FDA is Criticized over Dangerous Drugs

In the United States dangerous drugs are regulated by the U.S. Food and Drug Administration – not rigorously enough, according to some of the FDA’s fiercest critics.

In 2005 the FDA came under fire from Dr. David Graham. His words carried extra weight because he was an insider – a senior scientist within the FDA’s own office of drug safety, CBS news reported.

See this alert over the dangers of Actos.

Graham said the FDA was allowing dangerous drugs to stay on the market, and had failed to withdraw a drug he said contributed to the injuries and deaths of thousands of Americans.

“I know that FDA is responsible for 100,000 people being injured. And FDA wants to keep that swept under the rug nice and quiet,” Graham told the channel.

His concern was over the painkiller Vioxx which the FDA left out there on the market for five years — apparently disregarding a mounting body of evidence that it increased the risk of heart attacks and strokes.

Vioxx may have been a high profile case but there are many others. Seldom week goes by when there isn’t a recall of a drug in America because of its dangerous side effects.

The latest drug to be pulled is the natural male enhancement drug RegenErect, a drug available in communities well before its maker Regeneca, Inc. announced a voluntary recall.

In a recent press release, the U.S. Food and Drug Administration said the company, found the presence of Tadalafil, meaning these products were unapproved new drugs.

Although Tadalafil is an FDA-approved drug used as treatment for male erectile dysfunction, the active ingredient is not listed on the label of RegenErect. People who take it may not be aware of the risky side effects until it’s too late.

“Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance,” the FDA said in its press release.

These kinds of recalls are common in the world of prescribed drugs. RegenErect is the latest in a series of products found to be linked to harmful side effects. In some cases these drugs have been out on the market long enough for serious damage to be done to those who take them.

In 2011 the FDA announced the diabetes drug Actos exposes patients to an increased risk of bladder cancer.

Use of Actos, also known as pioglitazone, was suspended in France and new prescriptions were banned in Germany.

In the US the warning was based on FDA’s review of data from a five-year interim analysis of an ongoing, 10-year epidemiological study. The lawsuits have been coming in ever since last year’s warning.

The FDA’s critics say it takes too long for the agency to respond to the warning signs. Patients were developing bladder cancer while the regulator pursued its five year study on Actos.

Other dangerous drugs to go out on the market in recent years include:

  • Yaz, Yasmin, and Ocella birth control pills. The pills have been linked to an increased risk of gallstones, blood clots, depression, stoke and breast lumps. The pills have even been linked to the deaths of women.
  • Paxil, a popular antidepressant, approved by the FDA almost 20 years ago, was hailed as a wonder drug to treat depression. It has exacerbated these problems in some patients, leading to depression, problems sleeping and suicidal feelings. Paxil has been linked to some suicides and killings.
  • Avandia, another diabetes drug, has been linked to chest pains, vision problems, headaches, brittle bones and respiratory infections. Alarmingly, this drug is linked to an increased risk of heart attacks, with some studies suggesting it increases the risk of patients suffering a heart attack by 30 to 40 percent, compared to other diabetes medications.

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