Dallas Personal Injury Lawyer Blog

FDA Revokes Use of Avastin For Breast Cancer Due to Danger of Injury - Dallas, Texas

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

Dr. Margaret A. Hamburg, the commissioner of the Food and Drug Administration, said that the drug was not helping breast cancer patients to live longer or control their tumors.

The commissioner, Dr. Margaret A. Hamburg, said that the drug was not helping breast cancer patients to live longer or control their tumors, but did expose them to potentially serious side effects such as severe high blood pressure and hemorrhaging.

“This was a difficult decision,” Dr. Hamburg, said in a statement.  The F.D.A. “recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use.

“After reviewing the available studies,” she continued, “it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will help them live longer or improve their quality of life.”

If you have a claim regarding Avastin, please call 214-855-0034 or jonathan@theleblanclawfirm.com or www.injurylawyerdallastexas.com

GlaxoSmithKline To Pay 750 Million For Bad Products - Dallas, Texas

 

GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.

In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care.

Using claims from industry insiders, federal prosecutors are not only demanding record fines but are hinting at more severe actions.

Suffering a research drought, drug makers have laid off thousands of employees. Some of those dispatched have in turn filed whistle-blower lawsuits that can lead to criminal investigations.

Justice Department officials announced the settlement in a news conference Tuesday afternoon in Boston, saying a $150 million payment to settle criminal charges was the largest such payment ever by a manufacturer of adulterated drugs. The outcome also provides $600 million in civil penalties. The share to the whistle-blower will be $96 million, one of the highest such awards in a health care fraud case.

For more information regarding bad drugs, go to www.injurylawyerdallastexas.com or call 214-855-0034.

 

FDA To Limit Avandia Due To Risk of Injury To Heart - Dallas, Texas

 

The Food and Drug Administration said Thursday that it will sharply limit access to the anti- diabetes drug Avandia because of concerns about an increased cardiovascular risk associated with the drug.  Patients who are now taking the drug will have to sign an informed consent statement acknowledging that they understand all the risks before they will be allowed to continue refilling prescriptions. New patients will not be able to receive the drug unless their doctor certifies that they are unable to control their blood sugar levels with other medications and that they are unable to take Avandia's primary competitor, Actos, for medical reasons.
 

The agency said it is also calling a halt to a major study, called TIDE, that directly compares the efficacy of Avandia and Actos in controlling blood sugar.

At the same time, the European Medicines Agency said that it will suspend marketing of Avandia, also known by the generic name rosiglitazone, throughout the European Union.

"In our view, there is substantial alignment between the agencies on the interpretation and the risk to health," Dr. Margaret A. Hamburg, FDA commissioner, said at a news conference. The agencies have been in close consultation, she added, and the difference in their approaches reflects the tools they have available to handle the drug.

In both cases, the new rules will not take effect for several months.

In the United States, about 600,000 people are currently receiving Avandia. "We think the number will go down very, very significantly with these new requirements," Hamburg said.

The new rules will also apply to combination drugs containing rosiglitazone, including Avandamet, which contains metformin, and Avandaryl, which contains glimepiride.

Avandia was hailed as a major improvement in diabetes control when it was first introduced, and many patients are unable to obtain adequate suppression of glucose levels without it. In 2006, at least 1 million American Type 2 diabetics were taking it. But a meta-analysis published that year suggested that there was as much as a 40% increase in risk of cardiovascular disease, heart attack, stroke and death among users.

In 2007, the FDA put a so-called black box warning on the drug's label alerting consumers to the risk, and sales began falling. Two separate FDA advisory committee meetings since then, the latest a heated meeting in July, have produced mixed results, with some experts arguing for stronger warning labels on Avandia and others arguing for its immediate withdrawal.

The new rules represent, in effect, a delaying action until the FDA can obtain better information about the risks. The agency said it will require Avandia's manufacturer, GlaxoSmithKline, to commission an independent review of a major trial called RECORD that may shed some light on the risks.

Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said that "patients should continue taking the medication and consult their healthcare provider. It's very important that patients continue to control their blood sugar."

For more information about Avanida, call 214-855-0034 or go to www.injurylawyerdallastexas.com

 

Pfizer To Withdraw Cancer Drug Mylotarg Due To Patient Wrongful Deaths

 

Pfizer To Withdraw Cancer Drug Mylotarg

Pfizer will withdraw cancer drug Mylotarg amidst concerns that the drug is ineffective and may actually decrease lifespan when compared to traditional chemotherapy, the Associated Press reports.

Although the study was intended to show that adding Mylotarg to chemotherapy increased lifespan, it indicated that Mylotarg failed to slow relapsed acute myeloid leukemia, the bone marrow cancer it was prescribed to treat. About 2,500 patients in the U.S. are treated with the product annually. Pfizer will withdraw the drug effective Oct. 15, 2010.

Mylotarg was granted an accelerated approval by the FDA in 2000 but it appears that the drug can’t live up to the early promise it had one shown. A follow-up study halted last August reported more deaths amongst patients taking Mylotarg plus chemotherapy than those undergoing chemotherapy alone.

Drug manufacturers owe many duties to the users of their products. Specifically, they have a duty to not design or manufacture unreasonably dangerous drugs. Furthermore, they have a duty to warn users of the dangers of their medicines so individuals can make informed decisions. Although Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease, the FDA has stated that reports of the disease associated with the drug increased during its time on the market.

As more facts develop, Pfizer could face civil liability if they violated those duties by failing to accurately warn users of potential dangers their products posed. If you or someone you know has been injured by a dangerous drug you should consider speaking to an attorney with experience in these matters. They can provide valuable counsel as well as preserve evidence and protect your rights.

The drug will no longer be available to new patients.

For more information on dangerous drugs in Dallas, Texas go to www.injurylawyerdallastexas.com or call 214-855-0034.

Pfizer will withdraw cancer drug Mylotarg amidst concerns that the drug is ineffective and may actually decrease lifespan when compared to traditional chemotherapy, the Associated Press reports.

Although the study was intended to show that adding Mylotarg to chemotherapy increased lifespan, it indicated that Mylotarg failed to slow relapsed acute myeloid leukemia, the bone marrow cancer it was prescribed to treat. About 2,500 patients in the U.S. are treated with the product annually. Pfizer will withdraw the drug effective Oct. 15, 2010.

Mylotarg was granted an accelerated approval by the FDA in 2000 but it appears that the drug can’t live up to the early promise it had one shown. A follow-up study halted last August reported more deaths amongst patients taking Mylotarg plus chemotherapy than those undergoing chemotherapy alone.

Drug manufacturers owe many duties to the users of their products. Specifically, they have a duty to not design or manufacture unreasonably dangerous drugs. Furthermore, they have a duty to warn users of the dangers of their medicines so individuals can make informed decisions. Although Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease, the FDA has stated that reports of the disease associated with the drug increased during its time on the market.

As more facts develop, Pfizer could face civil liability if they violated those duties by failing to accurately warn users of potential dangers their products posed. If you or someone you know has been injured by a dangerous drug you should consider speaking to an attorney with experience in these matters. They can provide valuable counsel as well as preserve evidence and protect your rights.

The drug will no longer be available to new patients.

For more information on dangerous drugs in Dallas, Texas go to www.injurylawyerdallastexas.com or call 214-855-0034.

Accutane Maker Hit With 25 Million Dollar Verdict For Defective Drug

A man who claimed that acne drug Accutane caused irritable bowel disease that eventually resulted in the removal of his colon was awarded $25.1 million. Andrew McCarrell already prevailed over drugmaker Hoffmann-La Roche in a 2007 trial, in which a jury gave him $2.6 million. But the defense appealed and got a new trial in the same venue and with the same judge. This time the jury came back with a much larger compensatory damages award. McCarrell claimed that the label inadequately warned users of the possibility of irritable bowel syndrome. Plaintiff's counsel argued that company documents showed that it knew Accutane was a cause of irritable bowel disease, but it made no changes and didn't conduct any further testing to make it safe.

FDA Recommends Avandia Be Recalled Due to Heart Attack Injury

 

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.’s drug center, wrote that “there are multiple conflicting opinions” about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

“I await the recommendations of the advisory committee,” the agency’s commissioner, Dr. Margaret Hamburg, said Friday night. “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

Dangerous Drugs That Have Been Recalled Due To Threat of Injury

Below is a list of dangerous drugs that have been recalled due to a threat of possible injury as a result of taking them:

Avandia

Birth Control Patch

Dead Jaw

Depakote

Digitek

Ethex

 Fen-Phen

Fleet Phospho Soda

Kugel Mesh Patch

Levaquin

NuvaRing

Paxil

Pain Patch

Raptiva

Reglan

Stevens-Johnson Syndrome

Trasylol

Yaz

 

Pfizer To Pay Record Penatly For Drug Promotions

 

Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

"They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

To prevent backsliding this time, Pfizer's conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

 

FDA Warns Against Hydroxycut Diet Pill After One Death

 

Dieters who use the weight loss and energy-boosting Hydroxycut supplements should immediately stop, the US drug regulator warned Friday after reports of liver injuries and one death.

The US Food and Drug Administration (FDA) said one person had died from liver failure. The agency has received 23 reports of liver problems linked with use of the products, ranging from jaundice to damage requiring liver transplant.

In response, the FDA said, the maker of Hydroxycut -- Canada's Iovate Health Sciences Inc. -- had agreed to recall 14 products distributed by its US subsidiary.

"The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist," said Linda Katz, interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition.

Hydroxycut products are marketed for weight loss, water loss, and as fat burners, energy-enhancers and low carbohydrate diet aids under the brand names Iovate and MuscleTech.

Hydroxycut Cleanse and Hoodia products were not included in the recall, the FDA said.

The health regulatory body said it had not yet determined which ingredients or dosages of the products were linked with the risks. It also stressed that liver injury related to Hydroxycut use was rare but patients who reported the ailment had taken the doses recommended on the bottle.

Other health problems reported by users included seizures, cardiovascular disorder and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure, according to the FDA.