Dallas Personal Injury Lawyer Blog

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 Both authors recommended that Avandia be withdrawn.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 Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to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.