Buy this domain.
Drug Safety Experts Say FDA Allowing Dangerous Drugs on the Market | cialis online

Drug Safety Experts Say FDA Allowing Dangerous Drugs on the Market

AddThis Social Bookmark Button

Drug safety experts report that the U.S. Food & Drug Administration (FDA) is allowing dangerous drugs to find their way to market. The article was published, today, in the Journal of the American Medical Association.

The article blames the agency’s work to speed approval of new drugs to be what has allowed stroke prevention, cancer, and multiple sclerosis medications to be released without proper safety reviews, said The Wall Street Journal. The article, written by drug safety experts Thomas J. Moore and Curt D. Furberg, states that, in the agency’s zeal to approve medications, they might have mitigated prescription-drug safety. The pair pointed to a multiple sclerosis (MS) drug that has some significant cardiac side effects as well as numerous other risks, as well as Pradaxa, an anticoagulant linked to dangerous bleeding that can be “difficult to treat,” said The Journal.

“These examples raise the question of whether it was good policy to approve three innovative

new drugs with significant safety questions unanswered,” Mr. Moore and Dr. Furberg wrote. Moore is the author of two drug safety books and director of drug-safety publication, QuarterWatch, which provides independent evaluations of drug side effect data to the FDA. Co-author, Dr. Furberg, is emeritus professor of medicine at Wake Forest University and a clinical studies researcher, said The Journal.

The Journal pointed out that FDA Commissioner, Dr. Margaret A. Hamburg, has stressed the agency’s work to quicken approvals for innovative drugs, noting that the FDA approved 35 of these drugs in fiscal year 2011, alone. Only one time in the prior 10 years has the agency exceeded this number. And, noted The Journal, of the 35 drugs approved, 16 received some an expedited or shortened review or approval. The agency told The Journal that it could not provide comparable numbers for prior years’ accelerated approvals.

Janet Woodcock, director of the FDA’s center for drug evaluation and review, told The Journal that both the public and medical groups have sought quicker, not more cautious, approvals, saying, “I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks.” She added, “The cancer community in particular says we haven’t used accelerated approvals enough.”

The three drugs on which the authors concentrated are Caprelsa (vandetanib), an advanced thyroid cancer treatment; Gilenya (fingolimod), which is used to treat MS; and stroke prevention drug, Pradaxa (dabigatran etexilate), said The Journal. According to the authors, Caprelsa “was sufficiently toxic that overall survival” was “not different from that achieved with placebo,” citing company research. Caprelsa has been linked to serious abnormal heart rhythm and AstraZeneca Canada and Health Canada have advised Canadian healthcare providers about its safety, said NewsInferno. Patients have also reported rash, other skin reactions, diarrhea, increased blood pressure, and vision abnormalities.

The team also said company research on Gilenya, “disclosed seven major safety issues” including adverse cardiac effects. The drug received agency approval, but said that the drug will continue to be evaluated on 10 post-marketing studies. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told The Journal that the agency could find a better safety-innovation balance by urging drug makers to provide safety and efficacy data soon after drug approval and calling for drug withdrawal if data is not provided. “Once a drug is approved, it is often very difficult to put the genie back in the bottle,” he said. NewsInferno noted that U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), issued a warning against Gilenya use in heart patients, calling for extended early monitoring for patients diagnosed with significant bradycardia or heart block after the first dose. The announcement followed new FDA restrictions that followed reports of patient deaths.

Pradaxa, while offering some usage benefits over its predecessor, warfarin, can lead to dangerous bleeding that “may be more difficult to treat than warfarin-related bleeding,” said the team, noting that “no antidote is available for use in bleeding emergencies” linked to Pradaxa. Manufacturer Boehringer Ingelheim did not immediately respond to The Journal’s questions. Meanwhile, NewsInferno wrote that Pradaxa patients, involved in about one dozen lawsuits, are waiting to hear about a multidistrict litigation (MDL) concerning injuries they allege they suffered in association with the controversial blood thinner. The 12 lawsuits represent about half of what Boehringer and some other foreign corporations in the U.S., are facing. Pradaxa has been associated with about 260 fatal bleeds, worldwide, from March 2008 through October 2011, noted NewsInferno.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.