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FDA begins posting list of drugs with potential safety issues on its web site

Wendi Lewis — Mon, 08 Sep 2008 16:42:11 GMT

A list of prescription drugs currently under investigation by the FDA for safety issues is now available online.

The U.S. Food and Drug Administration began posting the list on its web site in September. The new policy is required as a result of a drug safety bill passed by Congress last year. Drugs included on the list are under investigation because of complaints reported to the FDA by drug companies, doctors and patients.

The FDA collects reports of possible side effects through its Adverse Event Reporting System. Only drugs submitted through this system will be included on the list. According to a story in the Washington Post, last year the FDA received more than 480,000 reports of potential reactions to drugs.

The FDA will update the list every three months. The first list included 20 medications and the potential problems associated with each. But, just because a drug is included on the list does not mean the drug is not safe, only that the FDA is investigating it.

According to a report on National Public Radio, FDA officials said they are trying to walk a fine line between being more open with the public and avoiding needless scares.

Some consumer groups worry that patients will stop taking necessary medication if they see it listed on the FDA web site.

The FDA’s Dr. Janet Woodcock told NPR, “My message to patients is this: Don’t stop taking your medicine. You should continue taking it unless your doctor advises you differently.”

The FDA hopes that by posting the list of drugs under investigation, they will be able to improve communication with the public and with doctors. They hope this will lead to overall improvement in drug side-effect reporting and verification.

Consumer advocates told NPR the list is a good start, but should include more information to be truly effective.

Also, it is not clear at this time how the FDA will inform the public if a drug originally included on the list is cleared of suspected safety risks.

The list is available on the FDA web site.

Originally posted at InjuryBoard by Wendi Lewis

Recalled Digitek Digoxin Tablets Could Affect Many with Heart Failure and Atrial Fibrillation

Margaret Embry — Thu, 30 Apr 2009 11:59:23 GMT

Digoxin is a drug used to treat congestive heart failure and atrial fibrillation by making the heart beat stronger and with a more regular rhythm. To understand the importance this drug plays in those who suffer from the above mentioned conditions, a general understanding of these conditions is needed.

According to US Recall News from April 2008,

A class I recall is being issued on all Digitek (digoxin) tablets, which may contain twice the approved level of digoxin.The existence of double-strength pills pose a risk of digitalis toxicity, which can result in nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death.

Congestive Heart Failure (CHF), according to the American Heart Association, is a condition in which the heart is not able to pump enough blood to the body's other organs. The heart is working, but not as efficiently as the body needs. Because of this, a person with CHF cannot exert themselves because they become short of breath and tired.

As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the tissues. Often swelling (edema) results. Most often there's swelling in the legs and ankles, but it can happen in other parts of the body, too. Sometimes fluid collects in the lungs and interferes with breathing, causing shortness of breath, especially when a person is lying down.

Atrial Fibrillation (AF) is a disorder in which the heart's two small upper chambers (the atria) quiver instead of beating effectively. Blood isn't pumped completely out of the atria, so there is a chance for it to pool and clot. If a piece of a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation and about 2.2 million Americans suffer from AF.

Originally posted at InjuryBoard by Margaret Embry

FDA shows caution in evaluating new heart drug, delays report

Wendi Lewis — Mon, 29 Sep 2008 17:31:16 GMT

Could the U.S. Food & Drug Administration (FDA) finally be showing caution in its evaluation of potential new medications? After being thrashed by the media and the public in recent months for its apparent inability to protect us from insufficiently tested drugs that turn out to be ineffective or, worse, downright dangerous, the FDA seems to be putting on the brakes in its consideration of a new drug offered by manufacturer Eli Lilly and Daiichi Sankyo.

On Sept. 24, Forbes.com was anticipating a decision on Lilly and Sankyo’s new blood thinner, prasugrel, which would be used to treat heart disease. Forbes reported that the FDA had decided in June after an initial review of the drug to delay its decision until Sept. 26.

However, today the FDA delayed approval of the drug for a second time. According to an Associated Press report, the agency says it still has not completed its review of the drug, which was submitted in January. The AP quotes Lilly spokesperson Jennifer Stotka as saying the evidence from prasugrel trials and studies is a “very large, complex submission,” and that she is not surprised at the FDA request for more time.

Prasugrel would be a direct competitor with Plavix, the leading drug for treatment of cardiovascular disease, manufactured by Sanofi-Aventis and Bristol-Myers Squibb.

According to a second Forbes report released today upon news of the second delay, prasugrel is designed to treat patients with acute heart conditions who are at risk of developing blood clots. The news agency says prasugrel’s manufacturers paid for a study of 14,000 patients to test the medication, which it says prevented more heart attacks than Plavix. However, the report says, the drug also caused more dangerous bleeding, with deaths as a result almost canceling out the gain in cardiovascular benefit.

Results of this study, the TRITON-TIMI 38 trial, were apparently enough cause for concern that the FDA is taking its time to weigh its decision.

Forbes says cardiologists expect the drug to ultimately gain approval, although with “significant warnings” for those at higher risk for bleeding. The report says the drug also has hopes for wide use in angioplasty procedures, where drug-coated stents are used to open a clogged artery.

For now, however, the wait is on.Originally posted at InjuryBoard by Wendi Lewis

Vytorin and cancer: real threat?

Tom Methvin — Wed, 03 Sep 2008 17:35:36 GMT

Vytorin, manufactured by Merck & Co. and Schering-Plough was introduced as the newest weapon in the fight against “bad” cholesterol. But last week the U.S. Food and Drug Administration dealt another blow that strengthens the argument that perhaps it’s the drug that’s bad, when it linked Vytorin use to an increased risk of cancer.

Vytorin, a combination of Merck’s Zocor (simvastatin), and Schering-Plough’s Zetia (ezetimibe), began taking hits in December 2007, when the FDA reported that the combination of Zetia and statin drugs, like Zocor, can increase the risk of liver damage and disease.

Then, in February 2008, the results of the drug manufacturers’ ENHANCE study, which were delayed for two years after the study’s April 2006 completion, pointed to the fact that Vytorin showed no significant benefit in slowing arterial plaque buildup. In fact, the study showed that patients taking Vytorin might actually have more plaque growth than patients taking only a simvastatin.

Now, in the worst news yet for the drug, the FDA issued a MedWatch alert Aug. 21 to inform healthcare professionals that the agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial of a possible link between Vytorin use and the increased risk of cancer and cancer death.

The FDA announced there are 3 months left until completion of the final SEAS study report, and that it would need an additional 6 months after receiving that data to evaluate the clinical data and other relevant information. In the meantime, they are advising patients to continue taking Vytorin and consult with their physician.

The announcement of the possible Vytorin-cancer link caused controversy, with some experts arguing that the results of the SEAS study are incomplete and may be a fluke. However, Dr. Jeffrey Drazen, editor of The New England Journal of Medicine, warned that the implications should not be “brushed aside,” according to a report by USA Today released this morning.

Dr. Drazen, along with four other editors, including two statisticians, published an editorial in the NEJM skeptical abut the safety of Vytorin and saying that it has raised uncertainty among physicians and patients.

According to the USA Today article, researchers found evidence that patients who took Vytorin appear to have at least a 40 percent greater risk of dying from cancer than those who took a placebo.

The results of the SEAS trial, which involved 2,000 patients, are being compared to two other ezetimibe studies, SHARP and IMPROVE-IT, which are still ongoing, and which involve more than 10,000 patients combined.

Some researchers say that a definite answer about the connection between ezetimibe and cancer will not be known until those studies are complete in 2012, USA Today reports. However, other experts warn that it is just as impossible to rule out a link between the drug and cancer, according to the news report.

Originally posted at InjuryBoard by Tom Methvin

Physicians say litigation helps ensure drug safety

Wendi Lewis — Mon, 18 Aug 2008 10:27:03 GMT

Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often "overwhelmed" by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a "key defense mechanism" to protect consumers by insuring drug safety and providing a method to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, "the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug's manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA's judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine's position, the AP report states.

Originally posted at InjuryBoard by Wendi Lewis

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