Merck withheld information about the dangers of arthritis drug Vioxx

A prestigious medical journal on Thursday said Merck & Co. withheld information about the dangers of arthritis drug Vioxx in a key study, an alleged lapse that analysts said could hurt Merck as it defends itself against Vioxx-related lawsuits.

The New England Journal of Medicine said it had determined that Merck deleted data about three heart attacks among Vioxx users, and other relevant data, prior to submitting its analysis from the so-called Vigor trial to the Journal in 2000.

The trial compared the safety of Vioxx with naproxen, a widely used rheumatoid arthritis drug.

“The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about some of the article’s conclusions,” the Journal said in a statement on its Web site.

In response, Merck said it promptly and appropriately disclosed the results of the study, correctly stated possible risks of Vioxx and extensively disclosed the Vigor data to the medical community.

Risk of Birth Defects with Paxil

FDA Advising of Risk of Birth Defects with Paxil
Agency Requiring Updated Product Labeling

The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
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FDA Acts to Seize Ephedra Containing Dietary Supplements

At the request of the U.S. Food and Drug Administration (FDA), the U.S. Attorney’s Office for the Eastern District of Texas and the U.S. Attorney’s Office for the District of Oregon filed Complaints for Forfeiture against Nature’s Treat Energy Plus #1, a dietary supplement that contains ephedra, an herbal source of ephedrine alkaloids. The supplement is distributed by Nature’s Treat, Inc., Gainesville, Texas and ACD Distributing, LLC, of Eugene, Oregon.
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NeutroSpec Safety Warning

NeutroSpec (Technetium [99m Tc] fanolesomab)
Audience: Medical imaging specialists, hospital administrators and risk managers
[Posted 12/02/2005] Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab], a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium, indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen.
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NovoSeven Coagulation Factor VIIa Safety Warning

NovoSeven Coagulation Factor VIIa (Recombinant)
Audience: Hematological and other healthcare professionals
[Posted 12/01/2005] Novo Nordisk and FDA notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for NovoSeven, to provide updated safety information on thrombotic and thromboembolic adverse events, based on clinical studies in non-hemophilia patients and on post-marketing safety surveillance. A clinical study in elderly, non-hemophiliac, intracerebral hemorrhage patients indicated a potential increased risk of arterial thromboembolic adverse events with use of NovoSeven, including myocardial ischemia, myocardial infarction, cerebral ischemia and/or infarction.

Epogen & Procrit Safety Warning

Epogen (epoetin alfa)
Procrit (epoetin alfa)
Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005] Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Epogen and Procrit. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products. This has been reported predominantly in patients with CRF receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

Aranesp Safety Warning

Aranesp (darbepoetin alfa)
Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005] Amgen and FDA notified healthcare professionals of revision to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with Aranesp. This has been reported predominantly in patients with CRF receiving Aranesp by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

Flomax Safety Warning

Flomax (tamsulosin HCl)
Audience: Ophthalmologists, Urologists, and other healthcare professionals
[Posted 11/22/2005] Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient’s ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.

Study Shows Technology Gaining in the Battle Against Spam

ISP Filters Block as Much as 95% of Unsolicited E-mail; Consumers Can Take Additional Steps to Curb the Amount of Spam They Receive

According to a new study released today by the Federal Trade Commission, spammers continue to harvest email addresses from public areas of the Internet, but Internet Service Providers’ anti-spam technologies can block the vast majority of spam sent to these email addresses. The FTC staff report also found that consumers who must post their e-mail addresses on the Internet can prevent them from being harvested by using a technique known as “masking.”
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