Unsafe Drugs: November 2006 Archives

Aleve Safe for Short Term Use

A company-funded study says that short-term use of Aleve, the over-the counter version of naproxen, appears safe and possibly even healthy for users' cardiovascular systems. Aleve is a non-steroidal anti-inflammatory drug (NSAIDs.) Other drugs of this type include aspirin, ibuprofen, and cox-2 inhibitors.

Aleve Heart-Healthy Over Short-Term

Use of Aleve does not carry risks of the cox-2 inhibitors Vioxx and Bextra. Vioxx and Bextra were associated with a significantly heightened risk for heart attacks and strokes before they were pulled from the market. Taking Aleve daily appears to reduce blood platelet activity in the same way that daily low-dose aspirin does. Lead investigator Michael Schiff said of the results: "Patients come into my office and want something for pain. They want to know if the medicine I am going to give is going to have a cardiovascular risk. This data speaks to that issue. Aleve will not be risky in that sense, and it could be cardio-protective."

Posted by Patricia Bowling at 09:09 PM | Permalink

Cox-2 Inhibitor Debate Lingers

Merck failed to calm alleviate concerns over safety issues related to cox-2 inhibitor painkillers. Merck recently published crucial data on Arcoxia, its successor drug to Vioxx. Concerns still linger over the safety of cox-2 inhibitors; Merck's drug Vioxx was withdrawn from the market in 2004 after a company study discovered that it doubled heart attack and stroke risks. Vioxx and Pfizer's Celebrex and Bextra had been called "super aspirins" for their ability as better and safer painkillers than aspirin.

Merck fails to calm cox-2 inhibitor debate

Merck currently is trying to get approval for its drug Arcoxia (etoricoxib) and is comparing the side effects of Arcoxia to those of non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, and diclofenac. However, experts who wrote an editorial in The Lancet asked "whether society should invest increasing amounts into ever larger randomised trials to address the remaining safety questions about the cardiovascular risk of Nsaids, even if logistically feasible."

Posted by Patricia Bowling at 07:42 PM | Permalink

Judge Tosses $50 Million Vioxx Award

A judge has tossed the $50 million compensatory damage award in a federal Vioxx case after ruling that the award was "grossly excessive." U.S. District Judge Eldon E. Fallon ruled that "no reasonable jury could have found" that Gerald Barnett, a retired FBI agent, was entitled to $50 million for the heart attack he suffered in 2002. Barnett's attorney, Mark Robinson, said he had not seen the ruling and was unable to comment on the ruling at this point in time.

Fallon ruled that Barnett has grounds for monetary compensation for his past and future medical bills, his pain and suffering, and other intangible losses. The new trial will be limited to the question of damages; Fallon did not overturn the jury's findings against Merck, only the monetary compensation.

Posted by Patricia Bowling at 06:46 PM | Permalink

Tamiflu Patients Need Monitoring

Health officials unveiled a new warning on the labeling of the influenza drug Tamiflu: patients taking the drug should be monitored for signs of abnormal behavior. The precaution comes after more than 100 reports of delirium, hallucinations, and other unusual psychiatric behavior were linked to children taking the drug.

FDA: Tamiflu patients need monitoring

The Food and Drug Administration said that a relationship between the drug and the unusual behavior had not been established and that the updated label merely is to "intended to mitigate a potential risk associated with Tamiflu." The previous FDA Tamiflu label warned that "seizure and confusion" had been seen in some patients. Tamiflu manufacturer Roche Holding AG responded that there was no evidence of the drug causing the rarely occurring adverse side effects.

Posted by Patricia Bowling at 06:26 PM | Permalink

Most Kids Not Getting Proper Flu Shot Dosage

A new study shows that U.S. children who got a flu shot during the 2003-2004 flu season were not given the recommended two doses. Only 12% of the children between the ages of two and eight got both doses of the trivalent inactivated influenza vaccine that are suggested for protection against the virus, said the findings from the Vaccine Safety Datalink study.

Most children not getting two doses of flu vaccine

Dr. Lisa A. Jackson of the Group Health Center for Health Studies in Seattle, Washington looked at data for 125, 928 children between the ages of 6 months and 8 years to draw the conclusion that adequate dosage was not being administered to the children. Jackson's team found that children who received their first TIV dose before mid-November had the highest compliance rates for full immunization and that this finding should "reinforce previous recommendations to target previously unvaccinated children less than 9 years of age for early vaccination, in September if possible."

Posted by Patricia Bowling at 01:36 PM | Permalink

Massive Recall of Acetaminophen

Millions of bottles of pain reliever acetaminophen are being recalled because they may contain metal fragments. Perrigo Co. sold the pills under store brands by Wal-Mart, CVS, Safeway, and more than 120 other retailers. 11 million bottles are affected by the recall, each containing varying quantities of 500 milligram capsules. There have been no reports of injuries or illness thus far.

Massive recall of acetaminophen underway

Perrigo discovered the metal pieces during quality control checks done after the company found its equipment to be wearing down prematurely. A company investigation found metal in about 200 pills of the 70 million it passed through a metal detector. Consumers who take the contaminated pills may have minor stomach discomfort or possible cuts to the mouth and throat, said the FDA, but serious injury is a very remote possibility. The recall does not affect Tylenol, the brand most commonly associated with acetaminophen.

Posted by Patricia Bowling at 01:09 PM | Permalink

Risperdal: A New Drug for Autism

Risperdal, manufactured by Janssen Pharmaceutica, has been approved by the Food and Drug Administration to treat the symptoms of autism in children and adolescents ages 5 to 16. This is the first drug that the FDA has approved to treat behaviors such as self-injury, aggression, and severe temper tantrums in autistic children. "This approval should benefit many autistic children as well as their parents and caregivers," said Dr. Steven Galson, the director of the FDA's Center for Drug Evaluation and Research.

However, not everyone is so optimistic about the drug's approval. Many doctors warn that the drug should be used only after other non-medication treatments have been tried. The National Autism Association has concerns over Risperdal because it can have side effects including drowsiness, fatigue, constipation, and weight gain. Risperdal has been on the market since 1993 and is used to treat adults with schizophrenia and bipolar disorder.

Posted by Patricia Bowling at 04:54 PM | Permalink

Oral Contraceptives Increase Breast Cancer Rate Slightly

The journal Mayo Clinic Proceedings reports that oral contraceptive use is a risk factor for premenopausal breast cancer. However, even for parous women, those who have used oral contraceptives for at least four years before their first full-term pregnancy, "the absolute risk is very small," said Dr. James R. Cerhan, from Mayo Clinic College of Medicine.

The pill ups early breast cancer risk slightly

Dr. Chris Kahlenborn, from Altoona Hospital in Pennsylvania, noted in the paper that the rate of breast cancer in premenopausal women has increased noticeably in the last few decades. While more studies are needed, the team concluded that oral contraceptives are carcinogenic; the conclusion is supported by the World Health Organization's recent classification of oral contraceptives as being a group 1 carcinogen.

Posted by Patricia Bowling at 11:55 AM | Permalink

November 30, 2006

Aleve Safe for Short Term Use

November 29, 2006

Cox-2 Inhibitor Debate Lingers

November 28, 2006

Judge Tosses $50 Million Vioxx Award

November 27, 2006

Tamiflu Patients Need Monitoring

November 10, 2006

Most Kids Not Getting Proper Flu Shot Dosage

Massive Recall of Acetaminophen

November 08, 2006

Risperdal: A New Drug for Autism

November 07, 2006

Oral Contraceptives Increase Breast Cancer Rate Slightly