FDA Panel Seeks New Limits on Powerful Painkiller Hydrocodone

An advisory panel of the Food and Drug Administration (FDA) has recommended that the agency put tighter restrictions on the common painkiller hydrocodone, an ingredient in brand-name drugs such as Vicodin. The vote of the panel was 19-10: a majority to be sure, but certainly not unanimous.

Hydrocodone/paracetamol 5/500 tablets (Mallinckrodt). Photo: Elbreapoly

The panel is calling for hydrocodone, an opioid, to be made a Schedule II drug, which will place it in the same category as morphine, fentanyl, and oxycodone. Hydrocodone is currently in Schedule III.The FDA is likely to follow the panel's advice, according to the New York Times. The agency is seeking to limit widespread abuse of painkillers; the Times article notes that the number of deaths from pain drugs has increased fourfold since 1999.

Among other things, being in the more restrictive Schedule II would mean that hydrocodone prescriptions would be harder to refill (a patient would need to get a new prescription to get a refill). The drug could also not be obtained by faxed prescriptions.

Hydrocodone is the most frequently prescribed pain medication in the U.S., and some experts say it is because of the misconception in the medical community that it is not as dangerous or addictive as Schedule II drugs such as Percocet or methadone.

Other professionals question whether putting hydrocodone in Schedule II would actually limit its abuse, and may make it harder to obtain for patients suffering from pain.

The FDA panel is hoping to make the nation's most-prescribed painkiller less of a killer.

Alli and Xenical: Risk for Liver Damage?

The FDA is investigating whether the weight-loss drug orlical may be causing liver damage. The only medication approved by the FDA for weight loss, orlical is sold as the over-the-counter drug Alli and as the prescription drug Xenical. An article from the Associated Press says that the agency announced yesterday that it had received 30 reports of patients with liver damage from taking Alli and Xenical.

According to an FDA statement (link below), "Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases." It says that it is continuing to analyze the data.

The FDA has said that it hasn't found a definitive association between orlistat and liver injury, and recommends that users of the drug keep using it. The agency advises patients to consult their doctor if they experience any of the possible signs of liver injury or damage, such as:

• weakness or fatigue
  
• fever
  
• jaundice
  
• brown urine
  
• nausea or vomiting
  
• abdominal pain

You can read the FDA's statement about Xenical, Alli, and orlistat here. The FDA approved Xenical in 1999; Alli gained approval in 2007. Xenical contains 120mg of orlistat, while Alli has 60mg.

You can find out more about Xenical at the Drugs.com profile page or at the manufacturer's Web site, www.xenical.com.

Heparin: A Common Drug That's Getting a Lot of Attention

Heparin, a blood thinner, is one of the most common drugs used in health care today. Tonight's "60 Minutes" led off with the story of actor Dennis Quaid and his wife, who saw their twins almost die from a ten-thousand fold overdose of Heparin.

To be technical, Heparin doesn't really "thin" the blood but prevents it from coagulating (clotting). The Quaid twins were supposed to be treated with Hep-Lock, a drug used to flush out catheters and other medical equipment, and instead were given Heparin... and the adult-strength Heparin is 10,000 times stronger than Hep-Lock.

Heparin, whose main manufacturer is U.S. drug maker Baxter International, has also been the subject of a recall by U.S. authorities due to a number of deaths it is believed resulted from contamination at the Chinese source of one of the main ingredients of Heparin. The Quaid situation is another Heparin-related headache for Baxter, notes an article in the Wall Street Journal. The problem is said to have results in 19 deaths in the U.S.

The Journal has previously run articles about how the main ingredient in Heparin is obtained from the intestines of pigs, and it has noted unsanitary conditions at at least one facility in China.

Medline Plus, a Web site from the U.S. National Library of Medicine, has a good layman's article on Heparin, how and why it's used, and the recent problems with the drug. Drugs.com has good question and answer page about Heparin.

Baxter's Heparin Recalls Expands as More Reactions Reported

Drug maker Baxter International is expanding its recall of heparin, a blood-thinning drug, as the medication is suspected in more patient deaths.

Heparin, one of the most widely used medications, has been suspected as the cause of 21 deaths and close to 450 "adverse events," and almost 400 of those events involved heparin made by Baxter (ticker symbol BAX).

Baxter makes half of the heparin used in the U.S., but authorities don't expect a shortage of the drug. The company APP Pharmaceuticals, which makes the other half of the U.S. supply of heparin, has increased its output to help make up the shortfall from Baxter.

An article in today's Wall Street Journal says that the FDA has found quality control lapses at a plant in China that makes the active ingredient used in heparin, but haven't yet identified the precise cause of the adverse reactions.

New Drug Approved to Fight Breast Cancer

The Food and Drug Administration Friday approved the use of the osteoporosis drug Evista to prevent invasive breast cancer in some groups of post-menopausal women who are at risk for breast cancer.

"Today's action provides an important new option for women at heightened risk of breast cancer," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared news release. The statement cautioned that because Evista can have serious side effects, each patient should talk with her health care provider about whether the drug is appropriate.

Side effects of Evista are said to include blood clots and stroke, along with lesser symptoms such as hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating, according to the FDA.

The drug's maker, Eli Lilly and Company, said, "For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer."

The only other drug that has been approved for reducing the chance of breast cancer is tamoxifen, which has had a controversial history due to its side effects.

Female Sex Patch On Sale in Europe

Britain's National Health Service has approved a patch that is claimed to help women regain their sex drive. The BBC earlier reported on the product's pending approval.

The product, Intrinsa, is the first treatment for women with low sex drive, and is available only by prescription for women who have had an early menopause because of surgery. It uses a female-specific form of testosterone. Although testosterone is often considered a male hormone, women also produce it in the ovaries.

Intrinsa has not been approved for use in the U.S. Reportedly regulators there had concerns about the safety of Intrinsa.

Doctors said there was no quick fix for low sex drive, and medical treatment was just one part of the therapy. And they emphasized that Intrinsa should not be seen as some kind of Viagra for women.

About a million women in the UK have had an early menopause because of surgery to remove their ovaries during hysterectomy for conditions such as heavy bleeding and pelvic pain, according to Procter and Gamble, the maker of the Intrinsa patch.

Another company, BioSante, has created a product called LibiGel, which an article in CNNMoney describes as "a metered-dose testosterone gel that's rubbed into the shoulder." This product is not yet on the market; it should soon enter Phase 3 safety trials. The company is looking to get approval for LibiGel to treat women who have entered menopause after having their ovaries surgically removed.

According to BioSante's CEO, a woman's natural testosterone levels drop by half right after surgery, which causes a "drop in desire and sexual activity." BioSante is hoping that LibiGel will find use for women who've reached menpause through aging, rather than surgery.

The CNNMoney article quotes an analyst as saying that he hasn't heard if P&G will reapply to get Intrinsa approved in the U.S.