FDA & Prescription Drugs | InjuryBoard Atlanta

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...

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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...

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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...

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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....

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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...

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Do you or a loved one use an anemia drug? If so, you ought to be aware of a recent U.S. Food and Drug Administration warning associated with the use of prescription anemia drugs that can cause an increased risk of death or other serious side effects linked to cancer or kidney disease. The drugs, commonly sold as Procrit, Epogen and Aranesp, are designed to increase red blood cell counts and...

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The mandate of a black box warning by the U.S. Food and Drug Administration concerning many antidepressant medications over the last few years has sparked a debate among many scholars as to whether the mandate has caused an increase in teenage suicide. The warning, which informed doctors of a potential risk of increased suicidal thoughts among its users, was ordered by the FDA in 2004 on...

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The U.S. Food and Drug Administration announced last Friday that it no longer intends to publish a public list of potentially dangerous prescription drugs that was going to warn the consuming public of potential safety concerns and risks. The idea was discussed and proposed by the FDA after the withdrawal of Merck & Co.'s arthritis drug Vioxx in 2004. Instead now the FDA has decided it will only...

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The U.S. Food and Drug Administration panel has set out to review Arcoxia, Merck & Co. Inc.'s replacement pain reliever drug for Vioxx which was recalled back in 2004. In a meeting set for April 12, 2007, the panel expects to discuss the safety and effectiveness of Arcoxia which is being heavily pushed by Merck for FDA approval. Of note worthy concern, Arcoxia, like Vioxx and Bextra, is a cox-2...

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In the latest New Jersey Vioxx trial, the jurors rendered a verdict in favor of the plaintiff, Frederick "Mike" Humeston, who took Vioxx prior to his death. In this bifurcated preceding designed only to address Merck's potential liability, the New Jersey state court jury found that Merck & Company failed to warn about the dangers associated with Vioxx in causing cardiovascular risks and...

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Jury selection for the latest Vioxx trial is under way for a man whose wife is said to have died as a result of taking Vioxx. Frank Schwaller says his wife, then 52 and now deceased, took the painkiller manufactured by Merck & Company for an extended period to combat her pains and ailments. The attorney for Schwaller asked the prospective juror members a number of questions to determine if they...

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Prempro lawsuit leads to a $3 million verdict against its manufacturer Wyeth after causing an Ohio woman's breast cancer. The Philadelphia Court of Common Pleas jury found that Wyeth ``failed to provide an adequate warning'' to the plaintiff given the known side effects of it use. This was the fifth trial against Wyeth and marks the largest jury verdict thus far. Three of the other trials...

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On January 25, 2007 a products liability lawsuit was filed on behalf of Mrs. Ada M. Williams against Bayer Corporation and Bayer AG after receiving their drug Trasylol during her open-heart surgery. According to the Trasylol lawsuit, Ms. Williams subsequently went into kidney failure and now has to undergo kidney dialysis three times a week due to complications caused by the drug. Ms. Williams'...

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The Food and Drug Administration has said that the manufacturer of Trasylol (aprotinin) needs to use a stronger warning associated with the drug to address the overwhelming number of risks associated with kidney damage. Bayer is being asked by the FDA to promote the use of Trasylol, a drug which is used to help reduce blood loss during coronary artery bypass surgeries, only in patients who are...

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In a recent opinion from the American College of Obstetricians and Gynecologists, pregnant women are being told to not take the antidepressant Paxil because of the increased risk of birth defects in a fetus. This group's view comports with the same findings the FDA noted earlier this year when two other studies showed that Paxil almost doubled the chance of developing heart defects in infants...

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