FDA Issues Tylenol Safety Warning

The Food and Drug Administration is urging parents to choose generic children’s medications over Tylenol as it broadens its investigation into manufacturing facilities operated by Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare.

New product safety concerns have arisen in the weeks after an April 30 recall involving McNeil’s Fort Washington facility in Pennsylvania, prompting the FDA to start investigating other manufacturing sites. McNeil recalled 43 over-the-counter children’s medicines it manufactures for Johnson & Johnson, including various flavors of liquid Tylenol, Motrin, Benadryl and Zyrtec. The FDA has not said how many facilities are being investigated.

McNeil Consumer Healthcare issued the April 30 recall voluntarily in consultation with the FDA. In a visit to McNeil’s Fort Washington facility, FDA officials uncovered inconsistent active ingredient concentrations, extremely potent metal particles in some medicines, an inadequate testing facility, poorly trained employees and drums of raw materials contaminated with bacteria.The full inspection report is available here.

Meanwhile, the House Committee on Oversight and Government Reform is scheduled on Thursday, May 27, 2010 to hold a hearing on the recent Tylenol recalls and whether McNeil properly handled consumer complaints.  In a recent Fortune Magazine interview, Johnson & Johnson Chief Executive William Weldon admitted that his company owed an apology.  Mr. Weldon has been invited to testify at the May 27 hearing.

The Pennsylvania facility has since been shut down but may resume operation once, according to Johnson & Johnson spokesman James Freeman, “we have taken the necessary corrective actions and can assure the quality of products made there”.

Tylenol has been involved in other product safety recalls in recent years. In 2008, McNeil recalled 51 types of Tylenol after consumer complaints of diarrhea, vomiting and other illness. The company said the medications – mostly all for children and infants – had been contaminated by trace amounts of a chemical used in shipping.

In 2008, McNeil recalled 21 types of children’s and infants’ Tylenolbliquid products, saying an active ingredient did not meet all quality standards.

For additional information on the Johnson & Johnson recalls, see the FDA’s website.

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AstraZeneca Facing Over 25,000 Lawsuits–Antipsychotic Drug Claimed to Cause Diabetes

AstraZeneca is preparing for a products liability trial next week over claims that their antipsychotic medication Seroquel causes diabetes. About 26,000 lawsuits have been filed against the drugmaker, with one of many trials set for February 16th in New Jersey.  That trial will be the first of thousands filed in New Jersey alone.  Seroquel is the UK-based drugmaker’s second most popular drug after Nexium, the well known heartburn relief medication, and is used to treat bipolar disorder and depression. AstraZeneca claims that the plaintiffs’ evidence is insufficient to show that the drug was responsible for their alleged personal injuries.

In January, U.S. District Judge Anne Conway, who is overseeing all federal Seroquel litigation, ordered the parties to attend mediation.  The parties were unable to reach a settlement agreement after two days of talks.  The mediator, George Washington University Law Professor Stephen Saltzberg, said he expects further settlement negotiations to occur.  Judge Conway, who sits in Florida, has said that she will ask a panel of judges to return the 6,000 consolidated cases scheduled to come before her to their resident states, adding to the litigation headache.

Seroquel was introduced in 1997 and has long been linked to weight gain and diabetes.  The plaintiffs are claiming that AstraZeneca downplayed the risk of diabetes, cherry-picked positive trial results, and buried negative results.  Documents discovered in 2009 appear to substantiate the plaintiffs’ claims.  As early as 1997, emails between AstraZeneca officials reveal that the drugmaker hid negative trial results from US and Canadian investigators.  AstraZeneca is not the first antipsychotic drugmaker to be hit with claims that its medication causes diabetes.  In 2009, Zyprexra-maker Eli Lilly agreed to pay at least $1.2 billion to similar settle lawsuits filed by about 31,000 patients.

For more information on Seroquel side effects, see the Seroquel website.  The Alliance for Human Research Protection has a collection of articles on the Seroquel product liability litigation.
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Massachusetts Consumers Should Take Care If Using Certain Antibiotics–FDA Warns of Tendon Trouble

A commonly prescribed class of antibiotics have been issued the strongest available warning by the Food and Drug Administration (FDA) due to the risk of potentially debilitating personal injury. Levaquin (levofloxicin) and Cipro (ciprofloxacin) are in the class of antibiotics, called fluoroquinolones, and are used to treat illnesses like sinus infections, urinary tract infections, pneumonia, kidney infections and several types of skin infections. People using Levaquin and other fluoroquinolones are at increased risk for tendonitis and tendon ruptures, especially those over 50 years of age, those taking steroids, or people that have had a lung, kidney or heart transplant.  Tendonitis and tendon ruptures have also been reported in people without elevated risk factors, and can even occur months after discontinuing the drug.

The most commonly reported tendon injuries have occured in the Achilles tendon, but ruptures have also occurred in the rotator cuff, hand, and tendons in other parts of the body. Tendon injuries can be extremely painful, are potentially debilitating, and may require surgery to correct. People using fluoroquinolones should seek medical attention if they have bruising in the tendon area after a possible injury, hear or feel a pop or snap, are unable to put weight on an injured area, or have other reason to believe that a tendon is not functioning properly. 

Flouroquinolones have also been linked to other serious side effects and personal injuries, such as renal failure, and users have reported side effects that feel like fibromyalgia and chronic fatigue syndrome.  Some people experience an alleviation of side effects shortly after stopping use of the antibiotic.  Others experience long-term or even permanent side effects.  While sometimes the use of fluoroquinolones cannot be avoided, patients should inquire into alternative medications. 

To report an adverse effect resulting from the use of Levaquin or another fluoroquinolone antibiotic, call the FDA MedWatch program at 1-800-FDA-1088 or visit the MedWatch website.

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