Montgomery Personal Injury Lawyer - Defective Drugs

Statins Work As Well As Vytorin

Shannon Weidemann — Sun, 30 Mar 2008 19:22:49 GMT

A new study just released has confirmed that Vytorin does not lower the risk of heart disease. Vytorin is a combination of a statin and a cholesterol lowering drug. The Enhance study showed that while Vytorin lowered cholesterol, it did not reduce plaque in arteries.

Doctors had embraced the drug because it does such a great job of lowering low-density lipoprotein, or LDL, the so-called bad cholesterol.
"Our strongest recommendation is that people need to go back to statins," said Dr. Harlan Krumholz of Yale University, who spoke on behalf of the panel at the American College of Cardiology meeting in Chicago.

Statins have been prescribed by doctors for a long time and have a good history of lowering cholesterol. Vytorin is marketed by Merck and Scherling-Plough. Sales for Vytorin are over $5 Billion a year. Testing is still being performed to see if the drug has any harmful side effects. That study will be completed in 2012.

Originally posted at InjuryBoard by Shannon Weidemann

Class I Recall on Medtronic Drug Pump

Shannon Weidemann — Thu, 20 Mar 2008 10:00:46 GMT

Medtronic warned doctors in January of an increase in inflammatory masses around their implantable infusion pumps. The warnings involved the SynchroMed and IsoMed infusion pumps. They deliver medications to patients. The FDA has now said that makes it a Class I recall.

The Food and Drug Administration defines a Class I recall as a situation in which there is a reasonable probability that use of the product will cause injury or death.
According to the FDA Web site, a medical device recall does not always mean that patients or doctors must stop using the product or return it to the company. A recall sometimes means the medical device needs to be checked, adjusted or fixed.

The masses are happening around the catheter attached to the pump. Medtronic says mention of masses as a side effect of the pump has been in product labeling since 2001.

If you would like to learn more about medical devices, please visit InjuryBoard's Medical Devices & Implants information page.

Originally posted at InjuryBoard by Shannon Weidemann

Contamination Found in Recalled Heparin

Shannon Weidemann — Fri, 07 Mar 2008 08:59:11 GMT

Researchers have found a contaminent in samples of recalled Heparin that are chemically similar to the drug but may explain the adverse reactions that have been reported. The FDA is unsure how the contaminant got into the Heparin. Initial testing did not reveal the contamination due to the similarity.

High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of the problem drug - a substance not found in batches of problem-free heparin.
The contaminant accounted for between 5 percent and 20 percent of some of the samples tested, what FDA's Woodcock called "significant quantities."
At those amounts, batches of heparin should have been flagged as subpotent in Baxter's routine quality tests - but they didn't, because the contaminant is so chemically close to real heparin that standard testing couldn't tell the difference, Woodcock said.

Baxter said the contamination was a naturally derived chemical. The FDA is trying to determine if it was added during processing or deliberately added. Portions of the Heparin were manufactured in China, which has seen a large number of recalls in the last year. Heparin is a blood thinner used during heart surgery and kidney dialysis.

Originally posted at InjuryBoard by Shannon Weidemann

China States Importing Countries Responsible for Drug Safety

Shannon Weidemann — Wed, 27 Feb 2008 08:59:54 GMT

The agency responsible for drug safety in China has stated that it is the responsiblity of importing countries and companies to inspect and certify drugs are safe. The statement follows a recall by Baxter for the blood-thinning drug heparin. Four people have died and there have been hundreds of reports of adverse reactions following the use of the drug.

"We attach high importance to this," the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.
But the SFDA said that based on international practice, "safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country."

The U.S. Food and Drug Administration (FDA) is holding inspections of the manufacturing facilities where heparin is made, both in the United States and China. It is unknown what about the heparin is causing the reactions. The U.S. and China signed an agreement in December for greater access in drug and food safety cases. The plant in China was labeled as a chemical manufacturer and was never inspected by the FDA or China's FDA.

Originally posted at InjuryBoard by Shannon Weidemann

Lipitor Ads with Dr. Jarvik Pulled

Shannon Weidemann — Mon, 25 Feb 2008 09:37:52 GMT

Pfizer made the decision today to pull drug ads for Lipitor with Dr. Robert Jarvik. Dr. Jarvik does not hold a medical license and there was some controversy over his use in the Lipitor drug ad. The ads have appeared on tv and in print since 2006. Dr. Jarvik invented the artificial heart. He does have a medical degree but is not licensed to practice medicine.

But House Democrats said the ads could be misleading to consumers because Jarvik appeared to be giving medical advice, even though he is not licensed to practice medicine. While Jarvik holds a medical degree, he did not complete the certification requirements to practice medicine.
Democratic Reps. John Dingell and Bart Stupak said Monday the company made the right decision.
"When consumers see and hear a doctor endorsing a medication, they expect the doctor is a credible individual with requisite knowledge of the drug," Stupak said.

There was also some controversy over the use of a stunt double used in one ad. It was made to look like Jarvik was rowing a boat but it was actually the stunt double. Pfizer claims they will be more clear in future ads with spokespeople.

Originally posted at InjuryBoard by Shannon Weidemann

Subpoenas Issued Over Ketek

Shannon Weidemann — Thu, 31 Jan 2008 10:02:11 GMT

The Congressional subcommitte Oversight and Investigations will be issuing subpoenas to FDA investigators over the antibiotic Ketek. They are looking for more information into fraudulant clinical data that was used to gain approval for the drug. Last year the FDA issued a black box warning label for Ketek, the highest safety warning. The subcommittee is investigating drug safety and whether the FDA and the drug's manufacturer knew of the bad data.

Sanofi-Aventis SA says one of its predecessors, Aventis, was not aware of fraud connected with a key Ketek study until after the study was submitted to the FDA. The agency has also said there was no intention to deceive the public. It did not know then that the entire study should not be relied upon.

The Department of Health and Human Services says that it is working with Congress in a way that will not compromise it's staffs ability to do their job. The subcommittee will hold another hearing on Ketek on February 12th.

If you would like to read more about drug safety, please visit InjuryBoard's FDA & Prescription Drugs information page.

Originally posted at InjuryBoard by Shannon Weidemann

Vytorin No Better than Older Drug

Shannon Weidemann — Fri, 18 Jan 2008 10:27:18 GMT

A study performed by Merck & Co. over two years ago showed that Vytorin, a cholesterol lowering and statin drug did not effectively reduce the amount of fatty deposits in arteries. Vytorin is a combination of Zetia, a cholesterol lowering drug, and Zocor, a statin. The study concluded that Zocor and Vytorin had the same affect on fatty deposits. There has been confusion over what that means for patients.

For Bufalino and colleagues, the advice is: Stay on the drug. "None of us are reacting by stopping the drug," he said.
He is not alone.
"There is a lot of distorted information out there," said Dr. Matthew Sorrentino, a preventive cardiologist University of Chicago Medical Center.

If you are taking Vytorin, speak with your doctor before you discontinue use. More studies are being done on the effectiveness of the drug to prevent heart attacks and strokes.

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

Originally posted at InjuryBoard by Shannon Weidemann

Blood Sugar Test Strips Recalled

Shannon Weidemann — Fri, 28 Dec 2007 19:39:51 GMT

Test strips used by diabetics to test their blood sugar levels have been recalled after it was discovered they were giving false readings. The recalled test strips were manufactured by Bayer and are used with the Contour TS blood glucose meter.

The test strips in question are sold predominately through mail order to be used only with the Contour TS meter.
The recall covers seven countries -- but most were sold here in the U.S. The recalled strips have lot numbers that begin with WK and are followed by the characters 7D, 7E, 7F or 7G.
Bayer says the strips may result in five to 17-percent higher blood glucose readings. Moore says the higher numbers can lead to an over-correction.

Please contact Bayer if you have the recalled test strips. They have fixed the faulty equipment on which they were made. They will send a free replacement for the diabetes test strips.

If you would like to learn more about recalled medical devices, please visit InjuryBoard's Medical Devices information page.

Originally posted at InjuryBoard by Shannon Weidemann

Merck Recalls HIB Vaccine

Shannon Weidemann — Wed, 12 Dec 2007 19:38:45 GMT

It was announced today that Merck is recalling 1.2 Million doses of its HIB and Comvax vaccine. The recalled vaccines are used to prevent pnuemonia, meningitis, and hepatitis B and are generally injected into children under the age of five. The plant were the vaccines are manufactured is contaminated, although Merck has not said with what.

The recall involves 11 lots of a Hib vaccine, Pedvaxhib, and two lots of a combination vaccine for both Hib and hepatitis B sold under the brand name Comvax, Merck said. The Merck vaccine is made at a manufacturing plant in West Point, Pa.
Federal health officials said the recall is precautionary and there's currently no evidence the vaccine itself was contaminated. However, Merck said because it could not assure the sterility of the vaccine it was recalling lots made since April.

The director of the CDC says the vaccine is not a threat to children that may have received it. Please contact your doctor if you have any questions or concerns about the recalled vaccine.

If you would like to learn more about vaccine recalls, please visit InjuryBoard's FDA & Prescription Drugs information page.

Originally posted at InjuryBoard by Shannon Weidemann

Deadly staph infections on the rise

Kimberly French — Thu, 18 Oct 2007 10:41:47 GMT

It's all over the news lately, and yesterday there was a staph infection death in Kern County, Virginia, prompting the entire school district to close.

A student reportedly died from a staph infection that proved resistant to antibiotic treatments. The story on MSNBC.com reports that more than a third of the population may carry staphylococcus infection. MRSA is the deadliest variety of staph infection, and has earned the name, Super Bug.

Reports this week showed that the Super Bug is killing thousands of people in the United States each year. It seems that schools, locker rooms, public areas and hospitals are all places where these staph infections are spreading.

Health care officials advise everyone to wash their hands often with soap and hot water; be wary of touching eyes, nose and mouth; and sanitize common areas used by many in offices, schools or other places.

Originally posted at InjuryBoard by Kimberly French