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safety label 40 articles

Lawsuits against Bayer alleging neurological side effects from Mirena IUD will not be centralized

Nine lawsuits against Bayer Healthcare Pharmaceuticals alleging the company’s Mirena IUD caused neurological conditions will not be consolidated into a multidistrict litigation because there are just too few to justify the motion. Plaintiffs had asked that the lawsuits be centralized in Tennessee; Bayer opposed centralization or to have them consolidated in New York. Bayer already faces multidistrict litigation with its Mirena intrauterine device over uterine perforation, a different injury. These nine lawsuits claim that the Mirena IUD contraceptive device releases a synthetic hormone that can cause neurological problems, including a type of brain damage known as pseudo tumor cerebra (PTC) ... Read More

Johnson and Johnson, Janssen settle dozens of Topamax birth defects lawsuits

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have agreed to settle 76 lawsuits in Pennsylvania court over allegations that its anti-seizure and migraine drug Topamax caused birth defects in babies born to women who used the drug during pregnancy. News of the settlement comes a month after a Philadelphia County jury awarded $3 million in damages to the family of a 5-year-old who claimed the companies did not update the safety label of Topamax to reflect data that showed the drug increased the risk of cleft lip and cleft palate in newborn babies. Johnson & Johnson and Janssen also ... Read More

Hypertension drug Letairis linked to birth defects, infertility

Letairis (ambrisentan), a medication used to treat pulmonary hypertension, has updated its safety label to warn that studies of the drug have consistently shown that laboratory animals given the drug produce offspring with birth defects. The medication can cause embryo-fetal toxicity, or harm to fetuses, when given during pregnancy and is contraindicated in women who are pregnant. The drug is labeled as a Category X Pregnancy Drug, meaning it should not be used in women during pregnancy. The drug’s medication guide warns that women should not be pregnant when starting the medication and that they must use two acceptable forms ... Read More

New pancreatitis warnings added to diabetes drugs Tradjenta, Jentadueto

The safety labels for the type 2 diabetes drugs Tradjenta (linagliptin tablets) and Jentadueto (linagliptin and metformin) have been updated to include a warning that using the drugs may cause a type of pancreas inflammation known as pancreatitis, which in some cases can be fatal. Tradjenta and Jentadueto, which both include the active ingredient linagliptin, are in a class of oral medications known as dipeptidyl peptidase 4, or DPP-4 inhibitors. Other drugs in this class include Januvia and Onglyza. The warnings state that there have been post-marketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. Doctors who ... Read More

Diabetes drug Tradjenta linked to acute pancreatitis, fatal pancreatitis

The safety label for the type 2 diabetes treatment Tradjenta (linagliptin) has been updated to warn that there have been reports of acute pancreatitis, including fatal pancreatitis, in patients taking the medication. Doctors and patients are advised to take special note of potential signs and symptoms of pancreatitis, and if the condition is suspected, to discontinue Tradjenta and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at an increased risk for developing the condition while using the drug. Tradjenta is an oral medication that is designed to reduce blood sugar levels in patients with ... Read More

FDA proposes new rule to allow generic drug makers ability to update safety labels

The Food and Drug Administration (FDA) is taking steps to allow manufacturers of generic drugs permission to change safety labels when new information about potential side effects is discovered. Currently, generic drug makers are required to have the same safety labels as their brand-name counterpart. For years, citizen groups have petitioned the FDA to take measures to ease the regulations that prevent generic drug companies from providing new information about potential risks associated with their products. Brand-name drugs go through a rigorous approval process through the FDA during which they must provide data from clinical trials demonstrating the drug’s safety ... Read More

High doses of NSAIDs put users at risk of heart attacks, strokes

Millions of people take nonsteroidal anti-inflammatory drugs (NSAIDs) to treat mild to moderate pain, but new research shows the medication may put users at risk for heart attacks and strokes. NSAIDs are in a class of painkillers that includes the medications aspirin, ibuprofen and naproxen. They are sold over-the-counter in both generic version and brand names such as Advil, Motrin and Aleve. Prescription NSAIDs are also available. The most common side effects associated with the drugs includes stomach upset and ulcers. They may also interfere with kidney function. The new study showed that high doses of these drugs taken regularly can increase ... Read More

New warnings added to Chantix label include cardiovascular events, psychiatric symptoms

The safety label for the smoking cessation drug Chantix (varenicline) has been updated to include new warnings about cardiovascular risks. The warning is based on a large, combined analysis of clinical trials that showed more serious cardiovascular events occurred in people who were taking Chantix. The report was released late last year by the Food and Drug Administration (FDA), which added that the risks were uncommon in both the Chantix and placebo groups, and that it is difficult to determine whether the excess risk of serious heart events among patients taking Chantix was due to the drug or simply chance. ... Read More

FDA approves new safety label for blood thinner Pradaxa

Pradaxa

The Food and Drug Administration (FDA) has approved new language on the safety label of the blood thinner Pradaxa to include new warnings, precautions and contraindications informing patients not to take the drug if they have ever had or plan to have a valve in their hearts replaced. The updated safety label and medication guide comes after an interim analysis of results from a study showed  increased incidents of thromboembolic events (blood clots) and bleeding events in patients with mechanical prosthetic heart valve replacements who used the new anticoagulant. Pradaxa was approved by the FDA in 2010 to prevent strokes ... Read More

New warnings placed on cholesterol-lowering statins

New warnings of serious muscle damage are being placed on the safety labels of cholesterol-lowering statins, according to the Food and Drug Administration (FDA). The revised labels state that there have been reports of immune-mediated necrotizing myopathy (IMNM) associated with statin use. IMNM is a rare disorder in which the muscle fibers suffer massive destruction. The warnings will be placed on the following statin medications: Advicor (niacin ER/lovastatin) Tablets Altoprev (lovastatin) Extended-Release Tablets Crestor (rosuvastatin calcium) Tablets Juvisync (sitagliptin/simvastatin) Tablets Lescol XL (fluvastatin sodium) Extended-Release Tablets Lipitor (atorvastatin calcium) Tablets Livalo (pitavastatin) Tablets Mevacor (lovastatin) Tablets Pravachol (pravastatin sodium) Tablets ... Read More