Connecticut Personal Injury Blog - FDA & Prescription Drugs

Trasylol Pulled from Market

Shannon Weidemann — Sun, 11 Nov 2007 16:25:15 GMT

An antibleeding drug used during heart surgery has been pulled from the market amidst concerns it may harm more than it helps. Bayer is the maker of recalled Trasylol. The drug may be responsible for a higher risk of kidney failure, heart attack and stroke.

Trasylol is supposed to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions. The FDA and regulators in Germany and Canada said they are concerned by a clinical study that was suspended by a safety-monitoring board after early results suggested Trasylol might be linked to a 50% higher risk of death than competing drugs. FDA officials on a conference call yesterday said they couldn't identify a group of patients for whom the drug's benefits would outweigh its apparent risk.

Trasylol has been used since 1993 by 4.8 million patients. Some lawsuits have already been filed against Bayer before the recall was announced.

If you would like to learn more about defective drugs, please visit InjuryBoard's Prescription Drugs information page.

Originally posted at InjuryBoard by Shannon Weidemann

Vioxx Lawsuit Settled for $4.8 Billion

Shannon Weidemann — Sun, 11 Nov 2007 15:11:05 GMT

The pain reliever Vioxx has been linked to a greater risk of heart attack and stroke in patients that have taken the drug. A number of lawsuits were filed against the drug manufacturer Merck. The company this week agreed to settle the cases with $4.8 Billion to be split by those affected.

The company reached an agreement with lawyers representing many of the 47,000 plaintiffs with claims early this morning, after extensive negotiations. The settlement could lead to payments for tens of thousands of Vioxx users who can prove they suffered a heart attack or stroke -- and who have filed a claim by Nov. 8, 2007.

All of the parties involved in the lawsuits will need to agree to the terms of the settlement. Vioxx was pulled from the market in September of 2004.

If you would like to read morea bout Vioxx, please visit InjuryBoard's Prescription Drug information page.

Originally posted at InjuryBoard by Shannon Weidemann

J&J'S Damage Control Over Birth Control Patch

James Sabatini — Sun, 06 May 2007 22:34:52 GMT

The maker of the widely used Ortho Evra birth control patch, Johnson & Johnson, is trying to prevent negative attention over its dangerous contraceptive by purchasing the rights to domain names like Orthoevrakills.com and Deathbypatch.com.

In late 2005 when the Food and Drug Administration urged that a heightened warning alerting users to the risk of potentially fatal blood clot and stroke be added to the drug's label. In February 2006, a study showed that women using the Ortho Evra birth control patch faced double the risk of blood clots than women who use oral contraceptives. The increased risk is due to the fact that the patch exposes users to higher levels of hormones--60 percent more--than oral medications.

Johnson & Johnson purchased and registered the domain names but is not using them. The move was strictly an attempt to preempt critics of Ortho Evra from attracting negative attention to the dangerous drug.

Originally posted at InjuryBoard by James Sabatini

Valeant Withdraws Permax

James Sabatini — Sat, 31 Mar 2007 12:52:07 GMT

The FDA announced that the maker of the Parkinson's disease drug Permax was voluntarily withdrawing the medication because of the risk of serious damage to patients' heart valves. Permax increases the chance of regurgitation of the tricuspid, mitral and aortic valves of the heart.

Originally posted at InjuryBoard by James Sabatini

Zelnorm Pulled From Market

James Sabatini — Fri, 30 Mar 2007 13:28:45 GMT

Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack, U.S. government health officials said Friday. Novartis agreed to withdraw Zelnorm at the FDA's request

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Originally posted at InjuryBoard by James Sabatini

Protopic & Elidel Linked to Cancer?

James Sabatini — Wed, 28 Feb 2007 14:26:00 GMT

Last January the FDA issued a block box warning for the topical ointments Protopic and Elidel. The warning was issued due to long-term use of the drugs possibly being linked to cancer.

Originally posted at InjuryBoard by James Sabatini

Ortho Evra Patch Causing Injuries and Death

James Sabatini — Mon, 26 Feb 2007 21:19:38 GMT

A personal injury lawsuit has been filed in Santa Clara County Court against a Mountain View company and others involved in developing the Ortho Evra patch, a widely used contraceptive that has been the source of thousands of adverse reaction complaints around the country.
The latest lawsuit names 46 plaintiffs -- the majority of them young women in their teens and 20s -- who suffered blood clots, stroke and death. In one case, a 23-year-old woman suffered a deep vein thrombosis and died after wearing the patch one month.

Originally posted at InjuryBoard by James Sabatini

BAYER FAILED TO REVEAL TRASYLOL RISK STUDY

James Sabatini — Sat, 30 Sep 2006 22:11:46 GMT

The F.D.A. announced that Bayer A.G., failed to reveal to federal drug officials the results of a large study suggesting that Trasylol might increase the risks of death and stroke. The F.D.A. recently announced that Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

The F.D.A. only found out about the Trasylol study after getting a tip from a researcher involved in the study. Bayer's eplanation for not disclosing the study and its results - it mistakenly failed to inform the F.D.A. Certain FDA officials were shocked that Bayer neglected to inform them of the study. This recent study is another piece of evidence pointing to serious dangers and risks with taking Trasylol. In January, an article published in the New England Journal of Medicine, found that Trasylol increased the risks of kidney failure, stroke and heart attack. The article's author opined that stopping the drug's use would prevent 10,000 to 11,000 kidney failures per year.

Originally posted at InjuryBoard by James Sabatini

AP Investigation of Ortho Evra Birth Control Patch

James Sabatini — Wed, 27 Sep 2006 22:31:13 GMT

An investigation by the Associated Press revealed birth control patch users die and suffer blood clots at a rate three times higher than women taking the pill. It is believe that this serious increase risk is connected to the fact that the birth control patch delivers about 60% more estrogen than the pill.

Originally posted at InjuryBoard by James Sabatini

Study Cites Increased Death Risk From Asthma Drugs

James Sabatini — Mon, 12 Jun 2006 17:10:06 GMT

Accoring to a new analysis of 19 studies, popular asthma medicines such as Advair and Serevent pose a substantially increased risk of hospitalization and death to users compared with placebos. This new analysis raises the possibility that the drug should be taken off the market if it continues to be so widely used.

The Washington Post quoted the lead author of the new analysis, Shelley Salpeter of Stanford University:

What we have here is a drug that increases the number of people who will die from the disease it is treating. The long-acting bronchodilators can help reduce symptoms for many people, but we think the price in terms of serious side effects and deaths is unacceptable.

The use of long-acting bronchodilators can be associated with a clinically significant number of internsive care admissions and deaths each year. In this new anaylsis, the authors estimate that Advair may be responsbile for as many as 4,000 to 5,000 asthma-related deaths each year in the United States.

Originally posted at InjuryBoard by James Sabatini