BLOG TAG: FDA

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FDA Warns Consumers about Potential Hazards of Laser Toys

FDA Warns Consumers about Potential Hazards of Laser Toys

Over the past few years, consumers have become more aware of potential hazards to young children, especially with toys. The CPSC often discovers that popular children’s products can be dangerous if handled improperly. For instance, if a product is found to contain dangerous amounts of lead, such as when Leisure Ways brand children’s furniture was found to contain lead in its paint last week, it could be harmful if parts of the product are ingested by children. This week, the U.S. Food & Drug Administration is warning consumers about the dangers of toys and products that produce laser beams that are harmful to eyes.

According to the FDA Consumer Update, laser beams can cause serious eye injuries, or even blindness, if they are operated in an incorrect manner. Lasers can be dangerous to anyone in the vicinity of a beam. Officials with the FDA say, “eye injuries caused by laser light may go unnoticed, for days and even weeks, and could be permanent.” Injuries from laser beams usually aren’t painful, and can harm vision slowly over time. They can even be harmful after one use, according to the Huffington Post.

Many products, from printers and surgical tools to toys, contain “a powerful targeted beam of electromagnetic radiation” known as a laser. Radiation-emitting products, like lasers, are regulated by the FDA for safety. The FDA recommends manufacturers create toys with a minimal amount of radiation and light. However, lasers are now cheaper and more powerful, and many consumers are unaware of the risks of lasers.

Toy lasers can be found in toy guns, spinning tops that light up, “lightsabers” and optical lasers used for entertainment purposes. The FDA recommends that consumers not point lasers directly at anyone, including animals and drivers, or point them at reflective surfaces. Additionally, consumers should look for a label declaring that a product complies with 21 CFR (Code of Federal Regulations) Subchapter J.

FDA Announces Removal of Generic Wellbutrin XL 300 mg

FDA Announces Removal of Generic Wellbutrin XL 300 mg

Part of the process of achieving Food and Drug Administration approval for prescription medication is the clinical trial. During a clinical trial, the drug will be tested multiple times to determine whether it works and if it has any side effects. To determine this information, the drug is tested against a placebo so accurate comparisons can be made, and a placebo, of course, is simply nothing more than an inert pill. But it’s important to realize that while placebos are meant to do absolutely nothing, prescription drugs are actually supposed to do something.

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Actos Multidistrict Litigation Pending As EMA And FDA Still Pushing Drug As Second Line Treatment

Actos Multidistrict Litigation Pending As EMA And FDA Still Pushing Drug As Second Line Treatment

The European Medicines Agency has recently announced that, despite a serious risk for causing bladder cancer, the prescription medication Actos – or Glustin as it is known in some European countries – should still be prescribed by physicians as a second or third line treatment option for patients suffering from Type 2 diabetes. The EMA – as well as the U.S. Food and Drug Administration – contended as recently as July 2011 that Actos createded a greater risk of bladder cancer to patients using the drugs than those not using them.

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FDA Issues Stern Warning to Pfizer Over Geodon Overdoses

FDA Issues Stern Warning to Pfizer Over Geodon Overdoses

The U.S. Food and Drug Administration posted a warning letter earlier this month, directed at the pharmaceutical company Pfizer. It states that at least 13 children overdosed in Pfizer’s clinical trials for the antipsychotic medication Geodon. The FDA said the overdosing was neither “detected nor corrected in a timely manner,” and they called the violations “significant.” The FDA has ordered Pfizer to outline a plan to make certain that future clinical trials do not violate federal regulations.

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Avandia Side Effects Prompt FDA to Consider Ending Research Trial

Avandia Side Effects Prompt FDA to Consider Ending Research Trial

The U.S. Food and Drug Administration announced that it could possibly end a diabetes drug trial based on the potential dangerous side effects of the popular diabetes medication Avandia. FDA Commissioner Margaret Hamburg wrote in a letter to the U.S. Senate that the decision to possibly stop this study stems from ethics issues, as a possible recall of Avandia looms due to allegations of heart risks.

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Surgical mesh counterfeits prompt FDA warning

Surgical mesh counterfeits prompt FDA warning

The U.S. Food and Drug Administration recently released a warning about a specific brand of surgical mesh that has been counterfeited and distributed to hospitals and medical care providers. The C.R. Bard/Davol surgical mesh has been tampered with and illegally duplicated in four known product sizes.

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