Tagged Articles

severe pain 16 articles

Painkiller recalled due to improper expiration dates on label

Sagent Pharmaceuticals has issued a nationwide recall on a painkiller. Three lots of Ketorolac Tromethamine Injection, a nonsteroidial anti-inflammatory drug, were recalled because the medications were printed with the incorrect expiration date. The labeled date is longer than the known stability of the drug. Ketorolac Tromethamine is used short-term in postoperative patients to treat moderately severe acute pain that requires analgesia in patients already using opioid painkillers. The affected lots include 30mg/mL single-dose vials with the NDC numbers 25021-701-01 and 25021-701-02. Affected lot numbers include MP5021, MP5024, and MP5025 and were distributed to hospitals, wholesalers and distributors across the country ... Read More

Type 2 diabetes drug adds new warning for serious injection site reactions

New information has been added to the safety label of the injectable type 2 diabetes drug Bydureon to include a new warning that some people using the medication have experienced serious injection-site reactions, some of which have required surgical intervention. The new Injection-Site Reaction information was added to both the Warnings & Precautions and the Adverse Events sections of the medication, and new information was added to the patient counseling information and medication guide. Injection-site reactions reported include abscess, cellutitis and necrosis, with or without bumps, or nodules. Patients are advised to contact their health care provider immediately if they experience ... Read More

FDA approves pure form of painkiller hydrocodone, deemed stronger than Vicodin

Just days after the Food and Drug Administration (FDA) proposed stricter rules for drugs containing hydrocodone – such as Lortab and Vicodin – to help curb the growing epidemic of prescription drug abuse, the agency announced that it has approved a purer form of hydrocodone that is even stronger than other drugs in its class. The FDA approved Zohydro ER to treat pain severe enough to require around-the-clock, long-term treatment. The drug is approved for patients for whom alternative treatment has proved inadequate or ineffective. The FDA did require the drug’s maker, Zogenix, to conduct post marketing studies for Zohydro ER ... Read More

FDA requiring visible fentanyl warning on Duragesic pain patches

Powerful narcotic fentanyl pain patches not only will have more visible warnings about deaths related to accidental exposure, but they were also added to the list of about 30 prescription drugs that should be disposed of by flushing down the toilet. Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, will update the label on it Duragesic pain patch, which contains fentanyl. Fentanyl is a strong opioid medication used to treat severe, ongoing pain that cannot be controlled by other medications. The drug comes in various forms including a nasal spray and injection. Only the pain patches will carry the new, ... Read More

FDA orders Fentanyl patches add more visible warnings of deaths from accidental exposure

The Food and Drug Administration (FDA) is requiring makers of Duragesic (fentanyl) pain patches to make warnings of deaths from accidental exposure to the patches more visible to remind patients and caregivers how dangerous the patches can be if they are not disposed of properly. Fentanyl is a powerful narcotic medication that is used to treat severe, ongoing pain that cannot be controlled with other medications. The drug is available in various forms including injection and nasal spray. The warning label requirement applies only to the transdermal patch, which is applied to the skin. The patches contain the medication and ... Read More

Transvaginal mesh manufacturer’s stock drops in light of personal injury lawsuits

Humlebaek, Denmark-based transvaginal mesh manufacturer Coloplast A/S said last week that it didn’t expect lawsuits waged against the company in the United States would have “significant financial impact,” but investors are skeptical. The company’s stock fell as much as 1.8 percent – the lowest since May 2 – making it the worst performing in the benchmark OMX Copenhagen index. The blow comes just a week after a jury in the first federal transvaginal mesh trial – against competitor C.R. Bard Inc. – ordered the manufacturer to pay $2 million in damages to a woman who claimed Bard’s transvaginal mesh device ... Read More

Transvaginal mesh company settles lawsuit just before trial begins

Just minutes before a transvaginal mesh bellwether case in multidistrict litigation (MDL) was to begin, the judge announced that medical device manufacturer C.R. Bard had reached a settlement with defendants. The agreement comes less than a week after the company was ordered to pay $2 million in the first bellwether trial. The terms of the settlement are confidential, but it represents just a drop in the bucket of litigation facing the medical device company related to its Avaulta transvaginal mesh implants. The lawsuits allege the mesh, which is used to treat pelvic organ prolapse and stress urinary incontinence, caused internal injuries ... Read More

Childbirth a leading cause of pelvic organ prolapse

Women who give birth vaginally are more likely to develop pelvic organ prolapse during the first year after childbirth than women who have cesarean sections, according to a study published online in the British Journal of Obstetrics and Gynecology. Researchers noted that during the labor and delivery process, the pelvic floor relaxes but does not recover its former support during the year after birth. This relaxing of the pelvic muscles does not occur in women who do not labor and have C-sections. Women who labor but ultimately have a C-section are still at risk for pelvic organ prolapse. Pelvic organ ... Read More

One-third of women who undergo transvaginal mesh surgeries have complications

A third of patients who undergo surgery to repair common pelvic floor disorders experience complications, according to a new study published in the Journal of the American Medical Association. The surgery, called an abdominal sacrocolpopexy, is used to correct pelvic organ prolapse and stress urinary incontinence. It involves the vaginal insertion of surgical mesh, which is used to hold up organs such as the bladder, rectum or uterus that have fallen out of place due to childbirth, age or obesity. About 25 percent of women suffer from these conditions and about 11 to 19 percent undergo sacrocolpopexy to correct it. Though ... Read More

Women file lawsuits against makers of transvaginal mesh

Lori Eggenberg thought the surgery she was having to correct urinary incontinence was the newest, most advanced, minimally invasive procedure available. Her doctor used transvaginal mesh to lift up her bladder. It turned out to be her worst nightmare. Lori’s bladder sling, as the mesh is sometimes called, embedded in the tissue causing severe pain. Travaginal mesh is a type of surgical mesh that in recent years has been used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The mesh is inserted through the vagina to hold up organs that have dropped due ... Read More