Miami Personal Injury Lawyer - FDA & Prescription Drugs

Vioxx Settlement Reveals Need for Drug Industry Reform

Seth Miles — Tue, 27 Nov 2007 11:26:56 GMT

This morning I ran across an editorial about the recent Vioxx settlement that did a great job pointing out the need for reform in the pharmaceutical industry as well as specific areas where reform is needed. Merck announced a few weeks ago that it would settle Vioxx lawsuits for $4.8 billion.

The list of necessary reforms is long.
The Prescription Drug User Fee Act passed by Congress in 1992 needs to be revisited. The act charged drug companies a "user fee" for every drug approved. That money goes to the U.S. Food and Drug Administration to be used to speed up the approval process.
In other words, drug companies now pay the FDA to approve drugs more quickly. The proportion of FDA's budget provided by such fees has increased dramatically since the act passed, and there's been a corresponding decrease in resources devoted to tracking the safety record of drugs that have already won approval.
More must be done to guard against conflicts of interest. Earlier this year, the FDA approved new rules restricting the participation on safety panels of expert advisers with financial ties to drug makers. While the rules are an improvement over the current system, they need further tightening.

Vioxx was rushed through the approval process, marketed heavily and prescribed to people who did not need it - meaning they had no stomach issues with other pain relievers. And some reports estimate as many as 50,000 people died.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Seth Miles

Zelnorm Recall

Staff Writer — Sat, 31 Mar 2007 17:55:34 GMT

The popular drug used to treat irritable bowel syndrome, Zelnorm, was pulled from the market Friday by Novartis, the drug's manufacturer. Zelnorm has been linked to an increased risk of heart attack and stroke, and the FDA recommended Novartis recall the drug.

It was the second drug recall in two days. Pergolide, a Parkinson's medicine originally sold by Eli Lilly as Permax and now in generic form, was withdrawn Thursday be cause of links to heart valve problems.
Zelnorm was approved in 2002 for short-term treatment of women who suffer from irritable bowel syndrome with constipation, and in 2004 for men and women younger than 65 with chronic constipation. In 2004, a new warning label was added about side effects including diarrhea and colitis.
The FDA said doctors who prescribe Zelnorm should work with their patients and transition them to other therapies. An estimated 12 million Americans suffer from the painful and disruptive symptoms of irritable bowel syndrome with constipation.

Zelnorm had about $500 million in sales in 2006.

Originally posted at InjuryBoard by Staff Writer

More Dangerous Diet Drugs in Miami?

Staff Writer — Fri, 13 Jan 2006 21:11:17 GMT

The FDA warned of two more drugs being sold primarily on the Internet, Brazilian herbal supplements containing controlled substances that could cause "serious injury or side effects." The two dangerous supplements are called Herbathin and Emagrace Slim. Both manufactured by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim.

In the FDA warning, the FDA said that dieters should avoid these supplements which contain ingredients sold in prescription drugs. These drugs, like many before them, can be harmful to your health and you should consult with your doctor before taking dietary supplements just as you would with prescription diet pills. They can be just as dangerous, especially if you have health complications.

According to the FDA:

Emagrece Sim and Herbathin are labeled as "dietary supplements", but they contain prescription drugs, including several controlled substances that, if not used properly as prescribed by a physician, can be harmful. They contain chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. It may be habit forming, and can cause drowsiness and dizziness and impair the ability to drive. Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder, and bulimia. It has been linked to several serious drug interactions and certain serious adverse events, including suicidal thinking and behaviors in pediatric patients, anxiety and insomnia, and abnormal bleeding. These drugs should only be taken by patients who are under the supervision of a health care provider.

These drugs may cause you to test positive for amphetamines and are distributed by Emagrece Sim Laboratories, Inc., Miami, FL., and Herbathin, Inc. (dba EMIEX Corp), Miami, Florida.

Originally posted at InjuryBoard by Staff Writer

Warning Issued for Birth-Control Patch

Staff Writer — Fri, 11 Nov 2005 10:03:19 GMT

FDA is warning users of the popular Ortho Evra birth control patch that they are being exposed to more hormones, and are therefore at a higher risk of blood clots and other serious side effects. Consumer groups and some obstetricians are recommending patients stop using the patch and get new forms of birth control. Attorneys have already fimed many Ortho Evra lawsuit, and those same lawyers say to expect many more.

See the Louisville Courier-Journal for more details on theOrtho Evra warning and lawsuits.

Originally posted at InjuryBoard by Staff Writer