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Food and Drug Administration 233 articles

FDA finds children’s drug manufacturer lax in quality control

Quality and security lapses identified during a Food and Drug Administration (FDA) investigation has led to the temporary suspension of production at Johnson & Johnson’s McNeill PPC drug manufacturing plant, located in Fort Washington, Penn., where children’s Tylenol, Motrin, Benadryl and Zyrtec were made. The investigation was followed by a recall of 1,500 lots of the brand name over-the-counter products distributed in the U.S. and internationally. The FDA says it is considering more actions against the company, including possible criminal penalties. “The quality issues that the FDA has observed, many of which we had recently identified in our own quality ... Read More

Sexual enhancer found to contain potentially dangerous ingredient

The Food and Drug Administration (FDA) is warning consumers not to use a sexual enhancement capsule distributed by Natural Wellness because the product contains an undeclared ingredient that may cause serious, life-threatening conditions for some populations. MasXtreme Capsules, sold in blister packs containing one capsule and distributed nationwide, have been found to contain the ingredient aildenafil which is close in structure to sildenafil and likely possesses a similar pharmacological and adverse event profile. The dietary supplement also was found to contain the drug phentolamine, an alpha-adrenergic blocker. Aildenafil may pose a threat to consumers because it may interact with nitrates ... Read More

FDA warns consumers against using ear candles

Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit. Manufacturers ... Read More

FDA cracks down on misleading drug promotions

Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008. “We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Thomas Abrams, head of the FDA’s Drug Marketing, Advertising and ... Read More

Southern Illinois district court to handle Yaz lawsuits

The Judicial Panel on Multidistrict Litigation in Washington D.C. has chosen the U.S. District Court in the Southern District of Illinois in East St. Louis to handle multidistrict litigation for what could be as many as 25,000 Yaz lawsuits. Chief Judge David Herndon will preside over the pre-trial proceedings, which have been filed by plaintiffs in all parts of the country against Bayer, the manufacturer of the popular oral contraceptive. Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege ... Read More

Jury awards man $5.5 million for shoulder injury caused by pain pump

Matthew Beale of Portland, Oregon, routinely participated in football, racquetball and golf, and he enjoyed coaching his son’s baseball teams. But a minor tear in his bicep tendon caused by throwing a football benched the 38-year-old father of four. His doctor recommended routine arthroscopic surgery during which he was prescribed an I-Flow pain pump to deliver pain medication directly to the wound site for up to 72 hours. However, the anesthetic that dripped from the pain pump into Beale’s shoulder joint killed the cells that create cartilage. Within months, Beale’s cartilage was completely destroyed, causing him so much pain he ... Read More

Surgeons discuss characteristics of chondrolysis caused by pain pumps

Characteristics of chondrolysis associated with intra-articular pain pumps after shoulder surgery was among the topics at the 2009 Annual Meeting of the American Academy of Orthopaedic Surgeons/ the American Association of Orthopaedic Surgeons. The discussion included Drs. Peter Thomas Scheffel, Jeremiah Clinton, Joseph Lynch, Winston J. Warme, and Frederick A. Matsen III, and was moderated by Drs. Carl J. Basamania and Guido Marra. The message centered on the need for surgeons and patients to be aware of chondrolysis as a potential complication of the infusion of local anesthetic after shoulder arthroscopy. A recent study published in The American Journal of ... Read More

FDA says it finds no Vytorin-cancer link, but unsure

The U.S. Food and Drug Administration announced today that it found no clear link between Merck’s blockbuster cholesterol drug Vytorin and increased risk of cancer, but it could not rule out the possibility that such a link exists. The agency reviewed data from three Vytorin trials, including the controversial SEAS trial results, which Merck had withheld from the public for 18 months as it aggressively marketed the drug. The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, ... Read More

December marks year anniversary of FDA OSP black box warning

One year ago this month, the Food and Drug Administration (FDA) issued a black box warning on a common type of laxative known as oral sodium phosphate, or OSP, available both over-the-counter and by prescription. After years of investigation, the FDA finally alerted health care providers and the public of the risk of a serious kidney injury known as acute phosphate nephropathy associated with the use of OSPs. Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. The black ... Read More

Ohio mother sues Bayer, alleging Yaz caused blood clot

A 30-year-old mother of three has joined the hundreds of women who have filed lawsuits against Bayer HealthCare, alleging that her use of the birth-control pill Yaz caused her to develop life-threatening blood clots in her left leg. The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg. Deep vein thrombosis ... Read More