Tagged Articles

safety communication 11 articles

FDA warns of next-day impairment with sleep aid Lunesta

The insomnia drug Lunesta (eszopiclone) can linger in users’ bloodstreams hours longer than intended, causing impairment of driving and other activities that require alertness, the Food and Drug Administration warned. The agency is recommending that starting doses be lowered to 1 mg at bedtime for both men and women. The drug labels for Lunesta and its generic counterparts will be updated to reflect the new warnings and recommended dosing. The new dosing is based on a study that found that the previously recommended dose of 3 mg can cause impairment of driving skills, memory and coordination that can last more ... Read More

FDA approves new silicone breast implant

Johnson & Johnson subsidiary Mentor has won Food and Drug Administration (FDA) approval to market a next-generation silicone breast implant. The MemoryShape breast implant uses a cross-linking gel that is designed to be firmer than previous implants. It is approved for women age 22 years or older. Silicone implants have traveled a rocky road in the medical device industry. In 2006, the FDA approved the first silicone breast implants – made by Mentor and Allergan – since banning silicone implants nearly 20 years earlier due to concerns that they caused illnesses in women who had them. That implant was approved ... Read More

Transvaginal mesh may cause or worsen autoimmune diseases

Transvaginal mesh (TVT) used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence has been associated with serious risks including mesh erosion, infections, and chronic pain. But the device may also leech dangerous toxins into the body causing or exacerbating autoimmune diseases, according to research compiled by TVT-NO!, a foundation for survivors of transvaginal mesh. “It has been noted (that) many women have been diagnosed with autoimmune diseases such as Lupus and Fibromyalgia after the insertion of TVT mesh,” the foundation warns on its website. Transvaginal mesh is a type of surgical mesh that ... Read More

FDA warns of seizure risk with MS drug

Ampyra (dalfampridine), a drug used to help people with multiple sclerosis (MS) walk, has been linked to seizures, according to a recent safety announcement by the Food and Drug Administration (FDA). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA also announced that it is updating the Ampyra drug label to clarify recommendations that kidney function should be checked in patients before starting the drug and be monitored at least annually while receiving Ampyra treatment. Additionally, patients who miss a dose should not take ... Read More

Women should consider risks with transvaginal mesh

Surgical mesh plays a significant role in the successful management of certain pelvic floor disorders but women should be aware of the problems that can occur with the mesh and take measures to minimize their risk, recommends Dr. Lesley K. Carr, urologist at Sunnybrook Health Sciences Centre and associate professor at the University of Toronto’s Department of Surgery. Transvaginal mesh is a device that is used to treat conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh is used to shore up organs that have dropped, or prolapsed, causing symptoms such as urinary incontinence, pain during intercourse, ... Read More

Actos, Avandia linked to eye disease that can cause blindness

Type 2 diabetes drugs Actos and Avandia have been caught up in a whirlwind of bad press in the past 12 months for being linked to life-threatening conditions such as bladder cancer and heart attacks, respectively. A new study shows that the drugs may cause even more problems – a type of eye disease that can lead to blindness. The study, presented at the American Diabetes Association annual meeting, found that people taking Actos or Avandia were 3 to 6 times more likely to develop diabetic macular edema, a condition in which the retina thickens and swells, caused by fluid ... Read More

FDA panel reviews safety studies on silicone breast implants

Consumer advocacy groups want the Food and Drug Administration (FDA) to ban the sale of silicone breast implants made by Johnson & Johnson because the safety of the products is in question. The National Organization for Women Foundation and the National Research Center for Women and Families argued their case to an FDA advisory panel, which was convened to review follow-up safety studies for silicone implants currently on the market. Women seeking breast implants for cosmetic reasons have two choices – saline and silicone. Approximately 400,000 breast enlargement or reconstruction procedures using either silicone or saline implants were performed in ... Read More

Blogger urges others injured by surgical mesh to file report

In December 2010, nine months after surgery where a surgical mesh “bladder sling” was implanted in her body to help with incontinence, Linda started a blog. It was the only way the 63-year-old widow could vent about the complications she experienced after surgery. Since then, she has received more surgeries, is in constant pain, and requires a walker for mobility. “When I started this blog it was out of my own anger and frustration because I researched mesh before I had the surgery,” she writes in an August 17, 2011 entry. “My doctor never once told me about a warning ... Read More

Doctors say avoid Actos unless no other diabetes treatments work

Many doctors think their patients should avoid the type 2 diabetes drug Actos because of the potential risk for bladder cancer, unless no other diabetes treatments help control their blood sugar levels, according to a report in the Sacramento Bee. The Food and Drug Administration (FDA) recently issued a safety communication warning doctors and patients with diabetes that it was reviewing data from new studies that showed the world’s best-selling diabetes drug, Actos,  could put users at risk for bladder cancer. Drug regulators in Europe have issued a similar warning, and officials in Germany and France have banned the drug ... Read More

Women file lawsuits against manufacturers of transvaginal mesh

Lisa Smith of Melbourne, Fla., says the mesh device implanted in her vagina to help with a common condition known as pelvic organ prolapse felt like barbed wire. Even now that it has been removed, the pain lingers. Smith is one of about 300 women in 34 states who have filed a lawsuit against the manufacturers of transvaginal mesh devices. The surgical mesh is designed to repair pelvic floor disorders, conditions that affect an estimated 30 to 50 percent of women older than 50. In pelvic organ prolapse, pelvic muscles and tissues such as the bladder, the top of the ... Read More