FDA Warns Doctors To Stop Using Enteryx

The government is warning doctors to stop using Enteryx, an injection used to treat acid reflux disease, saying it has been connected to serious health problems and, in at least one case, a death.

Many of the problems with Enteryx have occurred when it is injected imprecisely, missing its intended destination and passing through the wall of the esophagus, sometimes entering other internal organs or the bloodstream, risking blockage of blood vessels, the Food and Drug Administration said. Doctors have not always immediately detected a faulty injection.

Enteryx is injected as a liquid that solidifies into a spongy material that cannot be removed. When it is injected properly, it strengthens the lower esophagus, helping prevent stomach acid from entering it and causing pain.

The FDA did not provide specific numbers on the number of problems that have been discovered. Manufacturer Boston Scientific issued a recall on Sept. 23 but blamed the problems entirely on faulty injection technique.

The FDA also cited at least two instances in which Enteryx was injected properly but patients still developed problems.

The death was blamed on Enteryx being injected into the wall of the aorta.

The FDA said people who received the injection and are suffering from chest, stomach or side pain, flu-like symptoms, including fever, cough or shortness of breath, or fainting spells should contact their doctor immediately.

Boston Scientific is advising people who have received an Enteryx injection in the last 30 days to see their doctor for a follow-up, but the FDA said some problems associated with the injection have occurred seven weeks later.

October 18, 2005 in FDA Status | Permalink | Comments (0)

Federal approval for Vytorin

Schering-Plough, best known for allergy medications, has just gotten federal approval for Vytorin, a cholesterol drug that should be a blockbuster.

January 23, 2005 in FDA Status | Permalink | Comments (1)

FDA Requires Further Review for Acroxia

WHITEHOUSE STATION, N.J., October 29, 2004 - Merck & Co., Inc. today confirmed that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Arcoxia (etoricoxib).

The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for Arcoxia are required.

"We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans with arthritis and pain," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck & Co., Inc. "We plan to work with the FDA to address what steps need to be taken before the application may be approved."

Arcoxia has been launched in 48 countries worldwide in Europe, Latin America and the Asia-Pacific region. Merck will continue to work with regulatory agencies in the countries where Arcoxia is approved, including the European Medicines Agency which recently announced plans for a safety review of the COX-2s, to assess whether changes to the prescribing information for this class of drugs, including Arcoxia, are warranted.

Vioxx, Celebrex and Bextra--have already been on the market.

January 17, 2005 in FDA Status | Permalink | Comments (0)

FDA panel rejects over-the-counter Statin

BETHESDA, Md. - Federal health advisers recommended against over-the-counter sales of a cholesterol drug Friday, saying that patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life.

The safety of Mevacor is well-established, but advisers worried that the wrong people might take it if sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it.

The vote on the advisory committee was 20-3.

Advisers expressed misgivings because studies that simulated over-the-counter sales indicated that 90 percent of people who took Mevacor didn’t meet the requirements of the label. Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.

The panel advising the Food and Drug Administration also voiced concern that women who were pregnant and did not know it would take Mevacor and possibly damage the developing fetus.

Supporters argued that making Mevacor more easily available would help get needed treatment to millions of Americans at moderate risk of heart disease who needed to lower cholesterol levels but were not taking helpful drugs.

And several advisers said they liked the idea of wider availability of statins like Mevacor, which lower cholesterol by limiting the buildup of artery-clogging fat deposits and reduce risk of heart attack by about a third.

'A massive uncontrolled experiment'
“There have been times in my career when I thought the statins ought to be in the drinking water,” said Dr. Frank F. Davidoff, editor emeritus of Annals of Internal Medicine. But at this point, making them available over the counter “would be a massive, uncontrolled experiment.”

The application was filed by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture set up to market over-the-counter versions of drugs with expiring patents.

The companies said in a statement Friday they were disappointed by the decision but encouraged by the discussion and would work with the FDA toward getting the drug sold without prescription. “We continue to believe in the benefits of Mevacor ... as an over-the-counter medication to help lower cholesterol and contribute to improved overall public health,” said spokesman Tony Plohoros.

January 16, 2005 in FDA Status | 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)