August 19, 2009 - An article published yesterday concluded that Avandia is associated with a significantly higher risk of heart failure and death than Actos. According to the authors, older patients with diabetes should not be prescribed Avandia because it lacks a distinct clinical advantage over Actos.
This is the most recent article exposing the serious health risks of Avandia. Thousands of individuals are currently pursuing legal claims against the makers of Avandia. The claims allege that the Avandia-users developed congestive heart failure or suffered a heart attack or death after taking the drug.
Thursday, August 20, 2009
Monday, August 10, 2009
First Fosamax Trial Begins Tomorrow
The first "bellwether" trial in the Fosamax litigation begins tomorrow. Merck & Co. currently faces more than 900 lawsuits that claim its osteoporosis drug Fosamax causes jawbone-tissue death. The trial is presided over by U.S. District Judge John Keenan in the U.S. District Court for the Southern District of New York.
"In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it's the first information about how jurors respond to the evidence," said Howard Erichson, a law professor at Fordham University in New York, on Bloomberg.com. The verdict reached in the first "bellwether" trial often guides future out-of-court settlements. Accordingly, all plaintiffs and attorneys involved in the Fosamax litigation will be watching this cases closely in the coming days and weeks to determine the potential value of their lawsuits.
"In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it's the first information about how jurors respond to the evidence," said Howard Erichson, a law professor at Fordham University in New York, on Bloomberg.com. The verdict reached in the first "bellwether" trial often guides future out-of-court settlements. Accordingly, all plaintiffs and attorneys involved in the Fosamax litigation will be watching this cases closely in the coming days and weeks to determine the potential value of their lawsuits.
Tuesday, July 28, 2009
Legislators Take Aim at Direct To Consumer Advertising
According to the New York Times, several bills have been introduced in the House to restrict or ban TV advertising for pharmaceuticals. However, restricting or banning these ads often runs afoul of free speech rights.
According to the NYT, Henry Waxman, Democrat from California, favors giving the FDA the power to bar consumer advertising for new drugs for an initial period after approval. Given that many drugs are approved before any real-world experience with the drugs has taken place many of the risks of a certain drug are not known. It is not until the drug has been on the market for several years that the risks are better understood. So, it makes sense to limit new drugs to patients who have not seen them on T.V., but have been prescribed to them by physicians who know them, their histories and medical conditions, not too mention the other prescriptions they take.
Delaying the availability of direct to consumer T.V. advertising may well have prevented numerous individuals from being injured by such "blockbuster" drugs as Vioxx, Lipitor, Yaz/Yasmin, and Ortho Evra just to name a few. Such limitations are not likely to be enacted any time soon because the broadcasters, newspaper and pharmaceutical lobbies are just too powerful to allow a law that would protect consumers, but hurt big business' bottom line.
According to the NYT, Henry Waxman, Democrat from California, favors giving the FDA the power to bar consumer advertising for new drugs for an initial period after approval. Given that many drugs are approved before any real-world experience with the drugs has taken place many of the risks of a certain drug are not known. It is not until the drug has been on the market for several years that the risks are better understood. So, it makes sense to limit new drugs to patients who have not seen them on T.V., but have been prescribed to them by physicians who know them, their histories and medical conditions, not too mention the other prescriptions they take.
Delaying the availability of direct to consumer T.V. advertising may well have prevented numerous individuals from being injured by such "blockbuster" drugs as Vioxx, Lipitor, Yaz/Yasmin, and Ortho Evra just to name a few. Such limitations are not likely to be enacted any time soon because the broadcasters, newspaper and pharmaceutical lobbies are just too powerful to allow a law that would protect consumers, but hurt big business' bottom line.
Monday, July 27, 2009
More Criticism of Avandia - Linked to Liver Failure and Death
Last week the diabetes drug Avandia came under fire again--this time for its link to liver failure and death. The group Public Citizen wrote in the journal Pharmacoepidemiology and Drug Safety that 11 adverse events reported to the FDA from 1997-2006related to death caused by liver toxicity were associated with Avandia.
According to the L.A. Times, Dr. James Floyd of Public Citizen was quoted as saying, "[b]ecause of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug."
Avandia has also been linked to increases in risk of heart attack, heart failure, bone fractures and vision loss from macular edema.
Lawsuits are being filed on behalf of individuals who took Avandia and suffered liver failure, heart attack, heart failure and stroke. Numerous lawsuits have been filed and are currently consolidated for pretrial proceedings in the U.S. District Court for the Eastern District of Pennsylvania.
According to the L.A. Times, Dr. James Floyd of Public Citizen was quoted as saying, "[b]ecause of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug."
Avandia has also been linked to increases in risk of heart attack, heart failure, bone fractures and vision loss from macular edema.
Lawsuits are being filed on behalf of individuals who took Avandia and suffered liver failure, heart attack, heart failure and stroke. Numerous lawsuits have been filed and are currently consolidated for pretrial proceedings in the U.S. District Court for the Eastern District of Pennsylvania.
Thursday, July 23, 2009
Lawsuits Filed Nationwide Claiming Injuries from Yaz and Yasmin
Women across the country are filing lawsuits claiming they suffered serious side effects from Yaz. The injuries these women suffered include blood clots, deep vein thrombosis, pulmonary embolism and stroke.
The lawsuits claim Bayer failed to warn of the serious injuries that could occur from the use of Yaz. The serious side effects appear to be caused by hyperkalemia, a condition caused by excessive amounts of potassium in the blood. According to the FDA the progestin used in Yaz and Yasmin called drospirenone or drsp can cause hyperkalemia.
In October 2008 the FDA cited Bayer's Yaz commercials for deceptive claims. The FDA's warning letter said the television commercials minimized the risks posed by the birth control pills. Bayer was forced to pull the ads and agreed to run new TV spots correcting the misinformation disseminated by its previous marketing campaigns.
The lawsuits claim Bayer failed to warn of the serious injuries that could occur from the use of Yaz. The serious side effects appear to be caused by hyperkalemia, a condition caused by excessive amounts of potassium in the blood. According to the FDA the progestin used in Yaz and Yasmin called drospirenone or drsp can cause hyperkalemia.
In October 2008 the FDA cited Bayer's Yaz commercials for deceptive claims. The FDA's warning letter said the television commercials minimized the risks posed by the birth control pills. Bayer was forced to pull the ads and agreed to run new TV spots correcting the misinformation disseminated by its previous marketing campaigns.
Tuesday, July 21, 2009
Lawsuits Filed Over Yaz and Yasmin Birth Control Pills
July 17, 2009 - Bayer Pharmaceuticals, maker of Yaz and Yasmin oral contraceptives is facing lawsuits regarding the safety of these drugs. The lawsuits allege that the FDA has received more adverse event reports for Yaz and Yasmin than other birth control pills.
Last year, Bayer Pharmaceuticals, the third largest pharmaceutical company in the world, agreed to run a $20million ad campaign correcting misstatements in a previous ad campaign, which downplayed risks and overstated benefits. Bayer agreed to run the ads following a warning letter from the FDA.
Last year, Bayer Pharmaceuticals, the third largest pharmaceutical company in the world, agreed to run a $20million ad campaign correcting misstatements in a previous ad campaign, which downplayed risks and overstated benefits. Bayer agreed to run the ads following a warning letter from the FDA.
Wednesday, July 1, 2009
FDA Alerts Healthcare Professionals of Black Box Warning for Chantix and Wellbutrin/Zyban
July 1, 2009 - The FDA alerted healthcare providers today that the manufacturers of varenicline (Chantix) and bupropion (Zyban, Wellbutrin and generics) must add new "Black Box" warnings highlighting the risk of serious neuropsychiatric symptoms in patients using these products. Symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.
The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Some of these cases may have been confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior. If varenicline or bupropion is stopped due to neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.
The possible risks of serious adverse events occurring while using varenicline or bupropion should always be weighed against the significant health benefits of quitting smoking.
The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Some of these cases may have been confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior. If varenicline or bupropion is stopped due to neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.
The possible risks of serious adverse events occurring while using varenicline or bupropion should always be weighed against the significant health benefits of quitting smoking.
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