A new drug that is good for the heart…
FDA approves dabigatran for stroke prevention, embolism, in AF patients
Good news for the German pharma Boehringer Ingelheim. The US FDA has recently approved its antithrombin dabigatran, marketed as Pradaxa for the US market. Pradaxa is indicated for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The approval comes with a guide that details the risk of serious bleeding as side effect. Other side effects include gastrointestinal symptoms, dyspepsia, stomach pain, nausea, heartburn, and bloating.
Existing drugs that might be bad for the heart…
Abbott Laboratories agrees to withdraw its obesity drug Meridia
Abbott Laboratories is voluntarily withdrawing its obesity drug Meridia (sibutramine) from the U.S. market due to safety issues. This is following a request from the US FDA following a review of data from a clinical trial data that indicated an increased risk for heart attack and stroke.
According to Dr. John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER):
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke. Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”
Invirase (saquinavir): Label Change – Risk of Abnormal Heart Rhythm
Safety warning on the antiviral drug Invirase (saquinavir): risk for arrhythmia (abnormal heart rhythms) due to changes in the electrical activity of the heart when used with Norvir (ritonavir), another antiviral medication. Both drugs are used to treat HIV infection. The warning has been added to the label of Invirase.
FDA: Include warnings on risk for class of prostate cancer drugs
Safety issues are also facing gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. Warnings are added to the labels concerning potential risk of heart disease and diabetes for those taking these medications. GnRH agonists are marketed in the US under the following brand names: Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex but are also available in generic form.