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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: