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FDA & Prescription Drugs | InjuryBoard Philadelphia

Posted by Jamie Sheller |
February 13, 2008 3:49 PM

Recently, the FDA announced it will take action against all companies marketing unapproved, injectable colchicine. Colchicine is a drug used to treat gout. This drug is extremely dangerous since fatal doses are very similar to the effective doses. Adverse effects of this drug include death, low blood cell counts, cardiac events, and organ failure. If you or a loved one has been injured as a...

Posted by Jamie Sheller |
February 07, 2008 2:00 PM

Fosamx, a drug used for treatment of osteoporosis, has been linked to a devastating condition called Osteonecrosis of the Jaw (ONJ) or Dead Jaw Syndrome. ONJ keeps the jawbones of patients from healing properly after routine dental procedures, and in extreme cases caused jawbones to rot and die. Several independent studies discovered that a number of patients taking Fosamax developed this...

Posted by Jamie Sheller |
January 29, 2008 2:36 PM

Just recently, the FDA changed the warnings on the Ortho Evra birth control patch yet again. This time the agency updated the warnings to include the results of a new study. This new study showed that users of the Ortho Evra patch are twice as likely to develop blood clots known as thromboembolism (VTE). Women between the ages of 15-44 are among those facing the greater risk. The FDA...

The FDA has notified health professionals that Chantix, a smoking cessation product, has been associated with erratic behavior in patients. Some patients reported suicidal thoughts and aggressive behavior within days or weeks of taking Chantix. The FDA is reviewing the cases. For more information about Chantix, view this page. For more information on this subject, please see our section on...

Zetia, a cholesterol-reducing drug, marketed by Merck and Shering Plough, has recently come under scrutiny by the House Committee on Energy and Commerce. The House is investigating the results of a recent clinical trial of Zetia. This clinical trial was designed to confirm Zetia's ability to reduce the growth of plaque in arteries when combined with another cholesterol drug. Although the...

At the request of the FDA, Bayer Pharmaceuticals Corp. has agreed to stop marketing Trasylol. Trasylol is a drug that controls bleeding during heart surgery. According to recent studies, using Trasylol over other similar drugs significantly increases the risk of death, kidney failure, stroke or heart problems. The FDA is waiting for the results from a new study being conducted in Canada to...

Posted by Jamie Sheller |
December 04, 2007 3:50 PM

We have all goofed up now and then. However, some mistakes costs more than others. Just recently, certain hospitals have gained national attention for misadministering medication to infants. According to the Los Angeles Times, approximately 1.5 million Americans per year are injured after receiving the wrong medications or the incorrect dose. While we may never know who is to blame,...

By now, many parents have been asked if they would like to vaccinate their children from the flu virus. More than likely, as a concerned parent you may have given your consent. Now, according to a recent article in the New York Times, the FDA is considering putting stronger warnings on flu vaccinations for children. Apparently, the drug Tamiflu has been connected to pyschiatric problems in...

Posted by Jamie Sheller |
November 16, 2007 10:58 AM

Earlier this week, the FDA issued new warning labels to Procrit, Epogen, and Aranesp. These drugs are used to increase hemoglobin levels in patients with chronic renal failure and cancer. Changes to the warnings for patients with cancer include a risk of shortened survival and tumor progression when the dosage reaches a certain level. The warning changes for patients with chronic renal...

Posted by Jamie Sheller |
November 16, 2007 10:49 AM

Cefepime, marketed as Maxipime, is manufactured by Bristol Meyers Squibb. A recent study of this drug has raised concerns about the increased mortality rate associated with its use. Based on this study, the FDA has begun a safety review which will not be completed for another four months. Cefepine or Maxipine is an antibioltic used for patients who have infections of the ear, chest, skin,...

The FDA recently announced that GlaxoSmithKline, the manufacturer of Avandia, will be changing its boxed warnings to include the risk of heart attacks. Avandia is a drug used to treat type 2 diabetes. Studies have shown that people with type 2 diabetes who have an underlying heart disease or are at an increased risk of heart attacks while using this medication. For more information view the...

Posted by Jamie Sheller |
November 15, 2007 3:43 PM

Last week, Merck & Co. agreed to a $4.85 Billion settlement with thousands of plaintiffs. Over the past few years, plaintiffs who were suffered significant injuries caused by Merck's powerful painkiller Vioxx. This settlement is to compensate those victims and put an end to another round of trials by other plaintiffs. Not surprisingly, as part of the settlement agreement Merck did not admit...

Cephalon recently issued letters to healthcare providers that Provigil can cause life-threatening skin disease including Stevens-Johnson Syndrome. Provigil is a medication for adults who suffer from excessive sleepiness. Common users are adults who have narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Cephalon has revised its warning to instruct patients...

Posted by Jamie Sheller |
October 31, 2007 11:26 AM

Earlier this week, the FDA, along with Roche, the maker of Cellcept, notified healthcare providers that use of Cellcept is associated with pregnancy loss, and increased risk of congenital malfunctions. Specific abnormalities include cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Cellcept is typically given to kidney, heart or liver transplant recipients...

At the request of the FDA, Gadolinium makers -- Bayer, GE-Healthcare, Bracco, and Mallinckrodt, notified Healthcare providers that its gadolinium-based contrast agents increase the risk of NSF in certain patients. Gadolinium contrast agents are used by medical providers to enhance the quality of MRI scans. The five gadolinium-based contrast agents are commonly known as: Magnevist, Omniscan,...

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