Tagged Articles

generic 99 articles

Risperidone side effects send patients to the emergency room

Adverse effects of antipsychotic medications such as Risperdal (risperidone) send more than 20,000 people in the United States to the emergency room each year, prompting the American Psychiatric Association to issue an advisory to clinicians to carefully evaluate patients before prescribing the drugs to ensure that the use of antipsychotic medications are clinically warranted. Antipsychotic adverse effects were the cause of three times more emergency room visits than side effects from sedatives, four times more than stimulants, and five times more than antidepressants. The antipsychotic side effects that drive most people to the emergency room for treatment include extreme restlessness, ... Read More

Long-term use of antipsychotic Risperdal in children linked to reduced bone mass

Long-term use of the antipsychotic drug Risperdal in children can reduce bone mass and prevent bone growth, according to a new study presented at the American Society of Clinical Psychopharmacology’s annual meeting. Similar results were found in children treated long-term with antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Risperdal, also known by the generic risperidone, is used to treat symptoms of schizophrenia, bipolar disorder, and irritability with autism. In 2007, the Food and Drug Administration (FDA) approved the medication for use in children and adolescents with those disorders, though the drug’s maker Janssen Pharmaceuticals had illegally marketed the medication to ... Read More

Sleeping pills, anti-anxiety drugs send more people to the ER

Bad reactions to anti-anxiety medications and sedatives send more people to the emergency room than any other drugs, according to a new study published in JAMA Psychiatry. The findings come from an analysis of medical records from 63 hospitals from 2009 to 2011. Researchers noted that most of the ER visits involved adverse side effects or overdoses, and nearly 20 percent of those resulted in hospitalizations. The biggest problem-maker was the sedative zolpidem tartrate, the active ingredient in the brand-name sleep aid Ambien. The drug is available in other brands as well as in generic. The drug accounted for nearly ... Read More

FDA finds cardiovascular risk with blood pressure medication used by diabetics is inconclusive

There is no clear evidence that the blood pressure medication olmesartan increases the risk of cardiovascular events in diabetic patients, the Food and Drug Administration (FDA) said in a Drug Safety Communication. The FDA began a safety review of olmesartan in 2010 after results from the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial raised cardiovascular risk concerns. The clinical trial was designed to see whether olmesartan could delay kidney damage in patients with type 2 diabetes. There was an unexpected finding of an increased risk of cardiovascular death in patients treated with olmesartan compared to patients given a ... Read More

Fresenius faces lawsuits for patent infringement

Fresenius Kabi, one of four business segments of the worldwide dialysis giant Fresenius Medical Care, was slapped with a lawsuit this week alleging that the company was violating patents for the cancer dug Isodax. Drug makers Celgene Corp. and Astellas Pharma claim that Fresenius Kabi filed an abbreviated new drug application with the Food and Drug Administration (FDA) to manufacture and sell a generic version of romidepsin for injection. The companies allege that doing so violates two active patents. Isodax is used to treat cutaneous T-cell lymphoma, a type of non-Hodgkin’s lymphoma, in patients who have received at least one ... Read More

Ranbaxy recalls 30,000 packages of generic OTC Claritin allergy pills

Ranbaxy is recalling 30,000 packs of its over-the-counter allergy medication due to problems with the packaging causing defects in the blister packs. The recall involves generic versions of Claritin’s slow-release pills with an added decongestant. Packages of the affected medicines are labeled with, “Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg,” and include 5-, 10-, and 15-count blister packs with an expiration date of September 2015. Affected drugs were sold at or under the labels of CVS, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid in ... Read More

Increasing number of foster care children prescribed antipsychotic drugs like Risperdal for ADHD

More and more children and teenagers in foster care are being prescribed antipsychotic drugs, such as Risperdal, to treat attention-deficit hyperactivity disorder (ADHD), according to a new study published online in the Journal of Child and Adolescent Psychopharmacology. Antipsychotic drugs are not approved by the Food and Drug Administration (FDA) to treat ADHD, though doctors have the authority to prescribe medications for so-called off-label uses. Many of these children and adolescents may not need the medication and by needlessly taking it may be exposed to potentially dangerous Risperdal side effects. The study involved data on more than 260,000 youths aged 2 ... Read More

Drug company sues FDA for dragging feet on testosterone gel marketing approval

Perrigo Israel Pharmaceuticals has filed a lawsuit against the Food and Drug Administration (FDA) alleging the company failed to update its records to show its approval of the company’s testosterone gel. Perrigo’s generic version of AbbVie’s AndroGel was approved by the FDA in February 2013. The company cannot market the product until the FDA registers it with Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. Under the FDA act, the agency is required to publish approved drugs with therapeutic equivalence information and update the Orange Book every 30 days. The lawsuit states that Perrigo made ... Read More

Short-term use, lower doses of Actos linked to increased bladder cancer risk

People who have been treated with the type 2 diabetes medication Actos (pioglitazone) for more than six months may be at greater risk of developing bladder cancer, even if they were on a low dose, according to a new study published in the Journal of Korean Medical Science and reported by Cancer Monthly. In 2011, studies showed long-term use (12 months or greater) of Actos increased the risk for bladder cancer. As a result, some countries banned the drug. The U.S. Food and Drug Administration (FDA) ordered that Actos and its generic equivalents include a warning on their safety labels ... Read More

FDA warns health care providers to carefully consider spinal catheters in patients using blood thinners

Physicians should carefully consider the timing of spinal catheter placement and removal in patients taking blood thinners such as Lovenox (enoxaparin), and delay dosing of the drugs for some time interval after the catheter is removed to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures, the Food and Drug Administration (FDA) advised. The new recommendations will be added to the labels of all anticoagulants known as low molecular weight heparins, which include the brand name Lovenox as well as generic versions of enoxaparin and similar products. Spinal column bleeding, ... Read More