If you have taken Avandia and suffered subsequent heart problems, you may have a legal claim and now is the time to take action. The Schlesinger Law Offices, P.A. currently represents the interests of those harmed by Avandia.
Avandia has been on the market since 1999. It's used by nearly 2 million people yearly worldwide, including a million in the United States, for the treatment of Type 2, or adult onset diabetes. It is sold alone as Avandia and in combination with other drugs as Avandamet and Avandryl.
Several studies have concluded that by taking Avandia one exposes themselves to an increased risk of suffering heart attacks and similar problems. Particularly, a study published in the New England Journal of Medicine determined that Avandia raises the risk of heart attack by 43 percent.
What is wrong with Avandia?
How do I know if I have been harmed by Avandia?The answer is you do not know if you have been harmed by Avandia. If you have taken Avandia, and are yet to notice any side effect, it is still possible that the drug will have an adverse effect. The defect of the drug is latent and can manifest itself at any time. If you are currently taking Avandia, of have taken any form of it in the past, we urge you speak with a medical professional immediately.
What can the Schlesinger Law Offices, P.A. do for you?We currently represent the interests of those who have been harmed by Avandia. GlaxoSmithKline, the manufacturers of Avandia may have known about the dangers of the drug, and still allowed it to be sold on the market. A free consultation is available by calling our office. It is important that you are aware of your legal rights.
Why should I contact the Schlesinger Law Offices, P.A. to handle my Avandia claim?The Law Offices of Sheldon J. Schlesinger has unparalleled experience in litigating on behalf of clients injured by defective drugs. Contact the Law Offices of Sheldon J. Schlesinger for free evaluation on your potential Avandia claim.
Glaxo's Avandia Risks Prompt Doctors to Switch Drugs
May 23 (Bloomberg) -- Boston doctor Annaswamy Raji says she was so alarmed by a study linking GlaxoSmithKline Plc's drug Avandia to heart disease that she immediately advised a diabetes patient to stop taking the medicine.
Research released May 21 by the New England Journal of Medicine provided evidence that Avandia raises the chance of a heart attack by as much as 43 percent. London-based Glaxo shares dropped for a third day, bringing the week's decline to 8.4 percent. The data caused U.S. lawmakers to question the government's drug-safety monitoring.
Some doctors say the risks uncovered in the study are outweighed by the drug's benefits. Patients should continue taking Avandia, the world's top-selling oral diabetes treatment with $3 billion in revenue last year, until Glaxo or U.S. regulators provide more guidance, they say. Meanwhile, some doctors, insurance companies and hospitals say they are reconsidering the use of Avandia.
Raji took an 83-year-old man off the drug because he ``is at a higher risk for heart disease and heart attack,'' said the Boston physician, an endocrinologist at Harvard Medical School and Brigham and Women's Hospital, in a telephone interview yesterday. ``Given the new information and until more data is available, I recommended that he stop this medication.''
Raji said her hospital is reviewing its use of Avandia. Other doctors said they were getting questions about its safety from patients.
``We figured we had about 30 calls from last night until this morning,'' said Farida Khan, chief of endocrinology at New York Methodist Hospital, who works in a practice with two other specialists. ``There are more messages in our offices that we haven't picked up yet.''
Glaxo shares fell 27 pence, or 2 percent, to 1,344 pence in London. They may reach their worst week since January 2003. The stock is little changed this year, trailing the 600 member Dow Jones Stoxx Index, which has risen 8.2 percent.
While the study findings raise some concern and indicate the need for more clear data, there is no need for alarm, according to an editorial released today by the Lancet, a prominent medical journal that published one of the largest studies on Avandia.
Doctors, patients and regulators can safely wait for the results of a pivotal trial, dubbed Record, that is specifically looking at heart risks among patients taking Avandia, known chemically as rosiglitazone, the editors said.
``To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed,'' they wrote. ``It would be premature to over interpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses.''
Of the 21 million people in the U.S. who have diabetes, two-thirds will die from either heart disease or a stroke, according to the American Diabetes Association. Doctors are trying to determine what to do about the 1 million who take Avandia after the study became public this week.
Talking to Doctors
``Our immediate concern is that patients aren't unduly alarmed by the reporting of the data,'' said Philip Thomson, a Glaxo spokesman, in a telephone interview. ``We are making every effort to communicate with physicians and patients our strong belief that Avandia is a highly effective treatment for type 2 diabetes.''
The findings raise concerns similar to those faced by Merck & Co. after the 2004 withdrawal of the painkiller Vioxx, responsible for $2.5 billion in annual sales. Results from a cancer study linked the drug to heart disease. The studies included in the analysis of Avandia similarly weren't intended to establish the product's effects on the heart.
Cleveland Clinic cardiologist Steven Nissen analyzed data from 42 studies involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo. Patients getting Avandia were 64 percent more likely to die from cardiovascular causes, though those findings could have resulted from chance, the researchers said.
There were 158 heart attacks and 61 deaths from cardiovascular causes among the patients in the studies, which generally lasted from six months to a year. John Buse, a diabetes specialist at the University of North Carolina School of Medicine in Chapel Hill, said he needs more information before switching patients to other drugs.
``It's an extremely well-done version of this kind of study,'' Buse said. ``It's possible that it's wrong.''
Glaxo has declined to release more data on Avandia that might clarify its effects on the heart, Buse said. In the meantime, most patients can probably continue taking Avandia for at least three months, or until a clearer picture emerges.
The European Medicines Agency advised patients today that they should continue taking the medicine and speak with their physicians at their next regular visit. Product information on the risk of cardiac events related to the drug was updated last year, the regulator said.
Other research indicates Actos, sold by Japan's Takeda Pharmaceutical Co., lowers blood sugar in the same way as Avandia and cuts levels of blood fats such as cholesterol that raise the risk of heart disease.
If the findings of this week's New England Journal report turn out to be related to fluid retention or weight gain, it may have consequences for rival treatments of the same type as Avandia. Those drugs are known as thiazolidinediones, or TZDs.
``We know TZDs cause fluid retention,'' Steve Kahn, co- author of an earlier trial called ADOPT, said in an interview in December.
Other types of drugs offer diabetes patients possible options, such as metformin, which slows the absorption of sugar; injections of the hormone insulin; and sulfonylureas, which stimulate the pancreas to make more insulin.
``Given the data that are available, the conservative approach would be to change to another class of drugs,'' or switch to Actos, said David Nathan, director of the diabetes center at Massachusetts General Hospital in Boston. ``In the absence of other balancing data, doctors need to take this seriously.''
U.S. medical experts are already urging lawmakers to require companies to conduct longer studies of new drugs, even after they are approved, and to make the results public to identify risks as quickly as possible. The Avandia findings stemmed from a lawsuit Glaxo settled with New York that required it to make the results of its studies public. Not all companies are similarly obligated.
``The health of the public would benefit from additional revisions to the drug-safety legislation,'' particularly as lawmakers work on a Food and Drug Administration revitalization bill that would give the agency additional powers, said Bruce Psaty, a cardiologist and drug safety expert from the University of Washington, in an editorial that accompanied the study.
Medco, Massachusetts General
Medco Health Solutions Inc., the biggest U.S. manager of drug benefits, based in Franklin Lakes, New Jersey, is considering whether to add information on Avandia's possible heart-attack risk to an alert system of potential side effects that it sends to doctors.
Nathan said doctors at Massachusetts General will meet to determine whether to make new recommendations for the drug. Blue Cross and Blue Shield of Massachusetts will also review whether the study warrants any action, said Chris Murphy, a spokesman.
Other drugs to treat diabetes have side effects, North Carolina's Buse said. High doses of insulin can drive blood sugar to a low level, called hypoglycemia, which can lead to unconsciousness and accidents. Sulfonylureas have also been associated with heart disease in studies that haven't been confirmed. About 1 in 20 patients can't take metformin because of diarrhea, bloating and other side effects.
``The message we've asked our staff to give patients is to stay on Avandia,'' Buse said. ``If they're nervous, they can come in to discuss their options. The only bad decision they can make is to stop Avandia without talking to us.''
UBS Weighs Glaxo's Avandia Liability
LONDON - GlaxoSmithKline P.L.C. could be facing liabilities up to $6 billion over personal-injury lawsuits relating to its diabetes drug Avandia, UBS analysts said in a note made public Friday.
The UBS note, which comes a week after a highly critical report on the drug by the U.S. Senate Finance Committee, said the risk came from more than 13,000 personal-injury lawsuits outstanding in the United States.
Glaxo has major operations in the Philadelphia area.
"As U.S. Avandia contributes 1 percent to sales, our concerns are solely on personal-injury lawsuits," analysts said in a note headed by analyst Gbola Amusa.
UBS said the poll of experts suggested Glaxo's liability was in the range of $1 billion to $6 billion.
"We expect liability below the midpoint of this range and note GlaxoSmithKline has underperformed by around $2.5bn already," the note said.
The first of two U.S. federal bellwether trials, which will likely provide an indicator of court decisions on the other cases, is due to start on June 1 in Pennsylvania.
The U.S. Senate report criticized GlaxoSmithKline's handling of heart risks with the drug, alleging that Glaxo minimized the drug's safety risks and withheld important data from the U.S. Food and Drug Administration.
The FDA added a warning about potential heart attacks to Avandia in 2007, but the scope of that risk is still not fully understood.
Glaxo has said that the Senate criticism "mischaracterizes and distorts" the company's record.
UBS said that it believes data on Avandia support the drug's continued use, but added that "nonscientific political pressure from Congress will likely be as important as science at FDA in the coming months; and, product withdrawal, if it occurs, could put GlaxoSmithKline at the top end of our liability range."
UBS cut its price target on Glaxo from 1,550 peace (about $23.50) to 1,475 peace, but kept its buy recommendation.
American depositary receipts in Glaxo, traded on the New York Stock Exchange, were priced early this afternoon at $37.44, up 7 cents.
The greatest wealth is health. -Virgil