Unsafe Drugs: March 2007 Archives

Merck Fights Class Action Brought by Insurers

A lawyer for Merck & Co. argued that health insurers and union health plans should not be allowed to sue Merck & Co. for the money that they paid for Vioxx prescriptions. New Jersey State Superior Court Judge Carol Higbee, allowed class-action status to Vioxx lawsuits in July 2005. A state court decided in March 2006 that insurance companies could pursue a lawsuit against Merck, leading to Merck's appeal. Such a lawsuit could possibly cost Merck more than $15 billion.

Merck Fights Vioxx Class Action Suit Brought by Insurers

John Beisner, Merck's lawyer, told judges that health insurance companies each used different information and made their own decisions as to whether their plans would cover Vioxx. Beisner added that consumer fraud laws in the state in which a lawsuit was filed should apply to the lawsuit, as opposed to using New Jersey law in each case. "It would be a radical departure from how the Consumer Fraud Act has been interpreted previously," said Beisner.

Posted by Patricia Bowling at 11:52 AM | Permalink

Witness Says Vioxx Did Not Cause Death

Dr. Jerome Cohen, a professor of medicine at the St. Louis University of Medicine, testified that "there is not sufficient evidence to prove Vioxx causes heart attacks after taking it for 20 months." Cohen testified in the case of Patricia Schwaller. Schwaller had been taking Vioxx for 20 months before she suffered a fatal heart attack in August 2003 at the age of 52.

Merck witness says Vioxx did not cause death

Schwaller's estate and her husband, Frank Schwaller, are suing Merck & Co., saying that Vioxx was to blame for Schwaller's heart attack. Vioxx was a painkiller often prescribed to treat arthritis symptoms. Cohen testified that the lawsuit filed on Schwaller's behalf was without merit because Schwaller had a number of other risk factors for heart attacks, including the fact that she was morbidly obese. Vioxx was withdrawn from the market in 2004.

Posted by Patricia Bowling at 11:12 AM | Permalink

FDA Limits Role of Advisers in Industry

Advisers to the U.S. Food and Drug Administration who are given money from a drug or a device maker will be blocked from voting on whether to approve that company's products. The new rules were announced on Wednesday. Doctors who are given more than $50,000 from a company, or a competitor of that company, whose product is under review, will not be allowed to serve on review committees. However, those who are given less than $50,000 in a prior year will be allowed to join a committee and participate in discussions.

FDA Rule Limits Role of Advisers Tied to Industry

The FDA's acting deputy commissioner, Randall W. Lutter, said that a "significant number" of the agency's present advisers would be affected by the new policy. “The $50,000 threshold is something that we think strikes an appropriate balance between” getting smart advisers and reassuring the public that their advice is not tainted," Lutter said.

Posted by Patricia Bowling at 10:44 PM | Permalink

Lawmakers Criticize the FDA

Top U.S. lawmakers criticized the Food and Drug Administration for its recent problems in handling drug safety. The hearing looked at the FDA's handling of Ketek, prescription anti-depressants, and Vioxx. The hearing discussed accusations that the FDA hid research that suggested these drugs to be dangerous. Representative Bart Stupack, D-Michigan, asked whether the FDA really is working for the American people.

Lawmakers Blast FDA for Censorship, Negligence Regarding Unsafe Drugs

"With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," Stupak asked. "One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?" An FDA whistleblower said that the FDA has not improved its ability to protect Americans from dangerous drugs.

Posted by Patricia Bowling at 10:31 PM | Permalink

Antibiotics Overprescribed for Sinus Infections?

U.S. researchers say that doctors are overprescribing antibiotics in the treatment of sinus infections. The study was published in the March issue of Archives of Otolaryngology-Head & Neck Surgery. Hadley J. Sharp and colleagues at the University of Nebraska Medical Center said that 82 percent of acute sinus infections and about 70 percent of chronic sinus infections. Such data is worrisome because most sinus infections are caused by viruses and antibiotics only can kill bacteria.

Too Many Antibiotics Prescribed For Sinus Infections

The researchers looked at national data from 1999 to 2002 to determine which drugs were being prescribed for sinus infections by general practitioners, outpatient, and emergency departments. The researchers summed up their discoveries by saying that "the most frequently recommended medications for treatment of both acute and chronic rhinosinusitis are antibiotic agents, followed by antihistamines; nasal decongestants; corticosteroids; and antitussive, expectorant and mucolytic agents, respectively".

Posted by Patricia Bowling at 10:12 PM | Permalink

Warnings Strengthened on Sleeping Pills

The warnings on prescription sleeping pills will be strengthened on all sleeping pills because they can potentially cause sleep-driving, say federal officials. People affected by sleep-driving get up in the middle of the night to go for a drive and later have no memory of having done so. Rep. Patrick Kennedy, who crashed his car last year after taking Ambien, helped bring sleep-driving into public awareness. While the Food and Drug Administration doesn't say how many cases of sleep-driving can be linked to insomnia drugs, neurology chief Dr. Russell Katz says that the agency has found more than a dozen reports and is concerned that many go uncounted.

Sleeping Pills Can Cause "Sleep Driving"

Katz says that considering the fact that millions of people are prescribed insomnia drugs, the condition is rare. However, because the problem is so dangerous, he says it is important that those who are taking the drugs be made aware of the dangers. Doctors will receives letters alerting them to the new regulations next week.

Posted by Patricia Bowling at 12:31 PM | Permalink

Obesity Surgery Linked to Neurological Condition

Wernicke encephalopathy has been linked to weight-loss surgery, especially in younger women. Wernicke encephalopathy typically is seen in severe alcoholics and in those with a thiamine deficiency. It affects the brain and nervous systems, and has symptoms including double vision, aberrations in eye movement, unsteadiness while walking, memory loss, and hallucinations. The lead researcher of the study, Dr. Sonal Singh, says that it is unclear how common the condition is in those who have had surgery for obesity.

Neurological condition linked to obesity surgery

Singh says that the condition occurs more frequently in those who stop taking vitamin supplements or become too prone to vomiting to actually absorb nutrients from the vitamins. If recognized soon enough, the condition can be treated with thiamine injections. Those who have obesity surgery should watch for symptoms in the weeks following surgery, says Singh. "We're not saying to people 'Don't get the surgery.' But I think this is a risk that has to be considered now in the equation when people are deciding," Singh said.

Posted by Patricia Bowling at 01:28 AM | Permalink

Are Pet Drugs Safe?

Veterinarians and pet owners are beginning to express concerns over the safety and effectiveness of animal medications. Over 700 drugs have been approved for use on animals, but many other drugs are used legally without official approval. Many animal drugs were first developed for people. However, there is an increasing awareness that what works in people may not work in animals and even what works in one breed of animal may not work with another animal of the same species but of a different breed.

Pet Drugs Are Subject of Safety Fears

Additionally, animals are not able to say if a drug makes them feel sicker. " I can't tell until you see something physical," said Laurryn Simpson, who founded dogadversereactions.com. Since the year 2000, reports of side effects in animals taking drugs have gone up by about 90%; the Food and Drug Administration credits this to the growth of new kinds of drugs and to a greater understanding of side effects of animal drugs. Lawsuits have been filed against drug companies; in 2004, Pfizer gave $1,000 apiece to 300 pet owners to settle a lawsuit over use of its drug Rimadyl.

Posted by Patricia Bowling at 12:07 PM | Permalink

Banned Additives In Children's Medicines?

Young children commonly are given medicines that contain artificial dyes, sweeteners, and preservatives that are supposed to be banned from the food and drink of those under three years old. Data from the Food Commission shows that only one of 41 medications for children was free of additives. Additives can lead to undesired allergic reactions with symptoms such as rashes, eye irritation, stomach upsets, and diarrhea.

Banned Additives in Children's Medicines

Many of the varieties of medicines looked at by the Food Commission are commonly found in family medicine cabinets. Researchers admit that additives are needed in many medicines in order to make the medicine taste good for young children, but they say that the quality of the additives is of concern. “While many children will be able to consume these products safely, there will be those who will suffer allergic reactions to these additives,” said Ian Tokelove, the spokesman for the Food Commission.

Posted by Patricia Bowling at 11:47 AM | Permalink

Anemia Drugs Unsafe?

The Food and Drug Administration cautions that erythropoietins, which are anemia-fighting drugs, are being used so aggressively that they may actually be harming some patients. Studies have indicated that when doctors use the drugs to "cure" the anemia that frequently is seen in cancer and kidney-failure patients, many of these patients suffer from complications and die sooner. Some doctors are believed to be using erythropoietins at doses higher than those approved by the FDA; doctors are permitted to do this. Karen Weiss, a physician and an FDA official, said that many feel that "more is better."

Anemia Drug May Harm Some Patients, FDA Says

Erythropoietins are sold under the names Epogen, Procrit, and Aranesp and will now carry a black-box warning, which says that the lowest dose possible should be used. Studies have shown that when erythropoietins are prescribed at high levels, tumors grow faster in those who are undergoing radiation treatment for throat cancer. Women who had metastatic breast cancer and were undergoing chemotherapy in conjunction with erythropoietin use died more quickly.

Posted by Patricia Bowling at 10:55 AM | Permalink

FDA Warns Drugmakers Over Unapproved Headache Drugs

The U.S. Food and Drug Administration has ordered 20 drug companies to stop marketing unapproved drugs to fight headaches. Eight drug makers were sent warning letters, including Ivax Pharmaceuticals and Novartis AG's Sandoz unit. While the unapproved headache drugs in question contain the active ingredient ergotamine tartrate, which is the same active ingredient found in other approved drugs for headaches, these drugs have been produced and distributed without the FDA's approval.

FDA Warns Drugmakers Over Unapproved Headache Drugs

"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval. Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," said Deborah Autor, from the FDA, adding that fewer than 2 percent of medications are unapproved.

Posted by Patricia Bowling at 09:17 PM | Permalink

Off-Label Drug Use Common in Kids

The largest study to date to look at the use of off-label drug usage in a pediatric setting has found that nearly 80 percent of hospitalized children are given drugs that have been only approved for adults. The researchers who led the study say that the pharmaceutical industry and the Food and Drug Administration need to address the findings, which will appear in the March issue of the Archives of Pediatrics and Adolescent Medicine.

Off-Label Use Common in Kids

Samir Shah, the lead author of the study who also is a pediatrician specializing in infectious diseases at The Children's Hospital of Philadelphia, said that "when almost 80 percent of patients receive a drug off-label, that`s a situation that is unacceptable." The major concern about off-label drug use in children is that the drugs' effects have not been studied in children to fully know if they have adverse effects. The FDA says that it was aware of how widespread off-label drug use is in children and was working to address the issue.

Posted by Patricia Bowling at 09:00 PM | Permalink

ADHD Drug Warnings Too Late for Many

Even though manufacturers of drugs used to treat attention disorders have known for a long time about the serious health risks linked to the medications, it was not until February 21, 2007 that the Food and Drug Administration finally mandated that drug companies develop Patient Medication Guides in order to teach patients about adverse psychiatric effects associated with Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin, Strattera, and the patch and chewable versions of these drugs.

ADHD Drug Warnings Come Too Late For Many

Between January 2000 and June 30, 2005, the FDA saw about 1,000 cases of psychosis or mania that could be linked to the ADHD drugs in its database and in the databases from the drug companies. A large number of the cases were seen in children who were under 10 years old; hallucinations are rare in this age group. "The predominance in young children of hallucinations, both visual and tactile involving insects, snakes and worms is striking, and deserves further evaluation," noted an FDA report called "Adverse Events Associated with Drug Treatment of ADHD."

Posted by Patricia Bowling at 01:23 PM | Permalink

Defibtech Recalls Defibrillators Worldwide

Defibtech, LLC, has begun a worldwide voluntary recall of the Lifeline AED and ReviveR AEDTM external defibrillators. The recall affects all machines with software versions 2.002 and earlier because the self-test options on these devices may cause a previously detected low battery condition to become cleared. In cases of low battery, the defibrillator may be unable to deliver a shock in order to resuscitate a patient.

Defibtech Recalls Lifeline and ReviveR Automated External Defibrillators Worldwide

Defibtech notified affected distributors and customers by letter on February 22, 2007. The need for the recall was determined after three reports of malfunctions from end users. A maintenance program has been devised by the company that should establish whether the unit is functional until Defibtech is able to create a software upgrade to solve the problem. The Food and Drug Administration has determined that this is a Class I recall; Class I recalls are the most serious kind of recall and are declared in cases where malfunction can result in serious injury or death.

Posted by Patricia Bowling at 12:53 PM | Permalink

Bausch & Lomb Recalls Contact Solution

Bausch & Lomb has recalled over one million bottles of ReNu MultiPlus contact lens solution after excess levels of iron were discovered in the bottles. While no injuries were reported in users of the contact solution, this recall possibly will deal another blow to Bausch & Lomb; last year the company ceased production of its Renu with MoistureLoc solution because the solution was linked to a blinding fungus.

Bausch & Lomb Issues Another Recall

Christopher Cooley, an analyst with FTN Midwest Securities Corp., says that this recall "does make one question a bit their internal quality systems." The excess iron in the MultiPlus solution may cause the solution to become discolored and to have a shortened shelf life. Barbara Kelley, a Bausch & Lomb company spokeswoman, said that the recall was related to a single batch of raw materials and that the risk to consumers was "extremely low" because "virtually all the product has already been used."

Posted by Patricia Bowling at 12:16 PM | Permalink

Did Merck Hide Drug's Risks?

A lawyer told jurors that drug-manufacturer Merck ignored warnings and tried to cover up risks associated with Vioxx. These claims came during the opening statements of Andy Birchfield, who is an attorney for Patricia Schwaller, who died in August 2003 from a heart attack after taking Vioxx for 20 months. The case has drawn nationwide attention thus far because tort reform activists say that the case is being heard in one of the worst venues for corporate defendants.

Merck Hid Drug's Risks, Lawyer Says in Trial Here

Merck pulled Vioxx from the market in 2004 after a study linked Vioxx, a Cox-2 inhibitor, to a significant increase in risk for heart attack. Merck has long denied liability and says they will fight each of the 27,000 suits against the company. Schwaller's family is expected to ask for tens of millions of dollars in damages. "She should not have been taking Vioxx," Birchfield told the jurors. "She wouldn't have been (taking it) if Merck had done the right thing."

Posted by Patricia Bowling at 12:01 PM | Permalink

Philips Given Warning by FDA

Philips NV confirms that it was issued a warning by the Food and Drug Administration because of problems with its external defibrillators. Jayson Otke, a company spokesman, said that the FDA sent Philips a warning letter on January 29, but that the company quickly responded to the FDA's concerns with measures that Philips is taking to address the concerns. Otke said that more training will be provided for employees who inspect the component parts and that the specifications for parts will be reviewed with suppliers.

Philips issued warning by FDA over problems with defibrillators

Philips voluntarily recalled 2,000 defibrillators after the FDA conducted a routine inspection of a U.S. facility. The external defibrillator market makes up less than 1 percent of Philips' global sales.

Posted by Patricia Bowling at 11:29 AM | Permalink

Vitamins May Increase Risk of Death

Beta carotene and vitamins A and E may raise the risk of death, says a review of 68 studies. The 68 studies looked at nearly a quarter of a million people. However, the review is being criticized because it looked largely at studies on people who already were chronically ill before they began taking supplements. The report only looked at synthetic supplements and not at fruits and vegetables. The review was not able to point to any biomechanical mechanism that would account for the increased risk; however, the study did suggest that "by eliminating free radicals from our organism, we interfere with some essential defensive mechanisms."

Vitamins May Increase Risk of Death-Study

Antioxidants are thought to fight free radicals, which are atoms or groups of atoms that are formed in such a way that they can cause cell damage. The study says that death risk was at least 5% higher in those who took supplements. "Beta carotene, vitamin A, and vitamin E given singly or combined with other antioxidant supplements significantly increase mortality," the study concluded.

Posted by Patricia Bowling at 03:25 PM | Permalink

Performance-Enchancing Drugs Compromise Health

Athletes who use a difficult-to-detect drug in order to enhance their performance risk serious health problems. Human Growth Hormone has seen a rise in popularity recently in cheating athletes because it occurs naturally and consequently is difficult to detect through drug testing. However, new research says that use of the substance can lead to diabetes. Because many athletes already have some sense of this risk, they are taking insulin as a precautionary measure and consequently risking cancer and comatisation.

Doping Athletic Cheats Risk Health

Dr. James Young said he hadn't realized the risk that doping posed until a 36-year-old professional body-builder and gym-owner came to him with abdominal pain. Tests showed that he had acute renal failure, deranged liver function, and hyperglycemia; these symptoms typically are only seen in those with diabetes. Dr. Young said, ""It was a case of diabetes, believed to be the first reported case first reported case precipitated by recreational growth hormone misuse. It is therefore reasonable to assume that administration of growth hormone, could lead to hyperglycaemia."

Posted by Patricia Bowling at 01:20 PM | Permalink

High Blood Pressure Linked to Painkillers

A new study published in the Archives of Internal Medicinesays that men who use painkillers on a regular basis often have higher blood pressure compared to men who do not use painkillers on a regular basis. Researchers from Harvard Medical School looked at 16,031 male health profession of average age 65 with no history of high blood pressure and followed them over a four year period. Painkillers looked at here acetaminophen and nonsteroidal anti-inflammatories.

High Blood Pressure Linked to Painkillers

At the end of the four year period, 1,968 of the men had problems with hypertension. The researchers say that the men who took painkillers regularly were 38% more likely to develop high blood pressure than men who did not take painkillers at all. The risk of developing hypertension was higher in those who had taken acetaminophen. The researchers concluded that the use of non-narcotic analgesics is independently associated with a moderate increase in blood pressure.

Posted by Patricia Bowling at 01:04 PM | Permalink

FDA Orders ADHD Drug Advisories

The Food and Drug Administration has ordered that all attention deficit hyperactivity disorder drugs come with guides to educate patients about the potential for cardiovascular risks and adverse psychiatric effects. The new guides will be for the education of patients, families, and caregivers of those with ADHD. They will be available at pharmacies or clinics were the drugs are distributed. Steven Galson, M.D., the director of the FDA's Center for Drug Evaluation and Research, said that "medicines approved for the treatment of ADHD have real benefits for many patients, but they have serious risks as well."

FDA Orders ADHD Drug Advisories for Patients

The patient guides are a consequence of the FDA's May 2006 directive to ADHD drugs to "revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events." The FDA says it has heard reports of serious cardiovascular adverse effects in patients taking standard doses of ADHD medications, including instances of sudden death in patients who had underlying cardiac disease or structural cardiac abnormalities.

Posted by Patricia Bowling at 12:54 PM | Permalink

FDA Puts Stronger Warning on Xolair

The U.S. Food and Drug Administration has said that Xolair, an injected asthma drug, needs to have the strongest warning possible on its label. The new warning will alert to the possibility of anaphylaxis as a side effect of taking the drug. Anaphylaxis is a sudden, life-threatening allergic reaction that can cause trouble breathing, tightness in the chest, dizziness, fainting, itching, hives, and swelling of the mouth and throat. One study says that a drug regime including Xolair helps cut emergency medical visits.

FDA Mandates Stronger Warning on Asthma Drug Xolair

The FDA has asked Genentech, manufacturer of Xolair, to update the warning label on Xolair and to provide a patient guide with information on anaphylaxis. "It is probably going to affect prescribing in a very minor way," said Dr. Andrew Colin, director of pediatric pulmonology at the University of Miami Miller School of Medicine. "This cannot be viewed as a routine medication at this point in time. It's reserved for the severe or resistant patient, so I do not think that these extra precautions are really going to have a huge impact."

Posted by Patricia Bowling at 11:52 PM | Permalink

March 30, 2007

Merck Fights Class Action Brought by Insurers

March 29, 2007

Witness Says Vioxx Did Not Cause Death

March 28, 2007

FDA Limits Role of Advisers in Industry

March 27, 2007

Lawmakers Criticize the FDA

March 26, 2007

Antibiotics Overprescribed for Sinus Infections?

March 23, 2007

Warnings Strengthened on Sleeping Pills

March 22, 2007

Obesity Surgery Linked to Neurological Condition

March 21, 2007

Are Pet Drugs Safe?

March 20, 2007

Banned Additives In Children's Medicines?

March 19, 2007

Anemia Drugs Unsafe?

March 16, 2007

FDA Warns Drugmakers Over Unapproved Headache Drugs

March 15, 2007

Off-Label Drug Use Common in Kids

March 14, 2007

ADHD Drug Warnings Too Late for Many

March 13, 2007

Defibtech Recalls Defibrillators Worldwide

March 12, 2007

Bausch & Lomb Recalls Contact Solution

March 09, 2007

Did Merck Hide Drug's Risks?

March 08, 2007

Philips Given Warning by FDA

March 07, 2007

Vitamins May Increase Risk of Death

March 06, 2007

Performance-Enchancing Drugs Compromise Health

March 05, 2007

High Blood Pressure Linked to Painkillers

March 02, 2007

FDA Orders ADHD Drug Advisories

March 01, 2007

FDA Puts Stronger Warning on Xolair