Zelnorm Recalled by FDA, Linked to Heart Problems and Stroke

At The Law Offices of Michael A. DeMayo, L.L.P., we work tirelessly to keep a pulse on the most recent news and information that may affect our clients. One area that we are particularly attentive to is the area of dangerous drugs. Most recently our focus has been on Zelnorm.

On March 30, 2007 the FDA issued an advisory informing the public that Novartis is complying with an FDA request to suspend marketing of Zelnorm. This request was made as a result of the drug being linked to an increased risk of heart attack, stroke and unstable angina.

Just a few days later, on April 2, 2007 the FDA took stronger action and removed Zelnorm from the market subsequent to analyzing the results of an extensive study of the drug's performance. The analysis included data gleaned from more than 18,000 patients, most of whom were treated with Zelnorm but some of whom received a placebo. The conclusion was that the benefits of the drug do not outweigh the risks. Those risks include serious cardiovascular adverse events such as heart attacks and strokes. Zelnorm has also been linked to severe cases of diarrhea, ischemic colitis and potentially death.

Zelnorm was initially marketed in the U.S. from August of 2002 through March 2004. During that period the FDA adverse reporting system did receive reports of patients who experienced serious adverse events. These reports included 21 that presented with serious consequences for diarrhea, 20 patients that were diagnosed with ischemic colitis and 3 patients diagnosed with other types of intestinal ischemia. In some patients, these adverse events have led to hospitalization, surgery and even death.

Since being approved by the FDA in 2002, Zelnorm, manufactured by Swiss drug maker Novartis AG, has been prescribed as a short term medication for women coping with irritable bowel syndrome. The primary symptom is constipation. The drug increases the movement of stools through the bowels. It does not cure irritable bowel syndrome but it has been shown to help the condition in some regards.

Zelnorm was marketed in 55 countries and was the first drug the FDA approved for the treatment of irritable bowel syndrome. Prior to being recalled it was under prescription to about 500,000 people and in 2006 alone the drug generated just under five hundred million dollars in revenues for the company.

The FDA made the following announcements in its Public Health Advisory:

· Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.

· Patients who are taking Zelnorm should seek immediate medical treatment if they experience any of the following symptoms: severe chest pain, shortness of breath, dizziness, any known symptoms of a heart attack or stroke.

· Physicians who prescribe Zelnorm should work with their patients to find appropriate alternative treatments.

If you or someone you know has been taking Zelnorm, we suggest that you follow up with your health care provider as soon as possible. If you or a loved one has suffered from the side effects of Zelnorm, contact the dangerous drug lawyers at the Law Offices of Michael A. DeMayo, L.L.P. to schedule your free initial consultation. You can visit our website at www.demayolaw.com or you can call us at 704-333-1000 or toll free at 877-333-1000.

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Drug Manufacturing Charges and Penalties

Drug manufacturing in Florida has become a primary focus for police efforts. Drug development, distribution, and sale are considered particularly problematic because of their suspected link to other criminal activity. Of all of the states, Florida is considered to have one of the highest levels of drug activity because of its long coastline that makes it an attractive destination for smuggling from overseas. Over the past few decades, Florida's drug laws have become more and more strict to attempt to reduce drug activity and drug related crimes in the state.

What is Drug Manufacturing?

Any activity involved in making a drug, from the raw chemicals or plant to the final production, is considered manufacturing. This includes cocaine manufacturing, meth labs, marijuana grow houses, and more. Just possessing the raw chemicals used to make a drug could result in a drug manufacturing arrest. Police typically discover manufacturing operations through tips or by investigating a suspicious looking building and its energy use. When police target a suspected facility, the typically confiscate any materials that are relevant to drug charges, including chemicals, plants, manufacturing equipment, weapons, and produced drugs. Any of these materials could be used as evidence in a manufacturing charge.

The New Law for Grow Houses

Recently Florida has targeted marijuana growing specifically with a new law entitled the Marijuana Grow House Eradication Act. This law puts tighter restrictions on what is considered a grow house. Prior to the new law, a grower must possess 300 plants or more to be charged with manufacturing. For fewer plants, the grower would be charged with a less severe drug possession charge. Under the new law however, an individual can be arrested for drug manufacturing for possessing just 25 plants.

Drug manufacturing is punishable as a second-degree felony under Florida law. If a child lives in the dwelling that is operating as a grow house, the charge is elevated to a first-degree felony. The law also specifies that it is now a third-degree felony in Florida to own a house used for growing and distributing marijuana.

Possible Penalties

Penalties for drug manufacturing in Florida vary widely. Drug manufacturing is typically prosecuted more aggressively than drug possession, because an individual possessing a drug isn't necessarily involved in the drug industry except as a user. A drug manufacturer, however, makes money off of making and selling an illegal substance that can reach many people. The severity of the punishment will vary depending on the type of drug, volume of the drug produced, and how involved the individual was in manufacturing. Typically in Florida, a drug manufacturing offense results in a minimum 3 year prison sentence and heavy fines.

For More Information

To learn more about drug manufacturing charges and penalties in Florida, please visit the website of experienced West Palm Beach criminal attorneys Eric N. Klein & Associates, P.A. today.

Joseph Devine

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God Busted By RCMP for Growing Pot 1 of 2 Jim Townsend

God busted by RCMP for growing pot is a discussion of who actually controls British Columbia's 24 billion dollar a year grow operations. During recent interdicts, the RCMP seize a couple million dollars worth of pot from small time operators who are in competition with them. A mere drop in the bucket to the proportion of the huge criminal enterprise that can not exist in our province without the help of an awful lot of Judges, Lawyers and Police Officers. If you think it is time to get the judiciary out of the drug business, please go to www.leap.cc and support Law Enforcement Against Prohibition. The largest industry in corporate CANADA is the corrections industry and it is the same in the US. The foreign owned British BAR Mitzvah Association has feathered its own nest comfortably as the coercive arm of the Global Banker owned corporations posing as de facto governments. Until we have lawful de jure governments and courts, we will be enslaved by these foreign criminals who blindfold Justice and slay innocents with her Divine Sword. I salute the good men with the pride, integrity and guts at LEAP to stand up against this criminal industry run by the courts.



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