- Staff Writer | May 31, 2006 1:10 PM |
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FDA & Prescription DrugsAccording to the New York Times, Merck admitted yesterday that it was in error when it reported in 2005 that Vioxx caused heart problems only after 18 months of continuous use. Scientists outside of Merck said that Merck's admission, along with clinical trials and real-world Vioxx use, supports critics' claims that Vioxx caused heart problems quickly. Merck's admission could undermine one of...
- Staff Writer | May 21, 2006 1:57 PM |
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Medical MalpracticeMany of you have learned of recent problems associated with implantable cardiac devices. Guidant Corporation's implantable defibrillator has been associated with potentially fatal complications. As a result of negative publicity, Guidant created a panel to investigate complaints. The May 18 edition of the New England Journal of Medicine contains an early release of their findings. Of note,...
- Staff Writer | May 13, 2006 10:25 PM |
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FDA & Prescription DrugsThe Singapore's Ministry of Health ("MOH") has also been active in investigating claims of Fusarium keratitis resulting from the use of Bausch & Lomb's ReNu with MoistureLoc. As of February 20, 2006, the MOH had found 39 cases that tested positive for Fusarium, and each person had a history of contact lens use. Out of the 39 cases, 34 said that they had used ReNu. The majority of the 39...
- Staff Writer | May 12, 2006 10:23 PM |
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FDA & Prescription DrugsOn April 10, 2006 (updated: April 21, 2006), Daniel G. Schultz, M.D., Director Center for Devices and Radiological Health (part of the FDA), signed a Dear Healthcare Practitioner letter (Preliminary Public Health Notification-Fungal Keratitis Infections Related to Contact Lens Use, available at http://www.fda.gov/cdrh/safety/041006-keratitis.html). It provided updated information on the recent...
- Staff Writer | May 11, 2006 10:21 PM |
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FDA & Prescription DrugsClusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. See http://www.aoa.org/x5161.xml. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions both in Singapore and Hong Kong. On March 8, 2006, The Centers for Disease Control and Prevention ("CDC") received a report from an ophthalmologist in New...
- Staff Writer | May 11, 2006 7:55 PM |
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Medical MalpracticeToday's edition of The New England Journal of Medicine sheds light on an erroneous claim often made by medical malpractice insurance companies. The insurance community-- and the current administration--- has long claimed that high premiums are brought on largely by frivolous or unfounded litigation. Today's article should settle this issue once and for all.The NEJM (the world's most prestigious...
- Staff Writer | May 10, 2006 10:20 PM |
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FDA & Prescription DrugsAlexidine is a disinfectant that traditionally has been used in mouthwash solutions. Its first use in contact lens solutions was in ReNu with MoistureLoc, thus it is a "new" product in this arena. It is believed that Alexidine is the cause or is a partial cause of the problems with this product. The current theory is that ReNu with MoistureLoc does not have sufficient disinfectant efficacy --...
- Staff Writer | May 09, 2006 10:19 PM |
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FDA & Prescription DrugsFungal keratitis is an extremely serious eye infection that can develop through the whole depth of the cornea. The infection can require prolonged drug therapy with antifungals such as natamycin or nystatin. If drugs do not work and the eye is damaged, surgery may be necessary to remove fungal ulcers and/or lesions, or to implant a shell to preserve the shape and structure of the eye. Symptoms...
- Staff Writer | May 08, 2006 10:17 PM |
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FDA & Prescription DrugsWhat is ReNu with MoistureLoc?ReNu with MoistureLoc first became commercially available in the United States in 2004. It is a daily use contact lens solution that according to the package insert is used in "the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses." Users are directed to soak their contact lenses...
- Staff Writer | May 05, 2006 8:06 PM |
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FDA & Prescription DrugsBristol-Myers Squibb Co. will stop making and selling its antibiotic Tequin, but existing supplies will remain in place and will not be recalled. Tequin's safety has been in question, and the FDA increased warnings on the drug's label in February. The drug is suspected of causing both high and low blood sugar in some patients; and the manufacturer has warned that diabetics shouldn't use it,...
- Staff Writer | May 04, 2006 8:00 PM |
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FDA & Prescription DrugsA new Canadian study shows that one-quarter of patients who suffered a heart attack while taking Vioxx did so within two weeks of taking their first prescription, much earlier than suggested by previous studies. The study was undertaken by McGill University Health Center in Canada, and involved analyzing the medical records of 239 elderly patients who had heart attacks while on Vioxx. "For...
- Staff Writer | May 03, 2006 8:29 PM |
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FDA & Prescription DrugsThe Wall Street Journal recently investigated a clinical study involving 24,000 patients, referred to as 3014, which analyzed the safety of Ketek, a popular antibiotic sold by Sanofi-Aventis SA. Reports of severe liver damage, including death, have surfaced among patients taking Ketek, and the WSJ's investigation reveals serious flaws in the study, principally due to questionable practices by...
- Staff Writer | May 02, 2006 8:25 PM |
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FDA & Prescription DrugsFierceBiotech reports that former FDA commissioner Lester Crawford is under criminal investigation for possible financial ties to the drug developers he regulated at the FDA. The investigation is focusing on investments he or his wife had in companies that depended on the FDA for regulatory approvals. As John Carroll of FierceBiotech notes, "The FDA needs to set ethical standards, it needs to...
- Staff Writer | May 02, 2006 8:14 PM |
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FDA & Prescription DrugsPascal Company, Inc., the maker of NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse, has recalled all lots and flavors of its oral rinse due to possible contamination by Burkholderia cepacia (B. cepacia) and Pseudomonas aeruginosa bacteria. Although B. cepacia poses little medical risk to healthy people, individuals with weakened immune systems or...
- Staff Writer | May 02, 2006 10:39 AM |
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FDA & Prescription DrugsBristol-Myers Squibb is warning against the use of the antibiotic drug Tequin in diabetic patients after reports of several fatalities, the U.S. Food and Drug Administration said recently.According to the FDA, the company is adding a contraindication warning for diabetics to the drug's label as well as strengthening its warning that Tequin can cause both low and high blood sugar levels in...
- Staff Writer | May 01, 2006 8:35 PM |
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FDA & Prescription DrugsA drug currently used for the treatment of AIDS patients is showing promise in animal studies as a preventive, but the drug's maker, Gilead, is keeping a low profile, based partly on fears that Truvada will be seen as a biomedical condom that might promote unsafe sex and lead to a backlash against a company that has become a Wall Street darling.