Atlanta Personal Injury Lawyer - Drug Products

Zimulti And Suicidal Thoughts...A Link Has Been Shown According To Reports

M. Brandon Smith — Tue, 12 Jun 2007 00:03:19 GMT

According to recent reports, Zimulti, an obesity drug manufactured by Sanofi-Aventis SA has been linked to an increase in suicidal thoughts in its consumers. Although the drug is not currently being sold in the U.S, an FDA advisory panel is set to discuss Zimulti Wednesday to consider whether its approval should be granted in the states.

Known generically as rimonabant, the drug already is sold in 18 countries under the name Acomplia.
FDA statisticians said the incidence of suicidal thoughts and behavior "was higher for 20-milligram rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events, neurological adverse events and seizures were consistently higher for rimonabant."

Sanofi-Aventis on its website has maintained Zimulti's benefits far outweight its detrimental effects.

We will see if the FDA agrees on Wednesday...stay tuned!

Originally posted at InjuryBoard by M. Brandon Smith

Avandia And GlaxoSmithKline-More Controversy And Reported Threats To Patient Oriented Doctor

M. Brandon Smith — Wed, 06 Jun 2007 17:36:53 GMT

Issues surrounding GlaxoSmithKline's controversial diabetes drug Avandia continued today in a recent article published by ABCNEWS: Doctor to Testify in Avandia Hearing on Hill. According to reports, Dr. John Buse was contacted by SmithKline Beecham in 1999 after noting an increased trend of heart related problems in patients that were taking Avandia. Dr. Buse was reportedly threatened by the manufacturer with legal action for voicing his documented concerns and opinions due to a fear that his opinions would hurt the sales of Avandia and thereby potentially reduce their profits from the drug. Since that time Avandia has recently came under fire after the New England Journal of Medicine found that Avandia could raise patients' risk of heart attack by more than 40 percent.

Is this another example of Big Pharma putting profits over people? I have my thoughts on the issue but I would like for you to read the article and share yours in the comment section below.

Originally posted at InjuryBoard by M. Brandon Smith

Revised Black Box Warning For KETEK (Telithromycin)

M. Brandon Smith — Sun, 01 Apr 2007 09:20:37 GMT

KETEK (telithromycin), manufactured and sold by Sanofi-aventis U.S. recently decided, after prompting by the U.S. Food and Drug Administration, to include a revised black box warning and contraindication for myasthenia gravis patients. The new warning also removed the labels recommendation that KETEK be used in patients with chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).

For more information on the revised KETEK black box warning see the "Dear HealthCare Professional Letter":

Originally posted at InjuryBoard by M. Brandon Smith

Voluntary Recall Of Zelnorm Issued After Prompt By FDA

M. Brandon Smith — Sat, 31 Mar 2007 23:02:54 GMT

The sale of Zelnorm, (tegaserod maleate) approved in 2002 for treatment of irritable bowel syndrome with constipation, has recently been suspended by its manufacturer, Novartis, after the drug has been linked to a significant number of cardiovascular risks. This decision was made after the United State Food and Drug Administration found the drug can lead to increased occurrences of heart attack, stroke and serious chest pains. Doctor's with patients taking Zelnorm are being asked by the FDA to work with their patients to find other suitable replacement medications and therapies.

Earlier this year, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.
The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

Originally posted at InjuryBoard by M. Brandon Smith

Nationwide Recall Of Permax (Pergolide) Issued

M. Brandon Smith — Fri, 30 Mar 2007 14:48:39 GMT

The United States Food and Drug Administration has issued a public health announcement concerning the withdrawal of Permax (Pergolide) from the market due to a link of increased heart valve damage in its consumers. The advisory indicates two new studies showed patient's with Parkinson' Disease, who ingested pergolide, were at a higher risk of developing cardiovascular problems than those who did not take pergolide. Pergolide is commonly used to manage the symptoms of Parkinson's Disease and is a member of the dopamine agonists drug class. Anyone with Permax (Pergolide) is directed to stop taking the drug immediately in order to prevent any further injury.

According to the FDA:

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem. Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.
In light of this additional safety information and the availability of alternative treatments for Parkinson's disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution and will, in cooperation with FDA, work to remove from the market both the name brand Permax (pergolide) and the generic versions of pergolide. The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for healthcare professionals and patients to discuss appropriate treatment options and to change treatments.

Originally posted at InjuryBoard by M. Brandon Smith

Defense Verdict In Madison County Vioxx Trial

M. Brandon Smith — Tue, 27 Mar 2007 21:57:17 GMT

In the latest Vioxx trial, a Madison County jury found in favor of Merck & Co. after deliberating for more than 6 hours over the course of two days. The jury members rejected Patty Schwaller widower's claim that Merck & Co. was to blame for his wife's sudden death linked to cardiovascular side effects.

In siding with Merck, the jury concluded that Vioxx was not a "proximate cause" in the death of Patty Schwaller, who had taken the drug for about 20 months before suddenly collapsing and dying in her Granite City home.
Merck, which pulled Vioxx off the market in 2004 after its research showed it increased the risk of heart attacks and strokes, celebrated its 10th victory in 15 cases that have been tried in the mushrooming litigation over Vioxx. It was the first trial in the Midwest and had been conducted in a county known for large awards favoring plaintiffs.
Merck isn't out of the woods. The company, based in Whitehouse Station, N.J., has been deluged with more than 27,000 personal injury lawsuits and another 265 potential class-action lawsuits alleging harm from Vioxx. The company has reserved $1.64 billion in its Vioxx legal defense fund and said again Tuesday it plans to fight each lawsuit.

Attorneys for the plaintiff's estate are planning an immediate appeal to contest not on the way the trial was conducted but also to contest various other legal matters that are believed to have been reversible errors. This defense verdict is in stark contrast to a Plaintiff's verdict of $47.5 million earlier this month against Vioxx and it manufacturer Merck & Co. wherein it was said Merck & Co. failed to warn of the cardiovascular risks and dangers associated with Vioxx.

Originally posted at InjuryBoard by M. Brandon Smith

Will RotaTeq Be Linked To New Intussusception Cases?

M. Brandon Smith — Sat, 24 Mar 2007 01:23:19 GMT

RotaTeq, a vaccine manufactured by Merck & Co., that received FDA approval in February of 2006, is currently being investigated for a connection to a condition called intussusception. Intussusception is a very serious and life threatening condition that causes the intestines to twist and form blockages. It is a fairly rare condition, but more than 28 cases have been reported lately in various infants throughout the United States. Since its approval, over 3 million doses have shipped and/or utilized worldwide. The FDA recalled the first intussusception prevention drug some eight years ago due to serious side effects it caused in hundreds of infants. Although no studies have definitely shown a link between RotaTeq to intussusception thus far, numerous studies and projects are being conducted on the new drug. If you have a baby that was given RotaTeq and developed intussusception, please contact one of our personal injury attorneys immediately to further discuss your potential case free of charge.

Originally posted at InjuryBoard by M. Brandon Smith

Plaintiff's Finish Their Case In Midwest Vioxx Trial

M. Brandon Smith — Sun, 18 Mar 2007 16:20:29 GMT

The Plaintiff's side of the case has been concluded in Madison County where the family of Patricia Schwaller has alleged that Vioxx contributed to and caused the 52-year-olds death. It was shown in the Plaintiff's case in chief that Schwaller, who died in 2003, did not have a history of heart attacks, strokes or other symptoms of congestive heart disease prior to her use of Merck & Co.'s Vioxx. Schwaller suddenly collapsed and died according to her family after using the controversial drug Vioxx for more than 20 months prior.

The defense team for Merck & Co. is expected to put their spin on the case by alleging Schwaller's high blood pressure, obesity and diabetes really contributed to her sudden passing. The jury is expected to get the opportunity to decide the case next week and will be asked to determine if Merck & Co. adequately warned about the potential risks associated with Vioxx's use.

Last week a New Jersey jury found Merck & Co. did not properly warn Frederick "Mike" Humeston who suffered a heart attack in 2001 after his use of Vioxx. That Vioxx Trial resulted in a $47.5 verdict against Merck & Co. with $27.5 million of that amount being awarded as punitive (or punishment) damages.

Originally posted at InjuryBoard by M. Brandon Smith

Sleeping Aids Maybe More Dangerous Than Originally Thought

M. Brandon Smith — Sat, 17 Mar 2007 10:52:50 GMT

If you currently take Ambien,Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and/or Sonata you ought to be aware of a recent concern issued by the U.S. Food and Drug Administration relating to their use in connection with some very serious side effects. The drugs listed above are commonly prescribed to millions of consumers to address sleeping disorders and often promise a restful nights sleep. According to the FDA, these drugs are causing people to do more than get a good nights sleep-it is also causing them to suffer severe allergic reactions as well as undertake unique sleep-related behaviors such as "sleep driving."

Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

These behaviors and side effects prompted the FDA in December of 2006 to request all the above drugs to include stronger warnings about these issues so as to help limit this unwanted effects. According to the letters sent to the manufactures by the FDA, the following information should be contained in their revised warnings so as to alert the public to these potentially deadly side effects and risks:

â€¢ Anaphylaxis (severe allergic reaction) and angio edema (severe facial swelling), which can occur as early as the first time the product is taken.
â€¢ Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.
Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

This information is very important news for the millions of Americans who use these products on a daily basis. There have already been numerous reports of people reportedly sleep driving and subsequently causing serious auto accidents without the faintest memory of the event after it occurs. Anything that promotes more public awareness to such potential deadly effects is a great idea given the alternative here. The more one knows in taking these medications, the better apt they are to prevent such problems from occurring in the future and that will make everyone a little more safer as a result.

Originally posted at InjuryBoard by M. Brandon Smith

$47.5 Million Vioxx Verdict After Idaho Man Suffers Heart Attack

M. Brandon Smith — Mon, 12 Mar 2007 18:24:47 GMT

An Atlantic City jury returned a plaintiff's verdict today against Merck & Co. to the tune of $47.5 million after its arthritis drug Vioxx lead to an Idaho postal worker's heart attack. $20 of the $47.5 million was awarded for compensatory damages and the remaining $27.5 million was awarded as punitive damages in order to punish Merck & Co. for their failure to warn about the cardiovascular risks associated with the use of Vioxx. This marks the second Vioxx trial Frederick "Mike" Humeston has been involved in after a judge granted a new trial in his first trial when new evidence was discovered showing serious risks and complications after only short term use of Vioxx.

Humeston lost his first trial against the pharmaceutical giant in 2005, but New Jersey Superior Court Judge Carol Higbee granted him a second trial because new evidence surfaced that short-term Vioxx use could also be risky; Humeston took the drug on and off for about two months.

The five-man, three-woman jury ruled on March 2 that Merck was negligent and did not provide adequate warning about those risks before Humeston's heart attack. That set the stage for a second phase of the trial, with the jury last week hearing evidence on whether Vioxx contributed to Humeston's heart attack, entitling him to damages.

Then, after brief arguments over punitive damages, the jury deliberated briefly late Monday and decided to assess $27.5 million in punitive damages against Merck.

Originally posted at InjuryBoard by M. Brandon Smith