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Diabetes Drug Warning

Diabetes Drug Injury Lawyers

Diabetes Drug Injury Lawyers

Prescription medications designed to treat Type 2 diabetes work by stimulating the release of certain chemicals in the brain, pancreas, and bloodstream to improve blood glucose levels in the body. These medications also reduce insulin resistance in the liver. Scientific studies have linked several Type 2 diabetes drugs to serious side effects, such as heart attacks, certain types of cancers, acute pancreatitis, and more. At Ferrer, Poirot & Wansbrough, were dedicated to helping the victims of prescription drugs get compensation for their medical bills, lost wages, and pain and suffering. If you or someone you love was injured by a Type 2 diabetes medication, our experienced diabetes drug injury lawyers want to help. Call us at (800) 210-8503 or fill out a free initial consultation form . An FDA advisory committee concluded that taking the prescription Type 2 diabetes drug Onglyza (saxagliptin) can increase the risk of heart failurea fatal condition. These medications can cause serious health complications that may leave you in the hospital, out of work, and facing expensive medical bills. Ferrer, Poirot & Wansbrough can help you get the money you deserve for your or your loved ones drug injuries. We have the experience to build a strong case for youcall today. Actos is a registered trademark of Takeda Pharmaceutical Company Limited. Invokana and Invokamet are registered trademarks of Janssen Pharmaceuticals, Inc. Onglyza is a registered trademark of AstraZeneca PLC. This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration, Takeda Pharmaceutical Company, Janssen Pharmaceticals, Inc., or AstraZeneca PLC. Continue reading >>

Fda Issues New Warning For 5 Diabetes Drugs

Fda Issues New Warning For 5 Diabetes Drugs

FDA Issues New Warning for 5 Diabetes Drugs Saxagliptin and alogliptin may increase the risk of heart failure The Food and Drug Administration (FDA) has reported that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure especially in patients who already have cardiovascular or renal disease. The FDA is adding new warnings to the affected drug labels about this new safety risk. Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors that are indicated for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.In 2015, approximately 386,000 patients received a dispensed prescription for saxagliptin-containing products (saxagliptin and saxagliptin-metformin), and 56,000 patients received a dispensed prescription for alogliptin-containing products (alogliptin, alogliptin-pioglitazone, and alogliptin-metformin) from the U.S. outpatient retail pharmacy setting.The drugs impacted by this safety communication include: Oseni (alogliptin/pioglitazone; Takeda ) The FDA reviewed two large trials conducted in patients with heart disease. Findings from each trial revealed that more patients who received saxagliptin- or alogliptin-containing drugs were hospitalized for heart failure vs. patients who received placebo. In one of the trials, SAVOR, 3.5% of patients who received saxagliptin were hospitalized for heart failure vs. 2.8% in the placebo group. In the second trial, EXAMINE, 3.9% of patients treated with alogliptin were hospitalized for heart failure vs. 3.3% in the placebo group. Risk factors for hospitalization heart failure include a history of heart failure or renal impairment. RELATED:Impact of T2DM Meds on Heart Failure Hospitalization Explored Healthcare professionals should con Continue reading >>

Feline Diabetes | Cornell University College Of Veterinary Medicine

Feline Diabetes | Cornell University College Of Veterinary Medicine

Avoiding inducing inappropriately low blood glucose levels with therapy Cats with diabetes are most often treated with injectable insulin. Oral drugs for humans (hypoglycemic medications) such as glipizide rarely work in controlling diabetes in cats. Insulin injection (see Figure 1) can be taught to most owners and, with a bit of experience, both owners and cats usually adapt to these injections very well. There are a variety of insulin preparations available, and each works for a different duration and has different effects on the ups and downs of blood glucose. Ideally, your veterinarian will perform a 12-24 hour glucose curve, during which insulin is administered intermittently and blood glucose is measured to establish the type of insulin and dosing frequency that best controls blood glucose while avoiding inappropriately low blood glucose levels (hypoglycemia). Your veterinarian may recommend feeding your cat a diet restricted in carbohydrates, which has been shown to improve control of blood glucose levels. When it comes to diet, its important to help your cat combat the weight loss that often occurs as a result of this disease. In diabetic cats that are underweight, this often means feeding multiple meals per day or allowing access to food at all times. If your cat is overweight, however, work with your veterinarian to institute a weight loss program, as managed weight loss in overweight diabetic cats will likely help the cat maintain steadier glucose levels. The optimal timing of meals for diabetic cats is controversial. Many veterinarians recommend feeding at the time of insulin injection to avoid a dangerous drop in blood glucose levels. However, there is no definitive evidence that the timing or frequency of meals in diabetic cats protects them from insulin- Continue reading >>

Diabetes Drugs Linked To Higher Risk For Rare But Deadly Complication

Diabetes Drugs Linked To Higher Risk For Rare But Deadly Complication

A new class of type 2 diabetes drugs called SGLT2 inhibitors could increase the risk of a rare, life-threatening complication of the disease called ketoacidosis, a new study warns. SGLT2 inhibitors include prescription medications such as canagliflozin, dapagliflozin and empagliflozin. Brand names are Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi. These drugs first became available in 2013, but in 2015 the U.S. Food and Drug Administration issued a warning about an increased risk for diabetic ketoacidosis when SGLT2 inhibitors are used. The condition typically occurs in people with type 1 diabetes. And while it is uncommon in people with type 2 diabetes, case reports have shown it can occur with type 2 disease, according to the study authors. Ketoacidosis can cause vomiting, abdominal pain, shortness of breath and swelling in the brain. Left untreated, the condition can be fatal, the researchers said. The new study "essentially confirms what doctors had already suspected," said diabetes expert Dr. Stanislaw Klek, an endocrinologist at NYU Winthrop Hospital in Mineola, N.Y. "Fortunately, the rate of diabetic ketoacidosis is still very low and should not prevent the usage of this medication class," he added. "It is important to be aware of this potential complication and monitor for symptoms of diabetic ketoacidosis, particularly during periods of illness." In the new study, researchers at Brigham and Women's Hospital in Boston analyzed data from 40,000 people with type 2 diabetes. They found that those taking SGLT2 inhibitors were twice as likely to develop diabetic ketoacidosis than those taking another class of diabetes drugs called DPP4 inhibitors (drugs such as Januvia and Onglyza). Still, the risk to any one patient remains very slim, the researche Continue reading >>

Sglt2 Inhibitors, Farxiga, Invokana, Jardiance. Dangerous New Drugs

Sglt2 Inhibitors, Farxiga, Invokana, Jardiance. Dangerous New Drugs

The FDA recently gave its approval to several new drugs that are part of a new class of diabetes drugs, the SGLT2 inhibitors. All have very troubling side effects. More are awaiting approval. The first of these was Johnson & Johnson's drug canagliflozin, which is marketed in the U.S. as Invokana. It is also sold in a combination pill containing metformin as Invokamet. These sodium-glucose co-transporter-2 (SGLT-2) inhibitors lower blood sugar by blocking reabsorption of glucose by the kidney and increasing its excretion in urine. However, recent findings suggest that though these drugs increase excretion of glucose, they simultaneously increase the production of glucose by stimulating the secretion of glucagon. More about that can be read HERE. The manufacturers also claim that they cause weight loss--always a potent selling point for a diabetes drug. Most recently, a questionable research study has been the basis of the claim that one of these drugs actually prevents heart attacks. The facts are quite different, but drug company flacks are saturation bombing family physicians with materials that make it sound like they should put every patient with Type 2 on this wonderful, new drug, which is priced at $8.77 a pill or $263.10 for a monthly supply. They shouldn't. When the first of these drugs, Invokana (canagliflozin), came up for approval, the committee of "experts" who reviewed it were ambivalent about it because the company's own, [most likely, statistically manipulated], clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event [mainly strokes and some heart attacks] compared with just one patient taking a placebo. After that, the imbalanc Continue reading >>

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

AFREZZA is a man-made rapid-acting inhaled insulin breathed in through your lungs and is used to control high blood sugar in adults with diabetes. AFREZZA is available by prescription only. AFREZZA is not for use in place of long-acting insulin. AFREZZA must be used with long-acting insulin in people who have type 1 diabetes. AFREZZA is not for use to treat diabetic ketoacidosis. It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months). It is not known if AFREZZA is safe and effective in children under 18 years of age. What is the most important information I should know about AFREZZA? AFREZZA can cause serious side effects including: Sudden lung problems (bronchospasms). Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will perform a detailed medical history, physical examination, and will give you a breathing test (called spirometry) to check how your lungs are working. Who should not use AFREZZA? Do not use AFREZZA: During episodes of low blood sugar (hypoglycemia). If you have chronic lung problems such as asthma or COPD. If you are allergic to regular human insulin or any of the ingredients of AFREZZA as this may cause a significant and severe allergic reaction. What should I tell my healthcare provider before using AFREZZA? Before using AFREZZA, tell your healthcare provider about all your medical conditions, including if you: Have lung problems such as asthma or COPD. Have or have had lung cancer. Are using any inhaled medications. Smoke or have recently stopped smoking. Have kidney or liver problems. Are pregnant, plan Continue reading >>

Fda Adds Boxed Warning To Type 2 Diabetes Drug Invokana Over Amputation Risk

Fda Adds Boxed Warning To Type 2 Diabetes Drug Invokana Over Amputation Risk

FDA adds boxed warning to type 2 diabetes drug Invokana over amputation risk FDA adds boxed warning to type 2 diabetes drug Invokana over amputation risk Wearable insulin delivery device improves HbA1c levels in type 2 diabetes 10 May 2017 The US Food and Drug Administration (FDA) has announced that a new warning must be added to the label of Invokana (canagliflozin) , a type 2 diabetes drug. Data from two large clinical trials found that Invokana was associated with an increased risk of leg and foot amputations compared to placebo. This led the FDA to post a statement on its website insisting that Invokana now carries a boxed warning, reserved for the most serious possible adverse events. Invokana, an SGLT2 inhibitor, was approved in the EU in 2013 to lower blood glucose levels in people with type 2 diabetes . The drug works by helping to remove excess sugar through urine. But the increased risk of lower limb amputation has heightened in recent years. In May 2016 the FDA noted a correlation between Invokana and amputation risk , but required more evidence to prove causality. The European Medicines Agency has also warned healthcare professionals of this risk while Janssen Pharmaceuticals, the drug's manufacturers, wrote to doctors in 2016 detailing these observations. This new FDA warning was made following the findings of two trials: CANVAS and CANVAS-R, which found leg and foot amputations were twice as common in patients treated with canagliflozin compared to placebo. In the CANVAS trial the risk of amputation among Invokana-treated patients was equivalent to 5.9 out of 1,000, compared to 2.8 out of 1,000 among those given placebo. The CANVAS-R trial found the amputation risk was equivalent to 7.5 out of every 1,000 Invokana patients compared to 4.2 out of every 100 Continue reading >>

Amputation Risk Linked To Diabetes Drug

Amputation Risk Linked To Diabetes Drug

The new drug warning EVERY diabetic needs to see There’s an urgent new warning EVERY diabetic needs to see — and it comes STRAIGHT from the FDA. One of the most commonly used new drugs given to diabetics — a medication that’s done BILLIONS in sales — can lead to a horrific side effect. I hope you haven’t eaten before I share the details, because this risk is pretty disturbing. In fact, it’s every diabetic’s nightmare: amputation. The new “black box” warning finds the drug canagliflozin (a.k.a. Invokana and Invokamet) can DOUBLE that risk. This drug can cause you to lose your toes, part of your foot, the entire foot, or even the leg itself. Some folks are in and out of the hospital for multiple operations, losing another piece of their body with every trip. And some folks lose all or part of BOTH legs… all because of the drug that was supposed to HELP them. One study the FDA looked at found that 7.5 people out of every 1,000 who take the drug end up with an amputation… or three amputations for every 400 patients. That’s a shockingly high number, especially since diabetic amputations have been on the decline over the years — and that’s what has me really concerned. While the headlines have focused on the horrific consequences, I’m worried about what’s happening BEFORE those limbs are removed, because it could be an indication that the drug is increasing the damage of the disease in other ways. Diabetics are prone to amputations — especially of the toes, feet, and legs — because of a combination nerve damage and poor circulation. That causes wounds to fester, often unnoticed — and by the time the damage is spotted, it could be much too late. The amputation risk could be a sign that this medication is causing or accelerating nerve dam Continue reading >>

Fda Warns Of Amputation Risk Linked To Newer Diabetes Drug

Fda Warns Of Amputation Risk Linked To Newer Diabetes Drug

agency officials have directed(www.fda.gov) that a new boxed warning be added to the package label of the medication canagliflozin (Invokana, Invokamet, Invokamet XR) to advise prescribers and patients of a heightened risk for leg and foot amputations associated with the drug. Canagliflozin is a member of the class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Marketed as single-ingredient products or in combination with other diabetes drugs such as metformin, SGLT2 inhibitors are FDA-approved for use in conjunction with diet and exercise to lower blood glucose in patients with type 2 diabetes -- specifically, by inhibiting renal glucose reabsorption. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and these drugs are not approved for use in these patients. The MedWatch alert, issued on May 16, was based on results of two large clinical trials -- CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) -- which showed that leg and foot amputations occurred about twice as often in patients treated with the drug as in those who took a placebo. Specifically, according to a related FDA drug safety communication,(www.fda.gov) the CANVAS trial found the risks of amputation over a year's time were equivalent to 5.9 out of every 1,000 patients for canagliflozin compared with 2.8 out of every 1,000 patients for placebo. In the CANVAS-R trial, the comparative risks were equivalent to 7.5 per 1,000 patients for canagliflozin and 4.2 per 1,000 patients for placebo. Although amputations involving the toe or middle of the foot were the most common, amputations of the leg -- both Continue reading >>

Type 2 Diabetes Drug Lawsuit – Risk Of Diabetic Ketoacidosis

Type 2 Diabetes Drug Lawsuit – Risk Of Diabetic Ketoacidosis

As more and more Type 2 diabetes drugs hit the market, managing the disease becomes less of a hassle for many. Unfortunately in some cases, the risks of taking these medications outweigh the reward and users are finding the serious side effects they experience are just not worth it. Though side effects can occur with any of the diabetes drugs available – or any drug for that matter – some of the most serious issues are related to sodium-glucose co-transporter (SGLT2) inhibitors, which are the newest class of type 2 diabetes medications. These drugs have been available for approximately two years and already, users have suffered numerous adverse reactions, many of which were life-threatening. There are several SGLT2 medications on the market. The first approved was Invokana, which made it to market despite five of the 15 members of the advistory panel voting against approval because of the drug’s potential link to heart attack. Farxiga, which had its original application denied by the FDA due to concerns of the drug’s effect on the liver, was later approved in the winter of 2014. Members of the FDA approval panels were not the only ones concerned about SGLT2 inhibitors. The advocacy group Public Citizen voiced its concern for the medications, stating they do not think the information available is adequate and that there is evidence the drugs cause harm. They have SGLT2 inhibitors on their list of “do not use” medications on their website. SGLT2 Inhibitors Cause Minor and Severe Side Effects Health officials have taken notice and following a number of adverse reactions to SGLT2 inhibitors, the FDA issued a warning to health care professionals in the spring of 2015 concerning a link to diabetic ketoacidosis. The agency had received 20 reports, but hundreds more Continue reading >>

'clear Promise': Diabetes Drug Reversed Memory Loss In Mice With Alzheimer's, Researchers Find

'clear Promise': Diabetes Drug Reversed Memory Loss In Mice With Alzheimer's, Researchers Find

A team of Chinese and British researchers has discovered that a drug originally created to treat diabetes shows “clear promise” as a treatment for Alzheimer’s disease, since it significantly reversed memory loss in mice. News of the potential breakthrough was published this week in Brain Research. “[The drug shows a] clear promise of being developed into a new treatment for chronic neurodegenerative disorders such as Alzheimer's disease," the scientists’ report reads. “The drug improved memory formation in a mouse model of Alzheimer’s disease,” they said, adding that amyloid plaque load, inflammation and oxidative stress were all visibly reduced. The new diabetes drug is a triple receptor that combines GLP-1, GIP and Glucagon, three biological molecules known as “growth factors.” According to Newsweek, researchers tested the receptor in mice specifically created to express certain genes associated with Alzheimer's disease in humans and waited for them to age for a couple of months and sustain some brain damage. Once given the drug, the mice were put through a maze test and results showed a clear improvement in their learning and memory formation. "These very promising outcomes demonstrate the efficacy of these novel multiple receptor drugs that originally were developed to treat type 2 diabetes but have shown consistent neuro-protective effects in several studies," said lead researcher Christian Holscher said, in a press release from Lancaster University. The drug improved memory formation in a mouse model of Alzheimer’s disease - Chinese and British research team "Clinical studies with an older version of this drug type already showed very promising results in people with Alzheimer's disease or with mood disorders," Holscher added. "Further dose-r Continue reading >>

Fda Drug Safety Communication: Fda Confirms Increased Risk Of Leg And Foot Amputations With The Diabetes Medicine Canagliflozin (invokana, Invokamet, Invokamet Xr)

Fda Drug Safety Communication: Fda Confirms Increased Risk Of Leg And Foot Amputations With The Diabetes Medicine Canagliflozin (invokana, Invokamet, Invokamet Xr)

[ 5-16-2017 ] Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional. Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type Continue reading >>

Avandia - Type 2 Diabetes Drug History & Fda Warnings

Avandia - Type 2 Diabetes Drug History & Fda Warnings

The Type 2 diabetes drug Avandia is known for being at the center of one of the biggest drug-safety scandals in recent history. Once a blockbuster drug, Avandia was discredited in the U.S. and all but pulled from the market after thousands of people who took the drug experienced heart problems. The U.S. Food and Drug Administration (FDA) imposed restrictions on Avandias use but later removed them. The drug remains on the market today as a medication to help control high blood sugar. Black Box Warnings: Congestive heart failure The FDA approved Avandia in 1999 to treat Type 2 diabetes along with diet and exercise . It is part of a class of drugs known as thiazolidinediones (TZD) or glitazones, which also includes Rezulin (troglitazone) and Actos (pioglitazone). Type 2 diabetes (formerly known as adult-onset diabetes) is a condition in which the body either does not produce enough insulin or cannot effectively use what it does produce. Insulin is a hormone made in the pancreas that enables the cells of the body to use sugar (glucose). Without insulin, blood glucose levels can rise to abnormal levels a condition called hyperglycemia which, in addition to causing increased thirst and a need to urinate frequently, can lead to medical emergencies such as diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar nonketotic syndrome (HHNS, also referred to as hyperglycemic hyperosmolar state). Avandia is known as an insulin sensitizer because it makes Type 2 diabetes patients more sensitive to insulin, helping them to better maintain safe glucose levels. Avandia does not cause the body to make more insulin. It is designed to improve the way the body uses insulin by decreasing the amount of glucose the liver releases. The drug is also sold in combination with other medications Continue reading >>

Metformin, Oral Tablet

Metformin, Oral Tablet

Metformin oral tablet is available as both a generic and brand-name drug. Brand names: Glucophage, Glucophage XR, Fortamet, and Glumetza. Metformin is also available as an oral solution but only in the brand-name drug Riomet. Metformin is used to treat high blood sugar levels caused by type 2 diabetes. FDA warning: Lactic acidosis warning This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects. Lactic acidosis is a rare but serious side effect of this drug. In this condition, lactic acid builds up in your blood. This is a medical emergency that requires treatment in the hospital. Lactic acidosis is fatal in about half of people who develop it. You should stop taking this drug and call your doctor right away or go to the emergency room if you have signs of lactic acidosis. Symptoms include tiredness, weakness, unusual muscle pain, trouble breathing, unusual sleepiness, stomach pains, nausea (or vomiting), dizziness (or lightheadedness), and slow or irregular heart rate. Alcohol use warning: You shouldn’t drink alcohol while taking this drug. Alcohol can affect your blood sugar levels unpredictably and increase your risk of lactic acidosis. Kidney problems warning: If you have moderate to severe kidney problems, you have a higher risk of lactic acidosis. You shouldn’t take this drug. Liver problems warning: Liver disease is a risk factor for lactic acidosis. You shouldn’t take this drug if you have liver problems. Metformin oral tablet is a prescription drug that’s available as the brand name drugs Glucophage, Glucophage XR, Fortamet, and Glumetza. Glucophage is an immediate-release tablet. All of the other brands are extended-r Continue reading >>

Actos Recall: France & Germany Recall Diabetes Drug

Actos Recall: France & Germany Recall Diabetes Drug

Because of the link between Actos and side effects like congestive heart failure and bladder cancer, the FDA has added black box warnings and safety updates to the labeling. France and Germany have taken steps to recall the drug, preventing more people from being harmed by these adverse events. Popular diabetes drug Actos has been linked to bladder cancer and heart failure, but the FDA hasnt issued a recall. However, in light of the drugs serious side effects, the FDA is closely monitoring ongoing postmarket studies . In 2007, the FDA issued a black box warning highlighting the connection between ACTOS use and congestive heart failure. The warning urges that patients be closely monitored for excessive, rapid weight gain, shortness of breath, and edema, all signs of congestive heart failure. On June 15, 2011, the FDA warned consumers that use of the drug for a period of more than a year could increase the risk of bladder cancer. The warning was based on a five-year interim analysis of an ongoing, ten-year epidemiological study of 193,099 patients with diabetes, conducted by the drugs manufacturer, Takeda, in conjunction with insurer Kaiser Permanente. The agency advised doctors not to administer Actosto patients with active bladder cancer, and to be cautious when prescribing it to patients with a history of bladder cancer. The FDA noted that, while the interim analysis did not conclusively support a statistically significant link between Actosuse and bladder cancer, there was some correlation in patients with high/prolonged dosage. The agency added language about the link to bladder cancer to the WARNINGS AND PRECAUTIONS section of the ACTOS label. In 2011, both France and Germany issued a recall for Actosin response to a study authored by Frances national health insura Continue reading >>

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