Archive for October, 2008

Reports of serious drug reactions hit record

Friday, October 24th, 2008

The Associated Press is reporting the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year, setting a record.

According to the report, the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including reports of more than 4,800 deaths.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug’s problems were prompted by tainted heparin imported from China.

The other was Chantix, a new kind of anti-smoking drug from Pfizer.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said contaminated heparin was largely to blame.

New Avandia suit filed in Texarkana

Wednesday, October 22nd, 2008

A Northeast Texas man has filed a personal injury suit against Smithkline Beecham Corp., doing business as GlaxoSmithKline, claiming Avandia cause a series of heart attacks.

After being diagnosed with type 2 diabetes in May of 2000, the man took Avandia for seven years as a way to improve control of his blood sugar levels. Now he believes the drug caused him to have heart attacks in 2003 and in 2006.

The suit claims that GlaxoSmithKline did know or should have known that Avandia can cause “heart injury, excessive fluid retention, fluid-overload disease, congestive heart failure, heart attack, liver damage, liver failure, and severe injury to the heart leading to cardiac arrest or death.”

As a result of several studies, in May 2007, the FDA issued a safety alert advising patients that there is a potentially significant risk of heart attacks and heart-related deaths. In November 2007, GlaxoSmithKline gave the drug a black box warning.

The suit alleges GlaxoSmithKline negligently allowed the public disclosure of positive information, but withheld or concealed negative information about Avandia’s safety and effectiveness.

If you have experienced adverse effects from taking Avandia or any other defective drug, you should seek the advice of a skilled, defective drugs attorney and determine if you are due any compensation for your injuries.

Congress, FDA tussle over contaminated heparin supplier

Wednesday, October 22nd, 2008

The FDA and Congressional investigators are fighting over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.

Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery.

Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States.

The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.

The FDA claims that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.

Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.

Baxter, the country’s major manufacturer of the drug, has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.

One of the plants that the FDA has inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world’s major supplier of heparin’s active ingredient.

At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug.