Unsafe Drugs: February 2007 Archives

$3M Awarded in Prempro Case

A Philadelphia jury ruled that Wyeth's hormone replacement therapy Prempro caused Jennie Nelson's breast cancer and awarded Nelson and her husband damages of $3 million. Wyeth says that it disagrees with the verdict and plans an appeal. The first Philadelphia jury that heard the case also ruled in Nelson's favor, but the judge threw out the verdict and declared a mistrial, leading to this trial.

Jury awards plaintiff $3 mln in Wyeth Prempro case

The original trial had awarded Nelson and her husband $1.5 million in compensatory damages. "Both times this case has been heard on terms established by Wyeth and still the juries have clearly found that Prempro causes breast cancer," said Tobias Millrood, Nelson's attorney. Nelson took Prempro for about six years before she was diagnosed with breast cancer. Consequently, Nelson had to undergo a double mastectomy and had to undergo chemotherapy and radiation treatments.

Posted by Patricia Bowling at 11:49 AM | Permalink

Internet Drug Scam Sending Anti-Psychotics to Customers

The Food and Drug Administration says that consumers who believed they were buying sleep aids, antidepressants, and other drugs over the Internet were instead shipped a powerful anti-psychotic. The FDA said that many consumers took the schizophrenia drug, haloperidol, after ordering medications such as Ambien, Xanax, Lexapro, and Ativan.

FDA: Internet Drug Scam Sends Anti-Psychotics to Customers, Sending Some to Hospital

Analysis of the pills, which were packaged in plastic bags and mailed in envelopes with Greek postmarks, suggested that the pills contained haloperidol. The FDA said that it had received reports of consumers having difficulty breathing, muscle spasms, and muscle stiffness after taking the pills. The FDA still cautions against ordering prescription medications over the internet.

Posted by Patricia Bowling at 12:32 PM | Permalink

FDA Cites Abraxis for Possible Plant Contamination

Federal regulators cautioned drug maker Abraxis Bioscience that its manufacturing procedures do not do enough to keep products sterilized. The Food and Drug Administration sent Abraxis a letter in December saying that Abraxis has not established procedures to guarantee sterilization of drugs made at its Illinois plant. Consequently, the company is in violation of federally enforced manufacturing standards. The warning letter told Abraxis to give the FDA a plan to increase sterilization within 15 days.

FDA cites Abraxis for plant problems

The FDA found problems after discovering that Abraxis workers did not uncover or record instances in which contamination had occurred at the plant. Abraxis spokeswoman Christine Cassiano said that the company has given the FDA a revised plan and has been working to address problems since receiving the FDA's letter. Abraxis is located in Los Angeles and makes generic injectable drugs. The company's annual revenue in 2005 was $518 million.

Posted by Patricia Bowling at 12:09 PM | Permalink

FDA Blows Zyprexa Whistle

Eli Lilly currently is being sued by attorney generals in seven states for fraud because of the way in which they market their drug Zyprexa. Zyprexa is FDA approved for the treatment of schizophrenia and bipolar disorder, but can increase a patient's risk for diabetes and severe weight gain drastically.

FDA Blows Zyprexa Whistle

It recently has come out that Eli Lilly encouraged their drug representatives to promote Zyprexa for non-FDA approved, "off-label," uses. Other antipsychotic medications also are currently being reviewed to determine if they also cause excessive weight gain.

Posted by Patricia Bowling at 12:31 PM | Permalink

FDA Warns about Merck Vaccine

The Food and Drug Administration is notifying health-care providers and consumers that 28 cases of infants suffering a serious bowel condition have been reported following injection with Merck's new vaccine against the Rotavirus. About 3.5 million doses of Merck's RotaTeq have been given in the United States and while the 28 reported cases of illness does not exceed what would be expected, the FDA is releasing the information to encourage those with similar complaints to come forward.

FDA warns about Merck vaccine

The condition is known as intussuction and occurs when the intestine is blocked or twisted. The same problem led to the 1999 recall of Wyeth's RotaShield. Rotavirus causes serious diarrhea and is a leading cause of illness for babies.

Drug-Coated Stents Don't Reduce Risk of Heart Attacks

The most thorough studies to date on drug-coated stents show that the commonly used heart devices are no better at preventing heart attacks and death than the older, cheaper devices that they replaced. In some cases, the new devices proved even more dangerous. Since their introduction in 2003, the drug-coated stents have become one of the fastest-selling medical devices in history. However, concerns about the safety of the devices have begun to arise because patients with drug-coated stents appear to have a higher risk of developing arterial blood clots.

Drug-coated stents don't cut risk of heart attacks

Studies show that drug-coated stents carry one clear benefit: patients who receive them are less likely to make return trips to the hospital for repeat heart-cleaning procedures. However, the long-term benefits of the stents are less clear. A Swedish study showed that patients with drug-coated stents were more likely to die than those with bare-metal ones. Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston says that the recent studies will affect the use of drug-coated stents: "The decision to put in a drug-eluting stent is now a decision, where before it was used in almost any case."

Posted by Patricia Bowling at 12:25 PM | Permalink

Ketek Warning Labels Revised

The U.S. Food and Drug Administration has revised the warning labels on the antibiotic Ketek in order to improve the safety of patient use. Ketek is the brand name of Sanofi-Aventis's drug Telithromycin. Ketek was approved by the FDA for the treatment of acute bacterial infections associated with sinusitis and chronic bronchitis. The is the second time in the last year that Ketek's labeling has been changed.

FDA Revises Label Warnings on the Antibiotic Ketek

While Ketek will retain its status as being FDA approved for the treatment of acquired pneumonia of "mild to moderate severity," it now will carry a black box label, the most severe level of warning given by the FDA. The new label will also caution that those with the muscle weakness autoimmune disease myasthenia gravis should not take the drug and will give a stronger warning about the potential side effects, including "visual disturbances" and "loss of consciousness." Dr. Steven Galson, the Director at the Center for Drug Evaluation and Research said that "action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give health care providers the most up-to-date prescribing information."

Posted by Patricia Bowling at 12:07 PM | Permalink

Lawmakers Question the FDA

At a hearing on the Food and Drug Administration's drug safety oversight, U.S. lawmakers criticized the FDA's monitoring of a Sanofi-Aventis antibiotic and other prescription drugs. Lawmakers say that the FDA muffles concerns about drug risks when top managers disagree, citing problems with Sanofi's antibiotic Ketek, Merck's drug Vioxx, and antibiotics made by several companies. Representative Bart Stupak, a Michigan Democrat, said that "With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug."

Lawmakers blast FDA drug safety oversight

"One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?" Stupak also said. Congress is currently considering legislation that would strengthen the FDA's oversight of drug side effects.

Posted by Patricia Bowling at 11:51 AM | Permalink

Heart Surgery Drug Boosts Death Risk?

Patients who are given aprotinin, a drug that is used to limit blood loss in heart bypass surgery, are at a greater risk of dying over the next five years than those given other medications. Recent research links aprotinin to increased risk of kidney failure, heart failure, and stroke. Dr. Dennis T. Mangano, the director of the Ischemia Research and Education, said that "Our present findings deal with death. The death rate for aprotinin patients far outstrips that for the other two drugs."

Heart Surgery Drug May Boost Death Risk

The study looked at long-term survival of nearly 3,900 heart patients who underwent coronary artery bypass surgery. The five-year death rate for patients given aprotinin was 20.8% compared to 15.8% for those given aminocaproic acid, and 14.7% for those given trenexamic acid. Aprotinin was approved by the FDA for use in high-risk cardiac surgery patients in 1993.

Posted by Patricia Bowling at 12:19 AM | Permalink

AIDS Healthcare Group to Sue Pfizer

Reuters reports that the AIDS Healthcare Foundation, AHF, plans to file a lawsuit against the pharmaceutical company Pfizer for promoting use of its erectile dysfunction drug for recreational purposes. AHF says that Pfizer's advertisements for the drug have increased risky sexual behavior, which potentially leads to increases of HIV and other sexually transmitted diseases among men. The group says that "Pfizer has created and contributed to the perception of Viagra as a safe, sexy, lifestyle, recreational drug to be frequently used regardless of the degree, or even existence of."

AIDS Healthcare Foundation To File Lawsuit Against Pfizer for Allegedly Promoting Recreational Use of Erectile Dysfunction Drug

AHF cites several recent Pfizer advertisements, such as a 2005 newspaper ad that asked "What are you doing on New Year's Eve?" and another ad that ran during the 2006 Super Bowl that told men to be "this Sunday's MVP." AHF President Michael Weinstein says that the ads portray Viagra as a party drug that can improve sexual performance in healthy men; this claim has not been approved by the Food and Drug Administration.

Posted by Patricia Bowling at 11:53 PM | Permalink

Some Birth Control Raises Clot Risk

Public Citizen, a consumer group says that "third-generation" oral contraceptives carry a significantly higher clot risk than most birth control pills. "Third-generation" oral contraceptives contain a kind of progestin called desogestrel; Public Citizen says that these pills carry double the risk of blood clots compared to other oral contraceptives.

Some Birth Control May Raise Clot Risk

Taking any birth control pill increases the risk of blood clots that can potentially travel to the lungs and kill. It is a side effect of the hormones in the pill, estrogen and progestin. About 15 users per 100,000 taking the second-generation pills will develop blood clots compared to 30 blood clots per 100,000 users with the third-generation pills. This is not a new concern; labels of desogestrel-containing pills already had a warning to reflect the risk and in 1995 British drug regulators warned of the increased dangers before desogestrol-containing pills hit the U.S. market. "FDA will carefully review the petition," said agency spokeswoman Susan Cruzan.

Posted by Patricia Bowling at 11:15 AM | Permalink

Hernia Mesh Patch Recall

The Food and Drug Administration announced that it has upgraded the recall of the Bard Composix Kugel Mesh Hernia Patch to "class 1" because the patches can cause death or serious health problems. Patients using the device should seek medical attention if they have symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unexplained side effects. Patients who underwent surgery that used mesh patches are advised to contact their hernia surgeons or the hospital where their hernia surgery took place to find out if the Composix Hernia patch was used in their surgery.

Hernia Mesh Patch Recall - FDA Warns of Death and Serious Health Problems

The Composix Kugel Mesh Patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that occurs after surgery. The patch is held open by a "memory recoil ring" that allows the patch to be folded for insertion and it then will later open and lay flat once surgery is completed. Johnson Law Firm Attorney Steven Johnson said of the patch: "Adequate testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain."

Posted by Patricia Bowling at 03:34 PM | Permalink

Teen Blames Stroke on Banned Supplement

Joseph Stern was a dedicated and promising young football player. "I wanted to be on varsity as a junior," he said. "To me, that was a big accomplishment. But unfortunately, I never got to be able to accomplish it." However, his dreams never will be fulfilled because Stern suffered a stroke at the age of 16. Stern and his parents believe that his stroke likely was caused by a supplement he was taking; an ingredient in "ma huang" also known as "ephedra."

Teen Suffers Stroke, Blames Banned Supplement

The Sterns have filed a lawsuit against a north Dallas store where Joseph bought the product, alleging that the storekeepers led Joseph to believe that the product was safe and without health risks. Joseph says he was told that the supplement would "make him faster; lose weight; get stronger." However, the Food and Drug Administration banned the substance years ago after finding that the herbal supplement raises blood pressure and places stress on the circulatory system and has been linked to heart attacks and strokes. The Sterns ask why the product Joseph purchased was available after the ban: store owner Marc Norsworthy says that "I'm not aware that we were selling products with Ephedra that the FDA banned."

Posted by Patricia Bowling at 01:57 PM | Permalink

Prempro Lawsuit Dismissed

A Texas judge dismissed a lawsuit against Wyeth, saying that the plaintiff received adequate information that one of the potential risks of taking Prempro is an increased risk of breast cancer. The plaintiff had filed her suit, alleging that Wyeth had "failed to warn" of the risks of Prempro. The judge ruled that the Food and Drug Administration's drug labeling preempted this claim.

Wyeth Prempro Lawsuit Dismissed

A Philadelphia judge recently gave an Arkansas woman $1.5 million in damages after a jury decided that Prempro had caused her breast cancer. The jurors decided that Prempro was a "factual" cause of the woman's cancer and that Wyeth had not given adequate warnings about cancer risk. Approximately 5,000 lawsuits have been filed against Wyeth over their hormone replacement drugs Prempro and Premarin. Approximately 6 million women took the drugs before a 2002 medical study showed a strong link between the drugs and cancer.

Lucentis Increases Stroke Risk in Elderly

Genentech Inc. has sent letters to 1,500 retinal specialists that their drug Lucentis looks to increase the risk of stroke in elderly patients, especially if they have suffered from previous strokes. Lucentis is used to treat wet age-related macular degeneration. Genentech has classified the letter as a "proactive effort" after an interim analysis of a 5,000 patient trial showed that 1.2% of patients who were given the standard dose had strokes compared with only 0.3% of patients who were given a lower dose.

Genentech: Biologic Eye Drug Lucentis Ups Stroke Risk in Elderly Patients

The findings could affect Lucentis's profits; it has been Genentech's most successful product with $217 million in sales in the last three months of 2006. "We want to be open and honest with the physician community, but this is consistent with what we've seen. The FDA is aware of this, and we don't anticipate any changes to the label," a Genentech spokesperson said. Dr. Phillip J. Rosenfeld, a retina specialist in Miami said that the news likely wouldn't affect his practice: “When given a choice between 100 percent blindness or a 1 percent risk of stroke, I think most patients will choose their vision.”

Posted by Patricia Bowling at 01:47 PM | Permalink

FDA to Track Drugs More Closely

The U.S. Food and Drug Administration plans to monitor side effects of medications after they are put on the market more closely. Criticism of the FDA's regulation of the drug industry has mounted since Merck & Co. withdrew its painkiller Vioxx after Vioxx was linked to increased risk of heart attacks and strokes.

FDA to Track Drugs More Closely

The FDA plans to adopt more than 30 safety measures, some of which were announced before and don't require additional funding. In January, the FDA recommended to lawmakers that they increase fees paid by drug makers for speedy reviews of new treatments as a way to pay for other safety measures. The FDA plans to review an unspecified number of drugs after about 18 months. "They've outlined a lot of first steps that go in the right direction," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin at Madison. "There's a lot of places where there's some daylight between their response and our recommendations." Charo was a part of the committee that recommended that the FDA overhaul their review process.

Posted by Patricia Bowling at 01:31 PM | Permalink

FDA Cautions Against Ultrasound Baby Photos

The Food and Drug Administration is warning that taking ultrasound photos of unborn babies poses an unnecessary risk to the baby. The FDA is concerned about companies who are marketing ultrasounds as a way to create prenatal portraits. Businesses with names like Fetal Fotos, Peek-a-Boo, Womb with a View, and Baby Insight are becoming increasingly more common around the United States, even showing up in shopping malls. They sell "keepsake videos" that use ultrasound technology in order to show the surface anatomy of babies developing.

FDA Cautions Against Ultrasound "Keepsake" Images

However, while ultrasounic fetal scanning generally is considered a safe procedure if performed properly, laboratory studies have shown evidence that ultrasounds can affect tissue, such as jarring vibrations and a rise in temperature. Ultrasounds conducted by people working at malls can be dangerous because staff may not be adequately trained and the medical community agrees that ultrasounds only should be conducted when medically necessary. Mel Stratmeyer, from the FDA's Office of Science and Technology, says that most animal studies have not found any fetal harm with low-dose ultrasound exposure, "but the issue of keepsake videos has to be that if there's even a possibility of potential risk, why take the chance?"

Posted by Patricia Bowling at 01:13 PM | Permalink

Wyeth Loses Prempro Trial

A state jury found Wyeth's hormone replacement therapy drug Prempro was responsible for an Arkansas woman's breast cancer and said that the U.S. drugmaker must pay $1.5 million in damages. The jury in the case decided that Wyeth was negligent in not providing more information about the increased breast cancer risk associated with Prempro.

Wyeth Loses Prempro Trial, to Pay $1.5 Million

The jury will return to decide punitive damages; they also decided that Wyeth's conduct was "malicious, wanton, willful or oppressive or showed reckless indifference to the interest of others" because of its lack of warnings about its HRT drugs. Wyeth currently faces about 5,000 product liability lawsuits involving its hormone replacement drugs. "Wyeth protected their bottom dollar instead of protecting the patients," said Zoe Littlepage, attorney for plaintiff Mary Daniel, the Arkansas woman whose breast cancer is blamed on Prempro.

Posted by Patricia Bowling at 09:30 PM | Permalink

Anti-Clotting Drugs Recommended with Heart Stents

Heart patients who have drug-coated stents implanted to hold open blocked coronary arteries should stay on anti-clotting drugs for at least a year. The advisory, put together by several doctor groups, said that doctors should tell their patients to take anti-clotting drugs like Plavix and aspirin for a year to reduce the risk of dangerous clotting. The long-term safety of Plavix in stent patients has not yet been established.

Anti-clotting drugs recommended for use on heart stents

Drug-coated stents are usually chosen over bare metal stents because they slowly release medication that reduces the risk of arteries re-clogging, which can lead to more surgery. However, drug-eluting stents have been linked to a small but significant risk of clotting. Dr. Cindy Grines, who chairs the advisory committee, said that following public release of the study, "patients are very informed about this and most are asking the question before we even begin the conversation with them, which is good."

Posted by Patricia Bowling at 07:44 PM | Permalink

Advisors Say No New Birth Control Pill Rules

Federal health advisers recommend that the government not set failure limits on birth control pills because it could prevent less-effective but still beneficial contraceptives from being available to women. The newer, lower-dose birth control pills are less effective in preventing pregnancy than those first approved in 1960. However, the newer oral contraceptives have fewer side effects and offer other health benefits. This has caused indecision on the part of federal health officials on the need to set a finite failure rate that would be unacceptably high for newer pills.

Advisers Nix New Birth Control Pill Rules

Today's generation of oral contraceptives have less estrogen and progestin. These pills have lower risk of leading to blood clots, strokes, and other occasionally deadly side effects. However, as side effects have dropped, pregnancy rates have upped. In the last decade, the FDA has approved some pills with failure rates exceeding two pregnancies per 100 women. That is twice the pregnancy rate of the 1960s. However, lower dose pills with higher pregnancy rates can be useful for women looking to regulate their monthly periods or to help with acne. Dr. Charles Lockwood of Yale University, acting chairman of the FDA's reproductive health drugs advisory committee, said that allowing less effective pills on the market can increase the options for women and doctors. "We don't want an arbitrary number to be ascribed," said Lockwood.

Posted by Patricia Bowling at 07:15 PM | Permalink

February 28, 2007

$3M Awarded in Prempro Case

February 27, 2007

Internet Drug Scam Sending Anti-Psychotics to Customers

February 26, 2007

FDA Cites Abraxis for Possible Plant Contamination

February 23, 2007

FDA Blows Zyprexa Whistle

February 22, 2007

FDA Warns about Merck Vaccine

February 21, 2007

Drug-Coated Stents Don't Reduce Risk of Heart Attacks

February 20, 2007

Ketek Warning Labels Revised

February 19, 2007

Lawmakers Question the FDA

February 16, 2007

Heart Surgery Drug Boosts Death Risk?

February 15, 2007

AIDS Healthcare Group to Sue Pfizer

February 14, 2007

Some Birth Control Raises Clot Risk

February 13, 2007

Hernia Mesh Patch Recall

February 12, 2007

Teen Blames Stroke on Banned Supplement

February 09, 2007

Prempro Lawsuit Dismissed

February 08, 2007

Lucentis Increases Stroke Risk in Elderly

February 07, 2007

FDA to Track Drugs More Closely

February 06, 2007

FDA Cautions Against Ultrasound Baby Photos

February 05, 2007

Wyeth Loses Prempro Trial

February 02, 2007

Anti-Clotting Drugs Recommended with Heart Stents

February 01, 2007

Advisors Say No New Birth Control Pill Rules