Tagged Articles

Xenical 16 articles

Xenical, Alli linked to neuropsychiatric side effects

The Food and Drug Administration (FDA) is reviewing cases of neuropsychiatric adverse events associated with use of Alli and Xenical capsules used for weight loss. Both Alli and Xenical contain the active ingredient orlistat. Alli is sold over-the-counter. Xenical is available by prescription only. The cases were identified in the quarterly (January-March 2017) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). The appearance of a drug on FAERS does not mean that the FDA has concluded that the drug causes the mentioned side effect. It means that the FDA has identified a ... Read More

FDA approves Belviq, first weight loss drug in more than a decade

A new prescription weight-loss pill has been approved by the Food and Drug Administration (FDA), making it the first diet pill to hit the U.S. market in more than a decade. Arena Pharmaceuticals Belviq (lorcasserin) was deemed safe enough to get a nod by drug regulators, though the agency says studies showed only modest weight loss in clinical trials. Belviq was approved for adults who are obese or overweight with at least one medical complication such as diabetes or high cholesterol. The drug should be used with a healthy diet and exercise. The FDA first rejected Belviq in 2010 after ... Read More

Roche questioned about unreported possible drug side effects, deaths

Roche, maker of drugs such as the cancer drug Avastin, flu medicine Tamiflu, antianxiety drug Klonopin, and the diet pill Xenical, is being investigated by European drug regulators because of potential deficiencies in the way the drug company reported possible side effects in patients in the United States. The European Medicines Agency identified the problems during a routine inspection of Roche, during which they found about 80,000 reports of possible side effects in drugs sold in the U.S. that had not been followed up on to determine if they were actual adverse reactions that should be reported to drug authorities. The ... Read More

FDA delays vote on experimental diet drug Qnexa

Approval for the experimental weight loss drug Qnexa has been pushed back another three months, paving the way for other drugs to stretch ahead in the race for the first diet pill in 13 years to be granted marketing rights in the United States. The Food and Drug Administration (FDA) pushed back the target date for approval to allow time to review a new safety plan submitted by drug maker Vivus Inc. These plans often include information that explains side effects and safety risks. Side effects reported with Qnexa include birth defects, heart palpitations, suicidal thoughts, and memory lapses. Vivus ... Read More

FDA advises diet drug makers to assess heart risks

Pharmaceutical companies who develop weight loss drugs need to study their medications to determine heart risks before seeking approval from health regulators, the Food and Drug Administration (FDA) said in a report released this week. Three drug companies are vying to get approval for what would be the first diet pills to hit the market in 13 years. Vivus’s drug Qnexa will be reviewed by an FDA panel in April, and Arena’s medication lorcasserin will be reviewed in May. Drug company Orexigen agreed in September to conduct safety studies on its diet pill, Contrave. Contrave hit a snag with FDA ... Read More

Diet pill indicated as contributing cause of Bubba Smith’s death

Results from an autopsy indicate the diet pill phentermine contributed to the death of Bubba Smith, the towering all-pro football player-turned-actor and commercial spokesman. Smith was also found to have heart disease and high blood pressure. He was 66. The autopsy report listed as a contributing cause of death acute phentermine intoxication, a condition that can cause the heart to beat irregularly and the body to overheat until the person collapses. Phentermine was one ingredient in the diet pill combination “Fen-Phen,” which was pulled from the market after it was shown to cause serious heart risks. Fenfluramine – the “fen” ... Read More

FDA to consider diet pill with birth defects warning

California-based drug company Vivus Inc. is hoping to win Food and Drug Administration (FDA) approval for its experimental diet drug Qnexa, after it was rejected last October because of concerns that it may cause birth defects and increased heart rate. Vivus has resubmitted Qnexa as a treatment for obese or overweight patients with weight-related disorders such as high blood pressure or diabetes with a new warning that the drug should not be used by women of childbearing age. In addition to the new warning label, the resubmission also includes a risk evaluation and mitigation strategy. An FDA advisory panel is ... Read More

Popular weight-loss supplements pose injury and death risks, consumer group warns

The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately, warns Public Citizen, a national non-profit consumer advocacy group based in Washington D.C. The group has petitioned the Food and Drug Administration (FDA) for a ban of the popular drugs, citing evidence that they can cause severe, life-threatening injury to liver, pancreas, and kidneys. Alli and Xenical are forms of orlistat. Xenical contains 120 milligrams (mgs), while Alli, which is available without a prescription, contains half the amount of orlistat. Public Citizen says that the risks of serious injury far outweigh the drugs’ ... Read More

Public Citizen takes aim at diet pills Alli, Xenical

The consumer watchdog group that nearly four decades ago first warned the Food and Drug Administration (FDA) that the painkiller Darvocet should be banned from the market because it was killing people, has taken aim at a diet pill. Public Citizen has petitioned the FDA to take a closer look at side effects caused by orlistate, the weight loss drug sold over-the-counter under the brand name Alli and by prescription in higher doses under the name Xenical. The group says it pored through the FDA’s public database of serious side effects to drugs and identified 47 cases of acute pancreatitis ... Read More

Public Citizen raised flags about Darvocet, now warns of Alli, Xenical

Consumer watchdog group Public Citizen was the first to raise concerns about the safety of propoxyphene, the active ingredient in the brand-name drugs Darvocet and Darvon. The group petitioned the Food and Drug Administration (FDA) twice since the prescription painkiller was introduced more than 50 years ago. Public Citizen claimed the drug had a sketchy track record for efficacy and that patients were needlessly dying from accidental overdoses while taking the drug. The FDA opted to keep propoxyphene-containing drugs on the market, but did agree to put stronger warnings on the product’s safety label. Still, Public Citizen urged, it was ... Read More