Tagged Articles

Europe 20 articles

Europe approves new combination diabetes treatment despite bladder cancer concerns

European drug regulators have approved AstraZeneca and Bristol-Myers Squibb’s combination type 2 diabetes drug Xigduo, making it the first treatment to combine a SGLT2 inhibitor with metformin. Xigduo is a combination of the widely used diabetes drug metformin and dapagliflozin, a new diabetes treatment sold in Europe as Forxiga. It was approved earlier this month by the U.S. Food and Drug Administration (FDA) under the name Farxiga. Dapagliflozin is in a new class of diabetes drugs known as SGLT2 inhibitors. Johnson & Johnson’s SGLT2 Invokana was approved in the U.S. in 2013. Other SGLT2 drugs are currently in development. The ... Read More

Two strangulation incidents, one death causes IKEA recall of 23 million children’s lamps worldwide

IKEA, the world’s largest furniture retailer, has recently announced a tremendously significant recall of nearly 23 million children’s wall-mounted lamps worldwide. In the United States alone, 2.9 million children’s lamps have been recalled by IKEA and the Consumer Product Safety Commission (CSPC). Two separate incidents, both taking place in Europe, occurred involving the recalled children’s lamp – one involving the death of a 16-month-old child strangled by the lamp’s cord and another concerning a 15-month-old child nearly becoming strangled on the lamp’s cord. Each incident involved the same issue of the cord being pulled in the crib by the infants, ... Read More

European Parliament considers stronger medical device oversight to better ensure patient safety

Europen Parliament is considering adopting a proposal that would give European drug and medical device regulators more control over medical devices, and require high-risk devices to undergo an approval process before they reach the market. In both Europe and the United States, most medical devices are cleared swiftly for marketing if they can prove they are similar to products already on the market. This has raised safety concerns in the past in both countries, especially after high-profile recalls and safety advisories including the worldwide recall of Johnson & Johnson’s DePuy Orthopaedic ASR metal-on-metal hip replacement system. The devices were granted ... Read More

Johnson & Johnson recalls 32 million packs of birth control pills

Johnson & Johnson has issued another massive recall, this time on 32 million packages of birth control pills because of a flaw that could cause unplanned pregnancies. The oral contraceptives are sold in 43 countries around the world, but not in the United States. This recall is one of about 40 the consumer health product giant has issued on everything from over-the-counter medications to artificial hips since 2009. The recall was initiated because quality tests performed on the drugs showed one of the two hormones in the pills was releasing slower than it should. The company said the risk of ... Read More

European drug advisors reject Qsiva (Qsymia) diet drug based on safety concerns

Advisors for the European Union’s health agency has again recommended against approving the new weight loss drug Qsiva, made by Vivus Inc. The Committee for Medicinal Products for Human Use raised concerns about the cardiovascular safety of the drug, saying it would need more data proving its safety before it would reconsider its rejection. Qsiva is a combination of two FDA-approved drugs – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Phentermine was part of the fen-phen diet drug cocktail that was popular in the 1990s, but was pulled from the market after studies showed the ... Read More

Merck suspends sales of cholesterol drug Tredaptive due to serious adverse reactions

Sales of the cholesterol drug Tredaptive are being suspended after initial results from a study showed that the drug was not effective at lowering cholesterol and could increase the risk for serious side effects. Drug maker Merck & Co. is also asking doctors to stop writing prescriptions for the tablets. Tredaptive is not approved in the United States, but it has been approved in about 70 other countries, and is sold in about 40 countries, including Europe. It is also sold under the brand names Pelzont in Italy, Trevaclyn in Italy and Portugal, and Cordaptive in other markets around the ... Read More

Company apologizes for birth defects caused by drug given to pregnant women

German drug maker Gruenenthal Group is apologizing to women who took its morning sickness medication Thalidomide in the 1950s and 1960s, and to their children who suffered congenital birth defects as a result. The apology comes 50 years after the drug was pulled off the market for causing babies to be born with shortened arms and legs or with no limbs at all. “We ask that you regard our long silence as a sign of the shock that your fate caused in us,” said Harald Stock, Gruenenthal Group’s chief executive, during an unveiling of a statute in the drug company’s ... Read More

Gardasil distribution stalled in France pending government-ordered study

The distribution of Merck’s human papillomavirus (HPV) vaccine Gardasil has been halted in France, where a government-appointed group of immunologists and other researchers has been formed to determine if the benefits of the vaccine are worth the risks. As in the United States, Gardasil has become a “thorny subject” in France, with many parents suspicious of the vaccine’s benefits and fearful of its risks, according to France’s Le Point. Data pulled from the U.S. Vaccine Adverse Event Reporting System (VAERS) shows that from the time Gardasil was introduced in 2006 until September 15, 2011, 20,096 adverse events following the vaccine ... Read More

Counterfeit cancer drug traced back to distributors in Egypt

Counterfeit vials of the cancer drug Avastin that were found circulating in Europe and the United States earlier this month contain salt, starch and a variety of chemicals, but none of the active ingredient bevacizumab that fights cancer. Avastin is an injectable medicine made by Swiss drug maker Roche. It is administered to patients at clinics, hospitals and doctors’ offices. It is used to treat various forms of cancer including colon, kidney, brain and lung cancers. Avastin made headlines recently when the Food and Drug Administration (FDA) pulled the drug’s breast cancer indication because it was not proven safe or ... Read More

New drug could offer more treatment options for type 2 diabetes

French drug maker Sanofi has won approval from European authorities to market the type 2 diabetes drug lixisenatide, which will be sold under the brand name Lyxumia. The Food and Drug Administration (FDA) is currently reviewing the medication for sale in the United States. Lyxumia aims to give more – and potentially safer – treatment options for patients with type 2 diabetes. Lyxumia is in the GLP-1 class of drugs, which boost insulin in the body at the time when level of glucose is extremely high. Clinical studies pairing the once-daily drug with the insulin drug Lantus in patients with ... Read More