Navigation Links
FDA approves many drugs that predictably increase heart and stroke risk
Date:5/27/2014

The agency charged to protect patients from dangerous drug side effects needs to be far more vigilant when it comes to medications that affect blood pressure.

Robert P. Blankfield, MD, MS, a clinical professor of family medicine, issues this call to the U.S. Food and Drug Administration (FDA) in an editorial published recently in an online edition of the Journal of Cardiovascular Pharmacology and Therapeutics; the print version of the article is expected to appear this autumn.

The editorial notes that several medications survived FDA scrutiny, only to be pulled from the market after reports of increased heart attacks and strokes related to use of the drugs. These include rofecoxib (Vioxx), valdecoxib (Bextra), and sibutramine (Meridia). What these drugs have in common is that they raise blood pressure. Other medications approved by the FDA, including some antidepressant medications as well as medications used to treat attention deficit hyperactivity disorder, also raise blood pressure but remain on the market despite inadequate safety data.

At issue is the apparent disconnect between what patients and doctors might consider "clinically significant" risk and the standards that some FDA reviewers apply when evaluating the safety of new therapeutics. When it comes to medications that affect blood pressure, a few FDA reviewers only classify "clinically significant" blood pressure spikes as those that raise systolic blood pressure by 20 mm Hg (milliliters of mercury) or diastolic blood pressure by 10 to 15 mm Hg.

Increases in systolic blood pressure of more than 2 mm Hg or increases in diastolic blood pressure of more than 1 mm Hg raise the risk for heart attack by 10 percent and stroke by 7 percent in middle-aged adults, according to an epidemiological study published in Lancet in 2002. Younger individuals have less risk. For example, studies published in 2011 in the New England Journal of Medicine and the Journal of the American Medical Association indicate that attention deficit hyperactivity disorder medications are safe when used by young adults. While different populations differ in terms of cardiovascular risk, Blankfield believes one point should draw broad agreement: unless one is a healthy, young adult, clinicians and patients should have adequate cardiovascular safety data before they make prescription decisions.

"It is unwise to allow medications that predictably increase risk to be marketed without adequate safety data," said Blankfield, also a family physician at University Hospitals Berea Health Center. "Risk should be quantified, and the product label should accurately communicate the risk."

Blankfield, who has published other editorials recommending that the FDA require safety data for drugs that raise blood pressure, advocates a three-step solution. First, the FDA needs to establish specific guidelines regarding what degree of blood pressure elevation constitutes a risk for different populations (i.e. young adults, middle aged adults, older adults, diabetics, hypertensives, etc.). Then the agency should require pharmaceutical companies to provide cardiovascular safety data on medications that increase blood pressure. Finally, the agency should require pharmaceutical companies to post relevant data and/or warnings on medication labels.

"This would allow physicians and patients to make informed decisions about medications," he said. "Physicians and the general public may assume that if a drug is approved by the FDA, it is safe. Yet even modest elevations in blood pressure increase the risk of heart attacks and strokes."

Blankfield was moved to write this editorial now because of the public health importance of the issue.


'/>"/>
Contact: Jeannette Spalding
jeannette.spalding@case.edu
216-368-3004
Case Western Reserve University
Source:Eurekalert

Related medicine news :

1. FDA approves first targeted drug for advanced stomach cancer
2. Augusta Maine Chocoholic, Adam Green, Approves Xocai's "Change Your Chocolate" Success to Demand for Raw Blueberry in Nagoya, Japan and Taipei, Taiwan
3. German Research Foundation approves research unit to study extreme experiences in life
4. FDA Approves Memory Shape Silicone Implants
5. Branches' Ways to Work Program Approves 60th Car Loan
6. Breast Augmentation – FDA Approves New Silicone Gel Implant
7. AOAC International Approves ORAC as First Action Official Method
8. Texas House Approves Reverse Mortgage Legislation
9. FDA Approves New Drug to Fight Advanced Prostate Cancer
10. FDA Approves Morning-After Pill Without a Prescription
11. FDA Approves New “Gummy Bear” Breast Implants, But Albany Plastic Surgeon Urges Caution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... ... May 05, 2016 , ... Phycologia ... A (UV-A) for photosynthesis, researchers Juntian Xu and Kunshan Gao tested the magnitude ... pair observed that when photosynthetically active radiation (i.e. the white light in our ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... organization, announces McLaughlin & Smoak Benefits as the latest addition to its family ... has a dedicated team of compliance, wellness, human resources, and health care consumerism ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... compensation laws in all U.S. states and certain Canadian provinces is now available ... Workers Compensation Research Institute (WCRI). , The report, Workers’ Compensation Laws ...
(Date:5/5/2016)... ... ... A recent survey by the Midwest Business Group on Health ... use the free preventive care benefits available to them as part of the Affordable ... public and private employers, MBGH found that only 10% of large employers are aware ...
(Date:5/5/2016)... TX (PRWEB) , ... May 05, 2016 , ... Vitenas ... AIA/AAH Healthcare Design Awards, presented by the American Institute of Architects and the Academy ... designed by the renowned Perkins+Will and Harrell Architects, opened to patients in October of ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... 2016  As a teenager, an active and athletic ... damaged his heart. He continued enjoying sports and recreation ... Shepherd,s heart was giving out and he was a ... 2013, the Mesa, Arizona resident ... a heart transplant, the SynCardia TAH-t is the only ...
(Date:5/3/2016)... 3, 2016  While you may be familiar with watching a film or TV show in ... ultra-high-definition or 8MP in the Medical Industry.  Ampronix  is a renowned authorized reseller of the ... Photo - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
(Date:5/3/2016)... -- Pharmaceutical giant Johnson & Johnson has ... who says its talc-based powder products caused ovarian cancer. ... $5 million in compensatory damages and $50 million in ... ) , This is the second in ... the same court awarded $72 million to the family ...
Breaking Medicine Technology: