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WASHINGTON, Nov 14, 2008 /PRNewswire-USNewswire via COMTEX/ — The United States is seeking a permanent injunction to bar Actavis Totowa LLC, and Actavis Inc. and two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced today.
Actavis Totowa is a drug manufacturer located in New Jersey. Actavis Inc. is the United States manufacturing division of Actavis Group hf, an international generic pharmaceutical company located in Iceland, and the direct parent of Actavis Totowa. The two officers are Sigurdur Oli Olafsson, the Executive Chairman of Actavis Inc., and Douglas Boothe, the President and CEO of Actavis Totowa.
According to the complaint, The Food and Drug Administration (FDA) conducted five inspections of Actavis Totowa’s facilities over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. FDA also found that the company continued to manufacturer and distribute unapproved new drug products.
Under the FDCA, drugs are adulterated if they were not manufactured in compliance with Good Manufacturing Practice requirements; and they are misbranded if they are unapproved by the FDA.
During its most recent inspection this year, FDA found that Actavis Totowa’s failure to comply with the Good Manufacturing Practice requirements resulted in, among other things, the company’s release of Digoxin tablets to the market after it had discovered that some tablets from the same production batch were double thick and, thus, double potent. Double dose Digoxin tablets can cause digitalis toxicity and result in cardiac instability, bradycardia and death among other things.
Recently, the defendants informed FDA that they would like to restart manufacturing drug products. However, Actavis has not demonstrated to FDA that it can do this in compliance with the Good Manufacturing Practice requirements.
“FDA and the Justice Department are committed to ensuring that drugs sold in the United States are safe and effective,” said Gregory Katsas, Assistant Attorney General for the Justice Department’s Civil Division. “As part of this commitment, we have and will continue to file injunction actions to enforce strict compliance with Good Manufacturing Practice requirements.”
SOURCE U.S. Department of Justice

On November 5, 2008 the FDA announced a nationwide recall of mislabeled ReliOn Insulin Syringes.
People with diabetes who use ReliOn insulin syringes should check their syringe package because of an important recall.

The FDA news release states:

“The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death”

An overdose of insulin can cause low blood sugar. Symptoms can include:
* Confusion
* Shaky hands and legs
* Sweating
* Appearance of intoxication
* Blurred vision

Tyco Healthcare Group (Covidien) is recalling 4,710 boxes of single-use ReliOn syringes sold at Wal-Mart and Sam’s Club nationwide between Aug. 1 and Oct. 8.

The recall only applies to the following products:

* Product name: ReliOn Insulin Syringes — 31 gauge 1 cc (with 100 syringes per box)
* Lot number: 813900 (on the back panel of the carton, or on the white paper backing of each syringe’s “peel pack”)
* Product identification number: 38396-0403-02 (on the top panel upper right-hand corner of the syringe box)

Tyco Healthcare recalled this lot of syringes in October, and Wal-Mart and Sam’s Club stores have posted information about the recall and notified more than 16,500 customers about the recall.

If you or a loved one has been injured from an Insulin overdose, please call Beltz and Ruth at 1-800-235-8978 (1-800-BeltzRuth) to discuss your legal rights.

The U.S. Consumer Product Safety Commission in cooperation with Sherwin-Williams recalled Krylon “Outdoor Spaces” UV Fabric Protector November 4, 2008.  Consumers should stop using the product immediately.

The product, Krylon Outdoor Spaces UV Fabric Protector, is intended to repel moisture and prevent outdoor fabrics from fading. But over-exposure to fumes, vapor or spray mist from the product can pose a serious respiratory hazard.

According to the CPSC’s recall notice, the part number (2900) is printed above the UPC code (724504029007) on the side of the can. Made in the U.S., it was sold in 11-ounce cans at Wal-Mart, Ace Hardware and other retail stores nationwide, and in Canada, from January 2006 through September 2008 for about $7.

Use extreme caution when using any waterproofing spray. Apply only outdoors, spray in the same direction as the wind, avoid skin contact, and report any ill effects to the CPSC, the manufacturer, and to us at 1-800-BeltzRuth (1-800-235-8978)

The psoriasis drug Raptiva is getting a “black box” warning, the FDA’s sternest warning, about the risk of life-threatening infections including a rare brain infection and meningitis.

The FDA announced that news 10/16/08.  Raptiva’s warning will highlight the risk of opportunistic infections including:

• Bacterial sepsis: a blood infection that can affect organs throughout the body
• Viral meningitis: a brain infection
• Invasive fungal disease: fungal infection that can spread throughout the body
• Progressive multifocal leukoencephalopathy (PML): a rare brain infection

Raptiva is given by injection once a week to treat moderate to severe plaque psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy) to control their psoriasis. Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, but suppressing the immune system can raise the risk of serious infections and malignancies.

Raptiva’s label will also be updated to include data from studies done on young mice that show a potential risk for permanent suppression of the immune system when given repeatedly in this age group, which the FDA says is equivalent to children up to 14 years old. Raptiva isn’t approved for use in children younger than 18.

The FDA ordered Raptiva’s “black box” warning and other label changes after receiving reports of serious infections in some patients taking Raptiva, notes Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a news release.

But the FDA acknowledges that those reports, which include one case of PML, don’t prove that Raptiva caused any illnesses.

FDA’s Advice to Patients

The FDA also urges patients to get up to date on their vaccinations before starting Raptiva, and not to get vaccinations while taking Raptiva, because they may not develop immunity to the vaccination virus.

Patients taking Raptiva should also watch for signs and symptoms of infection, as well as these problems:

• Confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems (possible symptoms of PML)
• Dizziness upon standing, weakness, or jaundice (possible symptoms of anemia)
• Bruising, bleeding gums, pinpoint-sized red or purple dots under the skin (possible symptoms of thrombocytopenia, or low platelet count)
• Worsening of psoriasis or arthritis
• Sudden onset of numbness, tingling, or weakness in the arms, legs, or face (possible signs of a nervous system disorder).

The FDA recommends that patients taking Raptiva seek immediate medical attention for those problems.

Read full FDA release for more information

FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture.

Fluoroquinolones include Cipro (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride).

FDA Warning

The Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter cold and cough medicine to include “Do Not Use” for children under the age of 4.

About 7,000 children under 11 go to emergency rooms each year after taking cough and cold medicines, according to the CDC. Roughly two-thirds of those occurred after children drank medication while unsupervised, according to the CDC.

The new labels will start showing up on store shelves this year. The CHPA says there are no plans to take products with the old labels off the shelves since the FDA hasn’t indicated a need to do so.

In January, the FDA urged parents and caregivers not to give over-the-counter cough and cold drugs to kids younger than 2. Drugmakers voluntarily took over-the-counter infant cough and cold drugs off the market in October 2007.

Public Citizen Says 29 Medications That May Cause Adverse Interactions Identified on WorstPills.org

Thyroid medications, which are among the most frequently prescribed medications in America, may adversely interact with common over-the-counter and prescription drugs, Public Citizen writes in a new September posting on its WorstPills.org Web site.

The effects of these interactions can include diminished effectiveness of the thyroid medication, diminished effectiveness of the other drugs and life-threatening effects on the blood’s ability to clot.

See press release

In the wake of Bayer’s announcement that it pulled its controversial heart surgery drug Trasylol from the market after a Canadian study suggested that its use increased surgical complications and death rates, lawsuits are seeking damages on behalf of a heart surgery patient who, after being administered Trasylol (Aprotonin), experienced renal failure requiring dialysis treatment.