AstraZeneca has agreed to pay $1 billion in damages to settle allegations that the company failed to adequately warn consumers about the potential dangers of taking pioglitazone, a popular diabetes drug.
The settlement follows a settlement reached in the United States in the summer of 2007 and was announced by the US attorney general in a lawsuit filed in the federal court in Boston against the company, AstraZeneca, which had a drug in a different class of drugs to the one used by Eli Lilly.
The settlement, which was reached in the US district court in Boston, has since been confirmed by the New York State District Court, where the case is being tried.
The US and British companies were ordered to pay $1 billion in damages to the plaintiffs for failing to adequately warn the public about the potential risks of taking pioglitazone.
The US government said that it would sue AstraZeneca in the case if the company failed to adequately warn consumers of the potential dangers of taking pioglitazone, the main diabetes drug used by hundreds of millions of Americans.
The company, which has been linked to diabetes as a side effect of a prescription drug called Actos, had been under investigation by the Food and Drug Administration for the drug's safety in the United States since the late 1990s, but the company has since been barred from selling the drug.
The US and British companies' lawyers are seeking unspecified damages for their failure to warn consumers of the risk of a potentially fatal side effect of the drug.
The settlements will be subject to court approval by the US District Court in Boston. The settlement will resolve the allegations in the lawsuit and will be subject to the full cost of the settlement to resolve the case.
In the US, AstraZeneca had agreed to pay $1 billion in damages to resolve a class action against two generic drug makers -- Eli Lilly and Mylan -- for failing to adequately warn consumers about the risk of taking a diabetes drug that was linked to a number of adverse events.
The settlement resolves the claims in the first instance by Mylan and the others, the company said. However, the company's attorneys are seeking unspecified damages for the failure to adequately warn consumers of the risk of a potentially fatal side effect of the drug.
AstraZeneca is one of more than 20 global pharmaceutical companies with more than $2 billion in annual sales.
The company's share of revenues rose to $1.17 per share in the third quarter of 2007, to $3.35 per share in the same period in 2008, according to IMS Health.
The company's share of revenues rose to $1.16 per share in the quarter of 2008, to $3.13 per share in the same period in 2008, according to IMS Health.
The settlement resolves the allegations in the first instance by Mylan and the others, and will resolve the second-quarter 2008 earnings statements for the company.
The settlement includes a $10 million payment to the plaintiffs, which will be paid by the company's shareholders.
The settlement is expected to be paid by AstraZeneca.
In July 2008, AstraZeneca agreed to pay $3.5 billion to resolve a class action lawsuit filed by three pharmaceutical companies -- Mylan, Actos and Teva -- for a diabetes drug known as Pioglitazone.
The case was brought by the plaintiffs, Mylan, and Actos, which are also known as Actos, for alleged failure to warn about a possible connection between pioglitazone and the development of Type 2 diabetes.
In the class action lawsuit, Mylan, Actos and Teva had filed a class action against four companies, including Mylan's pharmaceutical division, Teva Pharmaceuticals Ltd., Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd. and Teva Pharmaceutical Industries Ltd. for alleged failure to adequately warn consumers of the risk of a potentially fatal side effect of the drug.
The case, filed in Boston Superior Court on May 14, 2008, alleged that the defendants failed to adequately warn the public about the possible danger of taking a medication called Actos, which was linked to heart attacks and strokes in more than 80 percent of cases.
In the Actos class action lawsuit, Mylan alleged that the company knew about the risks of the drug but failed to adequately warn consumers of the risk of the drug, which was known to be linked to heart attacks and strokes in more than 80 percent of cases.
The lawsuit alleged that the company failed to provide adequate warnings to consumers, as well as to the government about the potential dangers of taking the drug, which was not adequately disclosed.
Actos is an oral diabetes medication that is used as part of a comprehensive treatment regimen to help manage blood sugar levels. It belongs to a class of drugs called thiazolidinediones, which work by reducing the amount of glucose produced by the liver. These medications work by reducing the number of glucose molecules in the blood, which helps prevent the unpleasant side effects associated with high blood sugar.
As with any medication, there are potential side effects associated with Actos, although the most common ones are headache, diarrhea, nausea, and abdominal pain. More serious side effects are more rare, but they include seizures (convulsions), mood changes, and bone loss. These side effects can be life-threatening and must be treated properly.
In cases of serious side effects, your doctor may recommend antifungal medication. It may also be necessary to adjust your diet and exercise regimen. Your doctor will monitor your progress and may recommend bone mineral density (BMD) and lipid management.
The starting dose of Actos varies depending on your condition and the severity of your blood sugar levels. The standard dose for type 2 diabetes ranges from 15 mg to 40 mg daily, taken with meals that contain about 30% of the blood sugar. For adults with type 2 diabetes, this may range from 15 to 40 mg daily. For adults with diabetes that does not require this high dose, your doctor may increase your dose to 30 to 45 mg daily.
To reduce the risk of side effects, your doctor may increase your dose to 45 mg daily. This medication is not recommended for use in children as it can cause harm to the developing baby.
It's important to follow your doctor's instructions and not to drink alcohol when taking Actos. It's also important to maintain a healthy diet and exercise regimen to reduce the risk of side effects.
Inform your doctor about any pre-existing conditions or medications you are taking before starting treatment with Actos. Actos can interact with other medications and cause side effects. Be sure to talk to your doctor about any concerns you have before starting treatment.
If you have any questions regarding Actos treatment, contact your doctor directly. Your doctor can discuss with you the best course of action for managing your condition.
Contact your doctor immediately if you experience any side effects, including:
If you are pregnant or breast-feeding, discuss with your doctor before starting treatment with Actos. While in the process of discussing possible risks with your doctor, talk to your doctor about your health before starting treatment.
Read more about Actos inContact
. Ozdoron (Dosine)Pioglitazone (Ozdoron) is a selective cyclosporine type 2 immunoglobulin preparation that is used to treat all types of allergies. The most common allergenic includes food preservatives, non-prescription, and herbal products. Ozdoron can be taken during or up to 1 year after a food allergy diagnosis. It is usually taken with or without food.
What is Actos? Actos (Pioglitazone) is an oral diabetes medication used as part of a comprehensive treatment regimen to help manage blood sugar levels. It is a thiazolidinediones (TZD) drug that works by reducing the amount of glucose produced by the liver. This process helps prevent the unpleasant side effects associated with high blood sugar.Actos is used to help control blood sugar levels in people with type 2 diabetes. It is sometimes used along with other diabetes medications or to help lower blood sugar levels in people who do not respond to other diabetes medications. Actos is not for use by children or elderly people. Actos is not recommended for use in women or children.
Actos is not recommended for use in children or elderly people. It may not be as effective in adults with diabetes as in the elderly. It is sometimes used along with other medications to help manage blood sugar levels in children and adults with diabetes.
Actos (pioglitazone) is used to treat diabetes (Type 1 diabetes). Actos is a Type 2 diabetic medicine that helps manage blood sugar levels. Actos is also used for the treatment of kidney, heart, and lung disease. Actos may also be used for purposes not listed in this medication guide.
Actos is a medication that contains pioglitazone, an active ingredient that helps reduce glucose production in the liver and improve insulin sensitivity in the body. Actos is an anti-diabetic drug. Actos can reduce the amount of sugar produced in the liver. Actos may also be used for the treatment of heart failure, which is a type of heart failure. Actos also may be used to treat symptoms of high blood pressure (hypertension), which can affect the heart and blood vessels. Actos is used to lower the risk of developing heart attacks and strokes. Actos should be used in combination with a reduced-calorie diet and exercise program to help improve blood sugar control in patients with diabetes. Actos is an anti-psychotic drug and should be used with caution in patients with liver disease.
Actos is a prescription medication. It is not intended for use by women or children. Talk to your health care provider if you have any medical conditions.
Read More About This Medication GuideA prescription medication is a drug that is prescribed for a condition. Actos is an anti-diabetic drug that helps manage blood sugar levels. Actos is also used to treat kidney, heart, and lung disease. Actos also is used for the treatment of symptoms of high blood pressure (hypertension) (hypertensive heart disease). Actos is also used for the treatment of symptoms of high blood pressure (hypertension). Actos can be used alone, along with other anti-diabetic drugs, to lower the risk of stroke, heart attack, or kidney damage. A patient taking Actos should see their doctor for further medical advice.
Read More About This DrugActos also is used to treat symptoms of high blood pressure (hypertension) (hypertensive heart disease). Actos is also used to treat symptoms of high blood pressure (hypertension) (hyensive heart disease). Actos can also be used to treat symptoms of benign prostatic hyperplasia (BPH). Actos can also be used to treat symptoms of a kidney infection. Actos may also be used to treat symptoms of benign prostatic hyperplasia (BPH).
Actos can reduce the risk of stroke, heart attack, or kidney damage. Actos may also be used for the treatment of symptoms of benign prostatic hyperplasia (BPH).
A patient should see their doctor for further medical advice. They should be aware that Actos is an anti-diabetic drug and Actos also may be used to treat symptoms of high blood pressure (hypertension) (hyensive heart disease).
Actos is used to treat symptoms of high blood pressure (hypertension) (hyensive heart disease).
Actos is used as an oral medication. Actos can be taken with or without food. Actos is also used to reduce the risk of developing bladder cancer in patients taking medicines that treat cancer.
Directions
Take one tablet with water by mouth as directed by your doctor, usually once a day. It can be taken with or without food. If taken early enough, the effects of the drug will gradually lessen. If you miss a dose, take it as soon as possible. However, if it is less than 12 hours old, wait 2 or 3 days and start taking the drug. You can take your dose at any time of the day and evening while still in the body. Do not take a double dose to make up for a missed dose. If you stop taking your dose, the effect of the missed dose will wear off and your next dose will be carried out in a week. If you are on medicines that treat cancer, your doctor may instruct you to start with a lower dose. Skip your missed dose and continue your normal dosage. You can take your dose at any time of the day and evening. Do not use your diet, physical activity and mental health medicines at the same time.
Side Effects
Most side effects do not require any medical attention. They may go away after you have a few days. You should consult a doctor if your side effects do not improve or if they continue.
Side effects that are usually mild to moderate in amount, and that can go away after a few days, include:
headache (bone pain), stomach pain, muscle aches, back pain, skin rash, or itching.
changes in mood or behavior, such as:
behaviour changes, including irritability, anxiety, or problems concentrating, or changes in mood or personality.
chemotherapy-juvenaemic children (adolescents 12 years and older).
injection into the stomach or intestines.
injection to treat an abnormal growth of the pancreas or thyroid gland.
cancers and ulcers.
changes in the way your liver works.
diarrhea, especially after meals.
cough.
coughing up blood.
diarrhea that is not limited to the stomach.
fainting.
fainting, usually not accompanied by an increased pulse or blood pressure.
liver problems.
liver problems that can affect the liver.
kidney problems.
urinary obstruction.
urinary retention.
urinary tract infection.
stomach infection.
stomach infection that can cause frequent infections.
infection with the bacteria Escherichia coli.
infection with Shigella sonnei.
cough, sore throat, and fever.
stomach or intestine problems.
chronic fatigue syndrome.
coughing up breath.
coughing up cough.
coughing up coughing up blood.
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