Articles Tagged with FDA

medicine-200.jpgDisposal of unused drugs, dangerous diet supplements and contaminated tattoo ink led the health and safety topics which most interested consumers in 2012.

The Food and Drug Administration (FDA) reported these were among the top 10 most read topics on its Consumer Updates, which can be found on its website and are distributed through e-mail subscriptions.

How to Dispose of Unused Medicines. Consumers should follow any directions on the label for proper disposal. Otherwise, most prescription drugs can be thrown in the trash, unless the directions specify they should be flushed down the toilet. Drugs thrown in the trash should be mixed with substances such as coffee grinds, kitty litter or leftover food. Consumers should also call their city or municipal office and ask about community drug take-back programs that allow the public to bring unused drugs to a central location for safe disposal. Read more.

pills-175.jpgAfter years of close monitoring and label changes for Multaq, the Food and Drug Administration (FDA) has issued a new warning that the heart drug places some patients at an increased risk for serious cardiac events including death.

Multaq is used to treat various conditions, including patients with permanent Atrial Fibrillation (permanent AF). This is the most serious form of AF, which is an abnormal heart rhythm. The two other types are paroxysmal AF and persistent AF.

Permanent AF is a chronic condition in which sinus rhythm cannot be sustained despite treatment.

The FDA issued its Dec. 19, 2011 safety notification based on its monitoring of a 10-year study. In the communication, the FDA stated Multaq doubles the rate of cardiovascular death, stroke and heart failure in patients with permanent AF. The FDA advised healthcare professionals to:

  • Not prescribe Mutlaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF).
  • Monitor heart rhythm by electrocardiogram at least once every three months.
  • If the patient is in permanent AF, Multaq should be stopped or the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF.
  • Patients prescribed Multaq should receive antithrombatic therapy.

The study the FDA acted on was called called the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS). The study was stopped early in July 2011. The FDA said it will release more information as it becomes available.

Multaq Background
Dronedarone is the generic name for Multaq. It was approved by the FDA in 2009 to treat several conditions, including permanent AF. Manufactured by Sanof-Aventis, the drug has been prescribed to 500,000 people around the world.

Since 2009, Multaq has been subject to several FDA actions, including in 2010 a revised warning noting cases of worsening heart failure in some patients. In February 2011, the FDA changed the warning label to state that Multaq should be discontinued if liver damage is suspected.

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Following thousands of reports about serious injuries among women, a Food and Drug Administration (FDA) panel will begin examining the safety of surgical mesh on Sept. 8 and 9.

Surgical mesh is implanted during transvaginal mesh surgery, the treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The procedure is performed to repair weak or stretched vaginal tissue, often after childbirth.

The panel’s review comes almost two months after the FDA’s July 13 public safety advisory on surgical mesh and as special interests step into the debate about a possible surgical mesh recall.

In the July 13 advisory, the FDA said transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA’s finding was based on a review of scientific literature published between 2006 and 2011.

Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.

The most prevalent complaint was mesh erosion within the body, but other injuries included bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. Remedies include corrective surgery, hospitalization and intensive follow-up medical treatment.

On August 25, 2011, Public Citizen, a Washington D.C.-based consumer advocacy group, called for a recall of all non-absorbable synthetic material used in transvaginal mesh surgery. It also wants a reclassification of the approval process for new surgical mesh products.

The same day, a coalition of 600 pelvic surgeons submitted the FDA a letter challenging its findings about the risk for complications during transvaginal mesh surgery. The letter was obtained by the CommonHealth medical website. Among their challenges, the surgeons argued mesh erosion is not a major complication.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.

Nine companies manufacture transvaginal mesh products, including Boston Scientific and Johnson & Johnson. Bloomberg News reported one recommendation from the FDA staff administration would require the manufacturers to submit additional safety data to regulators.

The FDA cleared 85 mesh devices to treat pelvic organ prolapse from 1992 to 2010.
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