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[US FDA] Tygacil (tigecycline): Label Change - Increased Mortality Risk |
2010-09-03 |
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ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil. |
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[US FDA] Carbidopa/levodopa and Entacapone: Ongoing Safety Review: Possible increased cardiovascular risk |
2010-08-23 |
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Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death. |
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[US FDA] Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug |
2010-08-17 |
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ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drugs clinical benefit, for example, by showing that use of the drug improved a patients ability to perform life activities.
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[US FDA] Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis |
2010-08-12 |
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ISSUE: FDA notified healthcare professionals and patients that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated. |
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[MHRA] Information sent to healthcare professionals in July 2010: Saquinavir - Arrhythmogenic risk due to QT and PR prolongation |
2010-08-04 |
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Invirase (saquinavir) |
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[US FDA] Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia |
2010-08-02 |
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ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed. |
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European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim |
2010-07-23 |
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The European Medicines Agency is currently reviewing rosiglitazone to determine the impact of new data from recent publications on the risk of cardiovascular problems on the benefit- risk profile of these medicines. Prescribers in the European Union are reminded to strictly follow the current restrictions in the product information. |
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[US FDA] Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk |
2010-07-16 |
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ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer. |
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[US FDA] Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury |
2010-07-14 |
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ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception. |
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[US FDA] Quinine sulfate: New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions |
2010-07-09 |
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ISSUE: Due to continued reports of serious side effects in patients using Quinine "off-label" for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death. |
