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AstraZeneca 27 articles

Brilinta recalled due to medication mixup

AstraZeneca is recalling one lot of professional/physician sample bottles of the blood thinner Brilinta because it may contain a different medication, according to a Food and Drug Administration (FDA) Safety Communication. The recall comes after AstraZeneca received a report that one of its sample bottles of eight Brilinta 90 milligrams (mg) tablets actually contained another AstraZeneca-manufactured medication, Zurampic 200 mg. “Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure, which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor,” the FDA ... Read More

FDA lifts partial clinical hold placed on AZ’s head and neck cancer drug

Just weeks after the Food and Drug Administration (FDA) placed a partial clinical hold on AstraZeneca’s cancer study, preventing new patients with head and neck squamous cell carcinoma be added to clinical trials of the drug durvalumab, the agency announced it was lifting the hold. The FDA had ordered the partial hold after reports of adverse bleeding events in patients enrolled in two different clinical trials testing the drug as a mono therapy and in combination with the cancer drug tremelimumab. AstraZeneca said that the bleeding side effect that prompted the hold is a “known complication in treatments of head and neck ... Read More

New warning added to anti platelet drug Brilinta

The Warnings and Precautions section of the anti platelet drug Brilinta has been updated to include a new risk of bradyarrhthmia, or slow heart rate of under 60 beats per minute. Brilinta, known chemically as ticagrelor, is manufactured by AstraZeneca. It is in a class of medications known as P2Y12 platelet inhibitors. Brilinta is used to reduce the rate of cardiovascular death, myocardial infraction (heart attack), and strokes in patients with acute coronary syndrome or with a history of heart attacks. It is also indicated to reduce the rate of stent thrombosis in patients who have been stented for acute coronary ... Read More

Expert panel: FluMist ineffective at protecting from flu

AstraZeneca’s FluMist was once considered the gold standard for protecting people against the flu without using a traditional shot. But for the third year in a row the mist has failed, prompting an expert panel to recommend doctors stop giving it to patients. Instead, patients would fare far better if they endured the sting of the traditional flu shot. “We could find no evidence (FluMist) was effective,” said Dr. Joseph Bresee, a flu expert with the Centers for Disease Control and Prevention (CDC). Based on data that showed the FluMist provided no protection from the flu strain that sickened most people last ... Read More

Four Dangerous Diabetes Drugs

Type 2 diabetes is a growing epidemic around the world with an estimated one in 10 adults predicted to be suffering from the disease by 2030, according to the International Diabetes Foundation. Diabetes increases the risk for serious health complications including heart disease, kidney disease, cancer, blindness, dementia and amputations from neuropathy. Many diabetics require medication to help control blood sugar levels. There are dozens of diabetes treatments on the market and more being developed. But these drugs come at a risk. Here are five type 2 diabetes drugs that carry dangerous side effects: Invokana/Invokamet – Known chemically as canagliflozin, Invokana ... Read More

Black box warning for bleeding risks added to antiplatelet Brilinta

The safety label for the oral antiplatelet drug Brilinta (ticagrelor) has been updated to include a new boxed warning for serious bleeding risks and a lessening of effectiveness when taken with maintenance doses of aspirin above 100 mg. Brilinta, made by AstraZeneca, is used with low-dose aspirin to help prevent heart attacks and stokes in people with heart problems such as unstable angina or previous heart attack, as well as in patients with acute coronary syndrome (ACS). It is also used to reduce the risk of stent thrombosis in patients who have been stented for the treatment of ACS. Like ... Read More

Experimental psoriasis drug linked to suicidal thoughts

AstraZeneca is reviewing data on its experimental psoriasis treatment to determine whether it will move forward after reports that the medication caused patients to have suicidal thoughts. If the drug company continues development of the drug, if approved by the Food and Drug Administration (FDA), the agency may require the medication to carry a warning label. The drug, called brodalumab, is designed to treat psoriasis and related arthritic conditions. AstraZeneca was in partnership with Amgen Inc., but Amgen opted to pull out of the deal after reports of suicidality as a possible side effect. Analysts had initially projected that the ... Read More

AstraZenca pays U.S. $7.9 million to settle whistleblower complaint

London, England-based global drug maker AstraZeneca will pay the U.S. $7.9 million to settle a whistleblower complaint that it violated federal healthcare regulations by engaging in an illegal kickback scheme designed to boost sales of its acid reflux medication Nexium. The complaint, filed on behalf of the U.S. government by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle under the False Claims Act, alleges the multinational drug giant paid pharmacy benefit manager Medco Health Solutions for maintaining Nexium as the “sole and exclusive” prescription drug of its kind in Medco’s formularies. AstraZeneca paid Medco in the form of discounts on ... Read More

British Columbia refuses to cover some type 2 diabetes drugs

The British Columbia Medical Beneficiary and Pharmaceutical Services Division has delisted all sitagliptin drugs, including Januvia and Janumet, from its Pharmacare Benefits Program and will adjust its coverage of all other diabetes drugs in the class by February 2015. The agencies gave no reason for this action but experts speculate that it may be because sitagliptin has been linked to serious pancreatic side effects. Merck, maker of Januvia and Janumet, is fighting the action, saying the move limits therapeutic options for patients. Januvia works by enhancing the body’s own ability to control blood sugar levels by increasing insulin production when ... Read More

FDA panel questions benefits of experimental ovarian cancer drug

A study shows AstraZeneca’s experimental ovarian cancer drug olaparib produced a remarkable 83 percent reduction of disease progression, however a Food and Drug Administration (FDA) panel suggests those results are possibly a fluke, and question the validity of the company’s data collection. Data showed that patients treated with olaparib in clinical trials had a seven-month improvement in progression-free survival. Olaparib, which would be marketed under the brand name Lynparza, is designed as a maintenance therapy for relapsed ovarian cancer patients whose tumors have responded completely or partially to platinum-based chemotherapy. The drug works by blocking the activity of enzymes that ... Read More