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FDA Orders Most Serious Safety Warning for Botox, Similar Drugs

Federal regulators have ordered that botulinum toxin  injections, including Botox, Botox Cosmetic and Myobloc, bear a new black box warning regarding their risk of potentially life-threatening complication when the effects of the toxin spread far beyond the injection site.  The black box, the Food & Drug Administration’s (FDA) most serious safety warning, will also apply  to Dysport, a new botulinum injection treatment just approved by the agency today.

Last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said at the time that it had received reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing. (more…)

JPMorgan Ensnared in Madoff Lawsuit

MLSMK Investments Co., a Palm Beach, Florida- based partnership, has filed suit against JPMorgan Chase over losses it sustained as a result of   Bernard Madoff’s Ponzi scheme.

As we reported in January, in 2006, JPMorgan  had started offering investors a way to leverage their bets on the future performance of two Fairfield Greenwich Group hedge funds that invested with  Madoff. MLSMK invested $12.8 million with JPMorgan  in this manner from October to December.  (more…)

Ford Offers To Inspect, Repair Faulty Tire Valve Stem on 1 Million Vehicles

Despite fears that defective tire valve stems could be putting driver and passengers in some of their vehicles at risk, Ford will not be issuing a recall. Rather, the company will be offering free dealer inspections, and will replace  tire valves free of charge when necessary.

The Ford tire valve stems, which were made by a Chinese firm called TopSeal Automotive, have the potential to crack.  In such a case, they could cause a tire to deflate or rupture, resulting in a crash. Several accidents, including some that resulted in fatalities, have been blamed on such valve stem failures.  (more…)

Rocephine – Calcium Guidelines Updated

In new guidance released today, the Food & Drug Administration (FDA) said the antibiotic Rocephin (ceftriaxone) can be administered with calcium-containing products in patients older than 28 days.

According to the FDA’s new guidelines:

  • Concomitant use of Rocephin and intravenous calcium-containing products is contraindicated in neonates (less than 28 days of age).  Rocephin should not be used in neonates less 28 days of age) if they are receiving (or are expected to receive) calcium-containing intravenous products.
  • In patients older than 28 days of age, Rocephin and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.
  • Rocephin must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group.
  • The FDA now recommends that Rocephin and calcium-containing products may be used concomitantly in patients older than 28 days of age, using the precautionary steps above because the risk of precipitation is low in this population.  the agency had previously recommended, but no longer recommends, that in all age groups Rocephin and calcium-containing products should not be administered within 48 hours of one another. (more…)

Raptiva Recalled

Genentech’s psoriasis drug, Raptiva, is being recalled because of its association with an often-fatal brain disease.  The injectable  drug will no longer be available in the U.S. after June 8, 2009.

According to a letter Genentech has sent to healthcare providers, Raptiva is being pulled from the U.S. market because three patients treated with the drug died from progressive multifocal leukoencephalopathy (PML). PML is a serious and almost always fatal brain infection caused by a virus.  Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.  Because the risk/benefit profile for Raptiva has changed, it will be subject to a voluntary, phased withdrawal, Genetech said. (more…)

Group Seeks Probe of iPhone Skype Restrictions

Since its introduction last week, the Skype application for iPhone has become one of the most popular downloads at the Apple iPhone store.  But some are complaining that restrictions placed on the Skype application by AT&T and Apple are anticompetitive and quite possibly a violation of federal law.

Skype is  a Voice over Internet Protocol (VoIP) application that competes with AT&T’s own voice service.  By using Skype, iPhone customers should be able to sidestep AT&T, allowing them access to cheaper voice plans that offer fewer minutes. iPhone users can also save money on international calls by using Skype. (more…)

Deadly Cribs Recalled

Suntech Enterprises is recalling 1900 potentially defective SunKids convertible cribs that pose a suffocation hazard to infants.

According to the recall notice, the sides of the  SunKids cribs are made of mesh that expands, creating a gap between the side and the crib’s mattress if it’s not zipped into place, or a gap between the side and an added mattress. A young child can slip into this gap and become entrapped or suffocate. Also, the crib’s drop side can fail to fully latch posing a fall hazard to young children. (more…)

Recall Issued for Two Types of Evenflo High Chairs

Urgent recalls for two different models of  Defective Evenflo high chairs that have injured children were issued today by the Consumer Products Safety Commission.

The first Evenflo recall involves 640,000 Envision High Chairs.  Evenflo says  has received 320 reports of seatbacks detaching or reclining unexpectedly, resulting in 19 reports of bumps and bruises to the head and 35 reports of other injuries including abrasions, pinches and bruises. Evenflo has also received 13 reports of recline fasteners and screws falling out of the high chair, resulting in one incident in which a fastener and/or screws were found in a child’s hand or mouth but were removed before choking occurred. (more…)

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Great Photography

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Personal Injury Lawyer Nassau County

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Whistle Blower

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