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Friday September 10, 2010

Posts Tagged ‘fda’

FDA to Add Strictest Warnings to Bowel-Cleansing Drugs

Thursday, December 11th, 2008

Two prescription bowel-cleansing drugs commonly taken before colonoscopies will receive the sternest safety warnings available after nearly two dozen patients reported suffering severe kidney damage after taking the drugs, the Food and Drug Administration said.

The drugs, Visicol and OsmoPrep, are oral tablets made by Salix Pharmaceuticals. The FDA has received more than 20 reports of kidney failure in patients taking the tablets, known as oral phosphate products.

The drugs will now have new boxed warnings added to their packaging stating they are to be used with caution in patients older than 55, those who suffer from dehydration and kidney diseases, and those who are taking kidney medications.

The FDA first warned doctors and patients about potential kidney risks with the medications in 2006. A petition submitted to the agency last September called on regulators to place a boxed warning on the drugs.

Federal product safety regulators also are eyeing several brands of over-the-counter bowel cleansers, which are most often not taken under the direction or supervision of a physician and are more likely to be abused or used improperly than prescription drugs, the FDA said.

While many people use the drugs without any side effect, over-the-counter brands, including Fleet Phospho-soda, made by C.B. Fleet Company Inc., can result in serious kidney damage if not taken properly, officials said.

Glaucoma Drug Boosts Eyelashes, FDA Panel Says

Friday, December 5th, 2008

A glaucoma drug appears to have another use: Making eyelashes longer, darker, and fuller.

Allergan, the maker of the blockbuster cosmetic drug Botox, wants the Food and Drug Administration to approve its Lumigan glaucoma drug for use as an eyelash booster. The drug maker got preliminary approval this week from an FDA advisory panel, which voted to allow Allergan to move forward with company trials to determine whether the drug is safe for use on eye lashes.

The FDA is not required to follow its panel’s recommendation, although it most often does. The agency could approve the new use of the drug sometime in 2009, officials said.

Allergan has said it plans to market the eyelash drug under the brand name Latisse. In company trials, the drug has been shown to grow, darken, and thicken eyelashes with daily use of the liquid formula applied directly to the lashes. The company estimates Latisse could earn Allergan about $500 million a year in sales.

Traces of Melamine Found in U.S. Infant Formula

Wednesday, November 26th, 2008

The toxic industrial chemical melamine, which has been blamed for four deaths and 50,000 injuries in China since it was found in infant formula and other products in that country, has now turned up in a leading American brand of infant formula, the Food and Drug Administration said.

Melamine is an industrial chemical used in the manufacture of can liners, flame retardant, cleaning products, fertilizers, and pesticides. Officials have said Chinese manufacturers may have intentionally added the chemical to infant formula and other products because the chemical can mimic protein and defeat food quality-control testing.

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Dermal Fillers Cause Serious Problems, FDA Says

Friday, November 14th, 2008

Wrinkle-fighting dermal fillers like Juvederm, Restylane, Radiesse, and Perlane can have serious and unexpected health complications in users who are looking to shave years off their appearance, the U.S. Food and Drug Administration said.

The agency said it has received 930 reports of health problems caused by the cosmetic products in the past six years. The problems included facial palsy (paralysis), disfigurement, severe allergic reactions, swelling, and other complications.

Unlike Botox, which is a form of purified botulism and paralyzes facial muscles to prevent winkles, dermal fillers have the effect of plumping up the skin and filling in wrinkles and creases, particularly around the eyes, nose, and mouth. Dermal fillers have risen in popularity in recent years, the FDA said.

The FDA said it is considering whether to order changes to the labels of dermal fillers to reflect the risk of injuries.

Double-Dose Fears Prompt Heart Drug Recall

Tuesday, November 11th, 2008

Drug-maker Ethex Corp. has announced a recall of five of its generic heart medications due to concerns some of the pills may contain life-threatening double-doses of active ingredients. Overdoses of the drugs could cause deadly heart arrhythmia, low blood pressure, respiratory failure, and other serious complications. The drug recall is being initiated as a precautionary move and no patient deaths or injuries have been reported, the Food and Drug Administration said.

The generic drugs involved in the recall are:

• Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg

• Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg

• Morphine Sulfate Extended Release Tablets 15 mg

• Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg

• Dextroamphetamine Sulfate Tablets 10 mg

The lots involved in the recall were all shipped prior to May 22, 2008, officials said.

Patients who have in their possession drugs involved in the recall are urged to contact their healthcare provider.

FDA Warns About Injuries from Surgical Mesh

Wednesday, October 22nd, 2008

A type of surgical mesh used in procedures for the treatment of severe incontinence, cases of prolapsed uterus, and other women’s health problems has been linked to serious, but rare, complications, according to the U.S. Food and Drug Administration.

Since 2005, more than 1,000 reports of injuries have been received regarding several types of surgical mesh used to repair pelvic organ prolapsed and stress urinary incontinence. The mesh, inserted into the vagina, can cause infection, pain including during sexual intercourse, and urinary problems, officials said.

A pelvic organ prolapse occurs when the bladder, bowel, or rectum pushes against the walls of the vagina. Muscles that hold pelvic organs in place may become weakened or stretched by childbirth or surgery, allowing them to move out of place.

Stress urinary incontinence is a type of incontinence caused by leakage of urine during moments of physical stress.

Some patients who used surgical mesh in their surgeries have had to undergo repeated procedures to remove the mesh from their bodies. Nine different manufacturers of the surgical mesh have been identified in the complaints, officials said.

Doctors Call on FDA To Keep Cold Medicines Away From Children

Thursday, October 2nd, 2008

Over-the-counter cough and cold medicines have unproven results and may be dangerous for young children, a group of doctors and consumer advocates said. The group is urging the U.S. Food and Drug Administration to ban the sale of popular products such as Dimetapp and NyQuil for use in children ages 2 to 6.

The group of medical experts from various organizations also targeted the brands Triaminic, Tylenol, and PediaCare as being unsuitable for use in young children.

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Chinese-Made Instant Coffee and Tea Recalled Over Contamination Fears

Friday, September 26th, 2008

The U.S. Food and Drug Administration is warning consumers not to drink Mr. Brown instant coffee and milk tea products made in China because they may contain a potentially deadly chemical additive.

Melamine, a toxic chemical used in the manufacturing of plastics that can be used to cheat food quality checks by imitating food protein, may be found in the beverages. The chemical has already been detected in Chinese-made candy, buns, and carton milk, officials said.

The coffee and tea products being recalled are Mr. Brown Mandheling Blend Instant Coffee (3-in-1); Mr. Brown Arabica Instant Coffee (3-in-1); Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1); Mr. Brown Caramel Macchiato Instant Coffee (3-in-1); Mr. Brown French Vanilla Instant Coffee (3-in-1); Mr. Brown Mandhling Blend instant Coffee (2-in-1); and Mr. Brown Milk Tea (3-in-1).

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FDA Looking Into Link Between Anemia Drug and Deaths

Friday, September 26th, 2008

The U.S. Food and Drug Administration is investigating whether a Johnson & Johnson anemia drug increases the chance of death in stroke patients.

A German medical study found that 16 percent of stroke patients treated with the drug, Eprex, died within three months of taking the drug, compared to just nine percent who died after receiving a placebo.  The study was designed to test whether Eprex might improve brain function in stroke patients, which is an unapproved use of the drug. Patients in the study were given relatively high doses of Eprex for three days and most were not anemic, the FDA said.

Eprex (generic epoetin alfa) is also sold by Johnson & Johnson under the name Procrit. Amgen Inc. sells the drug under the brand name Epogen.

After German researchers alerted the FDA about the deaths in their study, the FDA said it was reviewing the study’s findings.

Boston Scientific Earns FDA Approval for Next Generation of Drug-Eluting Stents

Thursday, September 25th, 2008

Boston Scientific Corp. has won U.S. regulatory approval for its next generation drug-eluting stents, the company announced.

The company plans to immediately launch its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System, the only drug-eluting stent on the U.S. market for use in vessels as small as 2.25 mm in diameter.

Stents are tiny wire-mesh tubes that are inserted into diseased arteries to prop them open after they have been surgically cleared of blockages.

The use of stents has decreased in recent years amid concerns that the devices could lead to late stent thrombosis, a small but deadly risk of blood clots forming inside the stent a year or more after implantation.

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