FDA & Prescription Drugs | InjuryBoard Denver

A jury in Philadelphia ruled against McNeil Pharmaceuticals as they awarded $5 million USD to parents whose 1 year-old boy died when he was given Infants' Tylenol. The parents gave their boy a Children's Tylenol dose of Infant's Tylenol, unaware that Infant's Tylenol has three times the concentration of acetaminophen. The family's attorney said that McNeil should not only add an additional...

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In an urgent announcement, WebMD reports that the Mentholatum Company has recalled the WellPatch Cough & Cold Soothing Vapor Pads because children who take off the pad and chew on it could get seriously ill and may even experience seizures. The FDA advises anyone in possession of the pads to discard or return them to the purchase place and receive a full refund. The label on the Vapor Pads...

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The Los Angeles Times reported that the EPA, in a long anticipated move, has banned Lindane for use in pesticides. Lindane is a pesticide similar to DDT and over 52 different countries have limited its use. Lindane can cause significant damage to the environment as it does not break down naturally and can contaminate food chains and oceans. In addition, Lindanes can cause severe damage to humans...

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According to a report by Reuters Health, certain types of painkillers could increase the risk of heart attack. A study in Finland not only examined the effects of painkillers such as Celebrex, but also other non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin. The study concluded that the use of any type of NSAIDs, may increase risk of heart attacks by 40%. This...

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According to Reuters, a federal appeals court may cut short the patent expiration date for Pfizer's blockbuster drug, Lipitor. The U.S. Appeals Court cancelled one of the two patents in the case, which may result in Lipitor's patent expiration date moving up from June 2011 to March 2010.A brand name drug will usually lose 80% of the market when generic drugs become available. Pfizer stands to...

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The FDA accused Eli Lilly and Co. of "misleading" marketing, issued a formal warning letter, and asked them to stop publishing and distributing a brochure about the drug Alimta. If Lilly does not resolve the issue the FDA may decide to impose various penalties on the company. Federal officials reported that Lilly "omits material facts and risk information essential to the safe and effective use"...

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According to the AP, a study indicates that the popular drug Gleevec (Glivec) may cause severe heart problems, including congestive heart failure. While the report, by Dr. Thomas Force a professor at a Medical College in Philadelphia, indicates significant heart damage can occur while using Gleevec, Force contends that this study is only a warning to doctors and consumers of the potential...

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According to a report in the Dallas Morning News, medical specialists met to determine the effect of Fosamax and other osteoporosis medication on the jaw bone. In 2003, doctors first began seeing patients develop osteonecrosis of the jaw while using Fosamax and other similar drugs. Since then, over 400 other instances have been reported to medical journals. Osteonecrosis in the jaw is very...

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According to a report by ABC News, a joint taskforce, set up by the British Pharmaceutical Industry and BioIndustry Association, advised on new procedure to protect patients during drug trials, following a devastating trial that injured six people. The drug trial of TGN 1412, manufactured by the company TeGenero, shocked the community and pharmaceutical industry when it left six men critically...

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According to the AP, the FDA warned July 21, that an unconventional treatment for Lyme disease could cause serious injury and even death. Alternative health physicians and others purporting to be doctors prepare and inject into patients a mixture known as bismacine or chromocine, which contains large amounts of heavy metal bismuth. At least one person died while using this product and others...

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According to a report by NEWS.com, Roche, a large prescription drug manufacturer, crossed an ethical boundary when it treated hundreds of doctors to expensive meals at some of Australia's most exclusive restaurants. One of these meals cost more than $65,000 USD as Roche paid the bill for over 200 cancer specialists to eat at the Guillaume at Bennelong, and exclusive restaurant inside the famous...

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In recent weeks, dozens of e-mails between internal FDA officials were turned over to the New York Times. The e-mails show that at least four FDA officials had serious reservations about the safety of the popular antibiotic, Ketek, which was recently forced to change its label to include stronger warnings. Dr. David Graham, part of the FDA's drug safety office, wrote in a message dated June 16...

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According to a recent article on Yahoo! News, the producer of Azathioprine, Roxane Laboratories, Inc., on June 13, 2006, announced a recall across the United States and Puerto Rico of Azathioprine tablets, manufacturing lot 558470A. Azathioprine helps to prevent the rejection of kidneys following kidney transplants and in some cases helps treat severe rheumatoid arthritis. The recall is...

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According to The Doctor's Guide News, officials in Singapore have reported a dramatic increase in the reported cases of Fusarium Keratitis, a severe fungal eye infection possible linked to Bausch and Lomb ReNu with MoisureLoc. A study by the Singapore Eye Research Institute examined contact lens wearers rate of Fusarium keratitis during a 15-month period. Of the contact lens wearers diagnosed...

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As a regulatory agency, the authority of the FDA is limited to the creation of regulations which implement the responsibilities delegated to FDA by Congress. Since Congress did not expressly preempt state law tort claims, FDA has no authority to establish express preemption.FDA has no authority to interpret the law. The doctrines of conflict preemption are judicially created and judicially...

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