Death magnifies Pradaxa hemorrhage concerns

(Reuters) - The death of an elderly man from a massive brain hemorrhage after a routine fall suggests that bleeding complications from Boehringer Ingelheim's Pradaxa blood clot preventer are largely irreversible, according to the Journal of Neurosurgery.

 

The recently approved drug is the first in a new class of oral medicines called direct thrombin inhibitors, approved to prevent strokes among patients with a dangerous irregular heartbeat called atrial fibrillation that mostly affects the elderly.

 

U.S. regulators said in December they were evaluating other cases of bleeding associated with the drug, whose chemical name is dabigatran, but advised patients to continue the medicine for now.

 

Three doctors from the University of Utah monitored and described the worsening condition, and ultimate death, of the 83-year-old man who was evaluated at their medical center for what seemed at first a rather routine fall, according to the report Tuesday in the journal's online edition.

 

Initially, the patient was fully alert and oriented and could respond to verbal commands, and his neurological exam produced no findings of great concern, the clinicians said.

They said CT scans revealed small, superficial areas of hemorrhage in his brain, but that within two hours after arriving at the hospital new scans showed extensive progression of brain hemorrhaging.

 

Efforts to stop the hemorrhaging, including intravenous fluids and a protein called recombinant factor VIIa, proved ineffective and the patient fell into a deep coma and died soon afterward, the report said.

 

"In the event of traumatic hemorrhage in patients receiving dabigatran ... there are currently no effective reversal agents" to neutralize the drug, the report said.

 

ADVERSE EFFECTS

 

Familiarity with Pradaxa is critical in order for medical personnel to take quick action with admittedly limited available means to control catastrophic bleeding, the report said.

Researchers speculated that dialysis might remove 35 percent to 60 percent of Pradaxa from the bloodstream in two to three hours, but noted that option was not taken with the elderly patient. "By the time of his deterioration it was too late to implement effectively."

 

Since balance problems and falls are common for elderly patients, cases of brain hemorrhage even from a minor trauma are likely to increase as more patients get prescribed Pradaxa, the researchers said.

 

"Bleeding is unfortunately one of the adverse effects of all anticoagulants," said John Smith, senior vice president for clinical development at Boehringer Ingelheim.

 

Although there is no antidote to Pradaxa that could control bleeding, including among fall victims like the elderly man, Smith said patients taking Pradaxa in a large clinical trial had a 59 percent lower overall incidence of intracranial bleeding than patients taking warfarin.

 

Pradaxa was approved by U.S. regulators in October 2010 for stroke prevention in patients with atrial fibrillation. It is the first of a new crop of blood clot preventers meant to replace warfarin -- a longtime oral treatment that carries serious bleeding risks and requires routine blood monitoring and stringent dietary restrictions.

 

The report said patients taking the highest dose of Pradaxa in a large clinical trial sponsored by Boehringer had a similar overall rate of brain hemorrhage as those taking warfarin, while having a lower annual incidence of stroke. But the lack of a reversal agent in the event of catastrophic hemorrhage remains a handicap, they said. 

 

The new medicine from privately held German drugmaker Boehringer Ingelheim competes with Xarelto, a pill from Johnson & Johnson and Bayer AG, approved four months ago in the United States that works by blocking a protein called Factor Xa. 

 

Another Factor Xa inhibitor from Bristol-Myers Squibb Co and Pfizer Inc, called Eliquis, is being reviewed by the U.S. Food and Drug Administration for approval.

 

It is deemed by Wall Street to be the best of the new oral anticoagulants because it proved both safer and more effective than warfarin in large clinical trials. Industry analysts have speculated Eliquis could reap annual sales of $4 billion or more.

 

 

Call Gary S. Tucker & Associates if you or a loved one has taken Pradaxa.  (281/445-5777)

Stanford guilty of $7 billion swindle

Texas financier R. Allen Stanford was convicted today of all but one of 14 charges that he swindled investors out of more than $7 billion.  Sanford, 61, could receive 20 years in prison for the most serious of his crimes – much longer if the judges elects to run his sentences one after the other. 

 

            Prosectors told a jury, which deliberated for four days, that the head of the Galleria-area based Stanford Financial Group had executed one of the biggest Ponzi schemes in U.S. history over the course of 20 years.  Stanford’s defense, meanwhile, had largely blamed his former financial officer.  The trial was postponed early in 2011 due to Stanford’s addiction to anti-anxiety drugs that occurred while in jail.  The federal government shut down the financial empire in February 2009 with Sanford’s personal wealth estimated at $2.2 billion.  Few victims of the swindle have received any compensation.

 

Driver gets out after wreck, is killed by oncoming truck

A man died in a traffic crash after another vehicle slammed into his truck following an earlier wreck in Montgomery County on Wednesday night.  The wreck occurred on FM 105 near McCaleb Road along Lake Conroe about 8:30 p.m., according to the Department of Public Safety.Troopers said the man was in his truck after being involved in a minor wreck when second vehicle smashed into his truck. The pickup driver, who has not been identified, died.  According to television stations KPRC and KTRK, the driver involved in the second wreck was suspected of being drunk at the time.  No other information was immediately available.

Teen dies after crashing into flatbed truck near Kingwood

HOUSTON – A teenage driver was killed Tuesday (February 14, 2012) night after crashing into the back of a disabled flatbed truck in northeast Harris County.  Harris County Sheriff’s deputies said a flatbed truck was traveling north on the Eastex Freeway at North Park Plaza when the truck got a flat tire around 11 p.m.  The truck driver was trying to move the truck from the center lane to the shoulder when an 18-year-old speeding in a Toyota 4Runner slammed into the back of the flatbed, according to deputies.  The teen was pinned inside the Toyota until he was pried out by heavy rescue. He was transported to LBJ Hospital, where he later died.   The driver of the flatbed was not hut.

Train, rig collide in southeast Houston

A freight train collided with an 18-wheeler truck this afternoon in southeast Houston, authorities said.  The train struck the rig about 1:30 p.m. Tuesday (February 14, 2012) along the 2500 block of Galveston near the 610 South Loop, Houston police said.  The force of the impact apparently split the truck cab from the trailer, officials said.  Houston police were continuing to investigate later in the day.

Proposed Interim Redistricting Maps Released

Texas Attorney General Greg Abbott today issued the following statement on the proposed interim redistricting maps for Texas’ 2012 elections:

“The proposed maps minimize changes to the redistricting plan passed by the Legislature and, as the U. S. Supreme Court required, makes changes only where necessary. The Texas Attorney General’s Office has worked with a wide range of interest groups to incorporate reasonable requests from all parties to the extent possible without compromising the will of the Texas Legislature. Even though these proposed interim maps aren’t fully supported by all interest groups, modifications have been incorporated based on requests made by all parties. Today’s maps should allow the court to finalize the interim redistricting maps in time to have elections in April,” Attorney General Abbott said.

The proposed House and Congressional interim redistricting maps are the result of an agreement between the State of Texas and the Texas Latino Redistricting Task Force – which includes Texas LULAC, MALDEF, GI Forum, Southwest Voter Registration Education Project, Domingo Garcia, The Mexican American Bar Association of Texas, and La Fe Policy Research and Education Center. The proposed Congressional interim redistricting map is also supported by Congressman Henry Cuellar.

Although the Mexican American Legislative Caucus (MALC), the Black Legislative Caucus and the NAACP have not agreed to support the proposed maps, those maps include modifications that address some of the primary concerns those plaintiffs raised during negotiations with the State.

 

1 million birth control pill packets recalled, may not prevent pregnancy

Pfizer said on Tuesday it was recalling about a million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.

 

            "As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," according to a Pfizer statement on the U.S. Food and Drug Administration website.

Pfizer found that some packets of the drugs had too many active tablets, while others had too few.

 

            Oral birth control products use a series of 21 drug tablets and 7 inactive sugar tablets to regulate the menstrual period while providing contraception. The birth control pills posed no health threat to women, Pfizer said, but it urged consumers affected by the recall to "begin using a non-hormonal form of contraception immediately." The drugmaker said the issue involved 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets.

 

            A company spokeswoman said the problem was caused by both mechanical and visual inspection failures on the packaging line, The Associated Press reported. She said the problem has been corrected.  The pills were manufactured by Pfizer and marketed by Akrimax Pharmaceuticals and shipped to warehouses, clinics and retail pharmacies nationwide, the company said.