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Prescription safety, FDA drug policy at forefront PDF Print E-mail
Written by Bryan Scribner   
Monday, 07 April 2008
Once again, prescription drugs are making headlines because they either carry the potential for dangerous side effects or are just plain ineffective.

The latest drug to fall into this category, Vytorin, failed to reduce the likelihood of heart disease in a clinical trial, according to a March 31 CBS/Associated Press story. Zetia, also for the treatment of high cholesterol, is a component of Vytorin.

The CBS story said drug makers waited for two years to release results of the study. Meanwhile, sales of the two drugs have added up to $5 billion.

A late March report in the Kansas City Star said the clinical trial showed the drugs might actually speed fatty plaque growth in arteries.

Late March and early April reports also mentioned other pharmaceuticals that have shown poor or dangerous results.

According to MSNBC:

  • Avandia, a diabetes drug, might increase heart attack risk;
  • Antidepressants might have no more of an affect than placebo;
  • And a drug used for breast cancer, Avastin, didn’t provide any benefit for overall survival.

The Washington Post reported:

  • Vioxx, a painkiller pulled off the market, increased the risk of heart attack and stroke;
  • Diabetes medication Rezulin was pulled because it caused liver problems;
  • And Baycol, for cholesterol, was withdrawn for causing muscle damage.

In addition, Novartis’ drug Zelnorm, for irritable bowel syndrome, in 2007 was linked to heart attack and stroke risk. The product is now available only to hospitalized patients or to those that have life-threatening illnesses, according to a Reuters story.

Drugs approved too quickly?
Research from Harvard, reported in the Washington Post story, indicates that drugs approved by the U.S. Food and Drug Administration right before deadline were four to fives times more likely to later be withdrawn or carry with them significant safety warnings. The on-deadline drugs were compared with drugs that more quickly reached FDA approval.

The FDA deadline for drug approval is 10 months, according to the Post.

Another story from CNN mentioned the use of Vytorin and Zetia significantly increased in the U.S. when they were featured in a $200 million advertising campaign. Sales were four times lower in Canada, where drug ads aren’t allowed.

According to a recent Consumer Reports poll, 87% of respondents were in support of legislation that would mandate FDA contact information be placed on televised drug ads. Two members of Congress on April 2 urged the FDA to put such a policy in place, according to an early April story in the Los Angeles Times.

Consumers not likely to report dangerous side effects
The Consumer Reports poll found that of the 16% of respondents who said a drug side effect sent them to a doctor or hospital, only 35% were aware they could report their experience to the FDA, according to the Times.

Congress passed legislation at the end of 2007 that requires FDA contact information in print ads.

For natural, safe and effective support, there are several enzyme-based nutritional supplements that could serve as alternatives to sometimes risky pharmaceuticals.

WellZymes™ Cardiovascular Health provides herbs, nutrients and enzymes for maintaining healthy blood levels of cholesterol and triglycerides. From your health care practitioner, be sure to ask about BioSET™ Vascular Maintenance,™ which is indicated for high blood levels of cholesterol and/or triglycerides.

E-mail Bryan Scribner at
Last Updated ( Monday, 07 April 2008 )
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