Lexapro, Zoloft, Paxil & Prozac Warnings

Expectant women and those trying to become pregnant should avoid taking antidepressants because of a risk of birth defects, a group of U.S. obstetricians suggested Thursday.

The American College of Obstetricians issued the warning, which is published as an opinion in the December issue of the journal Obstetrics & Gynecology.

The obstetricians said exposure to selective serotonin re-uptake inhibitors or SSRIs, a class of antidepressants that includes Prozac, Zoloft, Lexapro and Paxil, during the later stages of pregnancy has been linked with short-term complications in newborns.

But the group acknowledged that reproductive-age women face a higher risk for depressive disorders. Accordingly, the college suggested that doctors should decide on a case-by-case basis if women should continue to take the antidepressants.

November 30, 2006 in Current Affairs | Permalink | Comments (2)

Viagra May Cause Blindness?

Officials from the US Food and Drug Administration (FDA) announced that they were investigating 42 reports of blindness, 38 among users of Viagra and four among users of Cialis, one of its leading competitors. Non-arteritic anterior ischemic optic neuropathy (Naion) can occur in men who are diabetic or have heart disease — the same conditions that can cause impotence and lead to Viagra use.

Pfizer is facing at least one lawsuit from a Viagra user for loss of sight.
Several experts have recently raised concerns about the possibility that Viagra might be linked to Naion. They suggested that all men suffering from the eye condition should be asked if they had taken Viagra.

Pfizer said that a review of 103 clinical trials involving 13,000 patients had found no reports of the condition and that reports of loss of vision were “extremely rare”.

May 27, 2005 in Current Affairs | Permalink | Comments (1)

Risk Management & FDA

In July 1998, Public Citizen petitioned the FDA to ban Rezulin, which, although lowering blood sugar by a different mechanism than earlier diabetes drugs, had no evidence of improved mortality or morbidity. By July 1998, there were 560 reported cases of liver damage, including 26 deaths.

After failed efforts at "risk management," Rezulin was withdrawn from the market in January 2000, by which time there were hundreds of additional cases of liver damage and 63 deaths. Other belatedly banned drugs include the painkiller Duract, the blood-pressure drug Posicor and the cholesterol-lowering drug Baycol.

Decisions to approve or remove drugs must be based on adequate evidence of both benefits and risks. For Vioxx, Celebrex and Bextra - the three COX-2 inhibitor pain/arthritis drugs - at approval there was no evidence that they were more effective than older drugs.

Only Vioxx, now withdrawn because of a significant increase in heart attacks, proved to be less dangerous to the gastrointestinal tract than older drugs. Celebrex and Bextra did not. Although at approval there was no evidence of increased cardiac risk from Vioxx or Celebrex, less than a year later a 2001 study on Vioxx found it was five times more likely than naproxen (Aleve) to cause heart attacks, and a Celebrex study prompted FDA concerns about cardiac risks for that drug.

Removing Celebrex from the market will be a major step forward for public health. For naproxen, the evidence of its harm is preliminary at best, and it is unlikely to pose cardiac risks as high as those documented for Vioxx or Celebrex. There is no basis for removing it from the market.

Unique risks without unique benefits should always be the algorithm for removing drugs.

Sidney Wolfe is the director of Public Citizen's Health Research Group and co-author of the new edition of Worst Pills, Best Pills. Public Citizen's W eb site, www.worstpills.org, lists what it says are safer alternatives to 181 drugs.

December 27, 2004 in Current Affairs, drug lawsuits | Permalink | Comments (0)

CEO Defends Celebrex

Pfizer chief executive officer Hank McKinnell said he foresaw the U.S. Food and Drug Administration adjusting labeling for the drug Celebrexrather than ordering that it be withdrawn from the market.

McKinnell said that the agency is expected to review the cardiovascular risk profile of Celebrex at a special meeting on Feb. 15.

"We fully expect that Celebrex will be found safe and effective when taken as directed," McKinnell said.

Last week, Pfizer said it uncovered possible cardiac risks for patients using large doses of Celebrex during tests using the drug to combat cancer. The FDA advised doctors to prescribe other medicines or only prescribe Celebrex in the lowest dosages possible. FDA is considering further action, such as relabeling or even withdrawal.

On Monday, Pfizer said it was dropping all advertising of Celebrex.

SG Cowen also saw Celebrex and Bextra possibly going the way of Merck's Vioxx, which was pulled from the market earlier this year due to cardiac risks. Bextra is to start carrying a warning on its labels about cardiac risks as well.

"We have removed Celebrex and Bextra from our models reflecting irreparable harm commercially, and possibly market withdrawal," analyst Steve Scala said in a note to clients.

Prudential Equity Group was almost as dire.

"The Cox-2 inhibitors appear to be a broken class," analyst Dr. Tim Anderson said in a note to clients. Cox-2 inhibitors are the class of drugs that includes Vioxx, Celebrex and Pfizer's Bextra.

In defense of his beleaguered drug, McKinnell emphasized Celebrex is of particular benefit to pain sufferers who are at risk of developing gastrointestinal bleeding problems associated with such other popular pain medications as ibuprofen and naproxen.

He added the drug eventually will be shown to lower cardiovascular incidents in certain patients.
via marketwatch.com article

December 21, 2004 in Celebrex, Current Affairs | Permalink | Comments (0)

Centocor gets OK for spinal drug

Centocor gets OK for spinal treatment

SAN FRANCISCO -- Johnson & Johnson subsidiary Centocor said Monday that it has received approval from the U.S. Food and Drug Administration for its arthritis drug Remicade to be used to treat ankylosing spondylitis, a painful spinal disorder.

Ankylosing spondylitis is a progressive inflammatory condition of the spine that can result in fusion of the spinal vertebrae and damage to hips and other joints.

Remicade, in combination with methotrexate, was recently approved as first-line therapy for patients with moderate-to-severe rheumatoid arthritis.

Remicade is also approved for treatment of Crohn's disease

Centocor said it has also updated Remicade's warning label to include information regarding pneumonia and hepatoxicity.

The company said it is advising doctors and adding a warning about possible liver damage, after receiving reports of liver reaction among patients using Remicade.

Centocor said it is also sending letters to the medical community this week about the expanded warning label.

December 21, 2004 in Current Affairs, FDA Status | Permalink | Comments (0)

Vioxx, Celebrex, Dangerous Drugs?

In light of the recent news regarding Vioxx and Merck's Celebrex, this blog will provide the latest news and information regarding potentially dangerous drugs as well as the latest news on class action lawsuits and personal injury attorneys that may represent users of Vioxx and Celebrex and other drug lawsuits.

December 20, 2004 in Celebrex, Current Affairs, drug lawsuits, Vioxx | Permalink | Comments (2)