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safety risks 21 articles

Essure birth control device is Bayer’s latest legal woe

Gabriella Avina was one of the first women to be implanted with the Essure non-surgical permanent birth control method. She had participated in clinical trials to test the safety and effectiveness of the implant even before it was approved in 2002 for sale in the United States. Avina was pleased with the contraceptive implant at first, and even worked for Conceptus, Inc., the company that manufactured the device, explaining to women how Essure worked when it first came on the market. Now, Avina says, she was wrong to advocate for Essure. Essure is a small, metal and polyester coil that is ... Read More

FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

Waistline measurement can indicate type 2 diabetes risk

Want to know if you are at risk for type 2 diabetes? Then whip out your tape measure, says Public Health England. Waistlines larger than 40 inches in men or 35 inches in women indicate a “very high risk” of developing the chronic disease, the agency warns. Men with a 40-inch waist are five times more likely to develop type 2 diabetes and women with 35-inch waistlines were three times more likely to develop the disease compared to those with slimmer waistlines. Even waistlines three to four inches smaller than 40 or 35 inches for men and women, respectively, puts ... Read More

FDA delays decision on diet pill based on heart risk evaluation

The Food and Drug Administration (FDA) has delayed its decision by three months on the new diet pill contrave in order to reach an agreement with drug company Orexigen Therapeutics regarding post-marketing obligations related to the evaluation of cardiovascular risks associated with the drug. Orexigen and the FDA are currently in talks about the package insert and other post-marketing requirements. The FDA had rejected the drug in 2011, saying it needed more studies to put to rest concerns about heart risks. Orexigen came back nearly three years later with an analysis involving 8,900 patients showing patients taking contrave did not ... Read More

Study links testosterone therapy to brain damage

Testosterone replacement therapy may cause brain damage in Caucasian men, a new study suggests, adding yet another strike against the increasingly popular hormone treatment. Testosterone treatments are approved to boost levels of the hormone in men experiencing symptoms of so-called Low-T, such as a diminished sex drive, fatigue, weight gain and muscle loss. In recent years, prescriptions for testosterone supplements have skyrocketed in the United States, leading many experts to worry that the drug is being given to men who don’t necessarily need it. In its natural form, testosterone helps protect the brain against free radicals, which can damage brain ... Read More

Drug to treat rare disorders recalled for third time since August

Alexion Pharmaceuticals has issued the third recall since August of its sole approved drug Soliris after visible particles were seen in some vials during periodic testing. If injected, the particles could pose safety risks to patients in two general areas – first it could cause immune reaction and blood clots. Secondly, particles could cause blockage of blood flow in vessels, which could be life threatening. Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening blood disease; and patients with atypical hemolytic uremic syndrome, (aHUS), a rare disease in children that causes ... Read More

Fresenius recalls Parkinson’s drug due to contamination of glass particles

Fresenius Kabi is recalling one of its injectable drugs because of potential contamination with glass particles. The recall affects four lots of benztropine mesylate, a drug to treat the symptoms of Parkinson’s disease and tremors caused by other medical problems or drugs. In some cases, the glass particles in the vials of the drug have been visible. The warning to customers said that in some cases if the glass particles split into layers, the glass particulate can be too small for the naked eye to see. No adverse events or customer complaints have been reported to date, however if the ... Read More

Patients, consumers should be aware of potential risks with at-home medical devices

Patients and consumers are using medical devices more often at home and not just in health care facilities. These home-use medical devices were once designed only to keep a person alive, but now they’re designed to keep people as independent as possible. However, the Food and Drug Administration (FDA) does have concerns that many people are – quite literally – left to their own devices. They may not fully know how to operate the devices or understand the safety risks. In some cases, there have been serious and even fatal problems with medical devices used at home. For example, one ... Read More

First Yaz lawsuit ordered to mediation for potential settlement

The first of more than 10,000 lawsuits against Bayer over its birth control pills Yaz and Yasmin won’t go to trial this week as planned because a judge appointed a mediator in hopes of settling the case. The lawsuit accused Bayer of misleading women about the safety risks associated with its oral contraceptives. U.S. District Judge David Herndon ordered Bayer and lawyers for the defendant to meet with mediator Stephen Saltzburg, a Gerorge Washington University law professor, to explore a possible settlement. Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. New studies ... Read More

Lawyers investigating heart problems associated with Darvocet, Darvon

Last fall, at the request of the Food and Drug Administration (FD), Xanodyne Pharmaceuticals agreed to withdraw its popular prescription painkillers Darvon and Darvocet from the United States market because new clinical data showed that the drugs’ active ingredient propoxyphene put patients at risk of very serious or even fatal heart rhythm abnormalities. This new information led the FDA to the conclusion that drug’s effectiveness in reducing pain was no longer enough to outweigh the drug’s serious potential heart risks, and thus, all drugs containing propoxyphene were withdrawn from the market. But on two separate occasions during the 54 years ... Read More