Richard D. Adelman M.D., Family Medicine practice any time after August 24, 2012:

• If you have had a more recent mammogram at an MQSA-certified facility since then, you should follow the recommendations from that facility.
• If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines:
• Consider requesting your mammogram and copies of your medical reports from Richard D. Adelman, M.D, Family Medicine practice and have your mammogram reviewed at an MQSA-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute's (NCI) information number at 1-800-422-6237.
• If you need a repeat mammogram and your health insurance will not pay for it, you can call the NCI information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that provide free or low-cost mammograms.
• If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439723.htm

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Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

A Possible Culprit of Alzheimer’s Disease Identified

A Study of Thousands of Brains Reveals Tau as Driver of Alzheimer’s Disease

Postmortem analysis of almost 1,400 brains implicates tau, not amyloid, buildup driving memory loss.

TUESDAY, March 24, 2015 (HealthDay News) -- Abnormal tau protein collecting in the brain may be the main cause of Alzheimer's disease, a new study claims.

Another protein called amyloid accumulates as Alzheimer's progresses, but is not the primary culprit behind the devastating memory loss that is the hallmark of the disease, Mayo Clinic researchers report. (read more >>)

Click Here to Listen to Dr. Melissa Murray, Mayo Clinic, Jacksonville, Fla

Alzheimer's Disease

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FDA Warns of Serious Slowing of the Heart Rate for Amiodarone and Harvoni with Another Direct Acting Antibiral Drug

The U.S. Food and Drug Administration (FDA) 

The FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. We are recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone. Patients should not stop taking any of their medicines without first talking to their health care professionals.

Harvoni and Sovaldi are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver problems, including cirrhosis or liver cancer. These drugs reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying within the body.

Our review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. Information about this serious risk of bradycardia has been added to the Warnings and Precautions, Drug Interactions, and Postmarketing Experiencesections of the drug labels for Harvoni and Sovaldi. We will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, we recommend heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.

For more information please visit: Harvoni and Sovaldi

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Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

A New Study Suggests that Vitamin D Might Slow Prostate Cancer

 New Findings about Vitamin D Concerning Prostate Cancer

MONDAY, March 23, 2015 (HealthDay News) -- Vitamin D supplements may slow or prevent low-grade prostate cancer from progressing, a small new study suggests.

"Vitamin D decreases inflammation in tissues, and inflammation is a driver of cancer," explained Bruce Hollis, the study's lead researcher and a professor of pediatrics, biochemistry and molecular biology at the Medical University of South Carolina in Charleston.

For the study, researchers randomly assigned 37 men who elected to have their prostate removed to receive either 4,000 international units (IU) of vitamin D or an inactive placebo daily for 60 days before their operation.

But it's too early to make blanket recommendation, expert says.

Read more here >>

 Bruce W. Hollis, PhD, Medical University of South Carolina shares the results of a recent trial including identifying the vitamin D level needed to protect the prostate gland.

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FDA Medication Guide

 FDA Medication Information

Medication Guides are paper handouts that come with many prescription medicines.

The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:

• certain information is necessary to prevent serious adverse effects
• patient decision-making should be informed by information about a known serious side effect with a product, or
• patient adherence to directions for the use of a product are essential to its effectiveness.
  

Opdivo (nivolumab) [3/2015 version]
Belsomra  (suvorexant) [2014 version]
Lynparza (olaparib) [2014 version]

Learn more from FDA here >> 

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FDA Concludes "Inconclusive" for Schizophrenia Drug Zyprexa Relprevv and Patients' Death

The U.S. Food and Drug Administration (FDA) has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. 

The study results were inconclusive. We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed, we are not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.

Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). PDSS is a serious condition with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma), delirium, or both. In clinical trials, cases of PDSS were observed within 3 hours after giving an intramuscular injection of Zyprexa Relprevv, although no deaths were reported. To reduce the risk of PDSS, there is also a Risk Evaluation and Mitigation Strategy (REMS) for Zyprexa Relprevv to ensure that patients are observed by health care professionals at a certified facility following injection.

Following the deaths of the two patients who received appropriate doses of Zyprexa Relprevv, FDA requested the drug’s manufacturer, Eli Lilly and Company, to conduct an animal study to test whether movement of olanzapine into blood after death could lead to higher-than-expected blood levels of the drug. The study showed that some animals had increases in drug levels in the blood after death, which could account for the higher-than-expected blood levels found in the two patients who died. For more information please visit: Zyprexa Relprevv

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

Lentiviral Vector Manufacturer, Theravectys, Granted a Manufacturing Establishment by the ANSM in Frence

The French National Agency for Medicines and Health Products Safety (ANSM) granted a GMP pharmaceutical establishment, Theravectys, to produce lentiviral vectors for clinical development from phase I through phase III.

The new GMP facility will be used to handle human cells producing himeric antigen receptors (CARs) and T-cell receptor (TCR)-based cell therapies. 

The Theravectys has over 10 years of experience in lentiviral vector-based therapy and has successfully performed the first vaccination trial performed in humans with lentiviral vectors. (read more here from Yahoo News). 

Learn about "Lentiviral Vector-Based Therapy"

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).