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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

Alli Side-Effects May Outweigh Benefits

Staff Writer — Mon, 18 Jun 2007 09:32:16 GMT

A new diet drug has hit the shelves with the FDA's approval, but users may want to be wary of the side effects. Alli, manufactured by GlaxoSmithKline, is supposed to help people lose 50% more weight than other dietary supplements.

Alli blocks enzymes that digest fat, preventing the body from absorbing about a quarter of the fat eaten. The undigested fat is then excreted. One study of Alli showed that dieters who took the drug along with diet and exercise over a year lost about three pounds more than people who only dieted and exercised.

This drug is a low-dose version of the prescription-only drug Xenical which has been on the market since 1999.

Doctors say that the drug will help people lose weight, but if users eat foods high in fat they will definitely feel the side effects.

Side effects include oily discharge, diarrhea, and uncontrollable bowel movements. Many patients who took Xenical did not end up refilling their prescriptions because they could not handle the side effects.

There have also been claims by the non-profit group Public Citizen, that the drug may increase the risk of colon cancer. The drug has been shown in studies to cause precancerous lesions in the colons of mice.

The FDA responded to the group by saying that there is not enough evidence linking Alli to colon cancer to not approve the drug.

For more information on this subject, please refer to our section related to Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Staff Writer

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

Diabetes Drug Byetta Linked to Pancreatitis

Courtney Mills — Wed, 17 Oct 2007 09:42:50 GMT

The FDA has reviewed 30 cases of acute pancreatitis in patients taking Byetta, a drug used to treat type II diabetes. The agency suspects a link between Byetta and pancreatitis in some of these cases.

Amylin Pharmaceuticals will be updating the information about acute pancreatitis in the PRECAUTIONS section of the Byetta label. Patients on Byetta should be alert for any signs of pancreatitis, such as vomiting and persistent severe abdominal cramps. If patients on Byetta experience these symptoms, discontinue use immediately.

Byetta is taken as an injection, and has been shown to cause weight loss in addition to helping with the symptoms of type II diabetes.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Do ADHD drugs have heart risks?

Staff Writer — Mon, 17 Sep 2007 12:12:30 GMT

Forbes magazine and the Associated Press report that the Food and Drug Administration (FDA) and Agency for Healthcare Research and Quality announced today that it will take a closer look at data from children who have been using ADHD drugs to determine whether these medications can cause heart problems.

Apparently there have been a number of reports of deaths, heart attacks and strokes among children and adults using widely prescribed ADHD drugs such as Shire's Adderrall, Eli Lilly's Strattera, and Johnson & Johnson's Concerta.

The FDA wants drug makers to get to the bottom of these reports and find out whether or not their medications are increasing the risk of stroke, heart attack and other adverse reactions to the drugs. The FDA will begin studying data showing about 1/2 million children and adults who have taken these ADHD drugs for seven years or more.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Staff Writer

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

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