Volume 3   Issue  36                        November   2004

The 5 drugs Whose Safety was Questioned

 

Los Angles Times By Thomas H. Maugh II, November 22, 2004

Accutane

Accutane is a highly effective drug for clearing up severe acne that is resistant to other forms of treatment. Derived from vitamin A, it essentially stops the production of oil in the sebaceous glands of the skin, shrinking those glands to the size of a baby's.

The drug causes dry lips in most patients, dry eyes (which can lead to conjunctivitis) in 40 percent of patients and back pain in 30 percent of patients. Less common side effects included joint pain, headaches, itching and sensitivity to the sun.

Far overwhelming those, however, is the risk of birth defects if the drug is given to pregnant women. When the drug was first prescribed in the 1970s in France, physicians found more than 800 severely deformed babies among 1,000 births in women taking the drug.

Over the intervening years, physicians have been warned about prescribing it to women who might be pregnant, but a pre-treatment pregnancy test only recently became mandatory rather than voluntary.

The Centers for Disease Control and Prevention estimated in 1989 that there were about 4,000 U. S. women of child-bearing age with acne sufficiently severe to require the drug; experts say there are probably about 6,000 now. Nonetheless, 156,800 women received the drug in 2002 and 2003.

Bextra

Bextra is meant to relieve pain without causing the stomach damage and bleeding associated with aspirin and other nonsteroidal anti-inflammatory drugs. It is approved to treat painful menstrual symptoms, osteoarthritis and rheumatoid arthritis. There is an injectable form of the drug called parecoxib.

Bextra is a sulfonamide drug and can cause anaphylactic shock in people who are allergic to sulfa drugs. The labeling did not initially indicate that Bextra was a sulfa drug, and many allergic reactions, some of them life-threatening, occurred before the labeling was changed.

The drug is in the same class as Vioxx, which Merck & Co. took off the market in September after a study showed the drug nearly doubled the risk of heart attacks and strokes among people taking it for at least 18 months. Both drugs are known as Cox-2 inhibitors.

Last week, Dr. Garrett Fitzgerald of the University of Pennsylvania reported at a New Orleans meeting of the American Heart Association on a study of 59,000 patients showing that those who received Bextra were 2.19 times as likely to have a heart attack or stroke than those taking a placebo. Some previous studies showed no unusual risk.

Crestor

Crestor is the newest member of a family of drugs called statins that reduce cholesterol levels in the blood by blocking the synthesis of cholesterols by the body. In general, the drugs have been shown to be very effective in reducing the risk of heart attack and stroke, even in patients who do not have unusually high levels of cholesterol.

The most common severe side effect of statins is rhabdomyolysis, a potentially life-threatening deterioration of muscle tissue. One statin drug, Baycol, has already been removed from the market because it is much more likely to produce muscle damage than the other statins.

Critics charge that Crestor is more similar to Baycol than to the other statins in its potential for damaging muscles. They also say that there have been at least 29 cases of severe kidney damage associated with use of the drug.

AstraZeneca halted clinical trials of the drug in 2001 following reports of kidney damage and early stages of rhabdomyolysis among subjects receiving an 80-milligram dose. The drug is now sold in doses ranging from 5 to 40 milligrams, although there are restrictions on use of the 40-milligram formulation.

Meridia

Meridia increases the concentration in the brain of three neurotransmitters -norepinephrine, serotonin and dopamine -in an effort to decrease appetite.

Like all other diet drugs, it is only minimally effective. A review published last May showed that the average weight loss among Meridia users was only 9.8 pounds after a year of use, and much of that lost weight eventually returned after drug use was halted.

Like most drugs that affect brain chemistry, Meridia causes dry mouth, headache, insomnia and other problems. It also increases blood pressure in direct proportion to the dosage and has been associated with some heart abnormalities. There have been reports of serious cardiovascular events requiring hospitalization and some deaths associated with Meridia use.

The most dangerous side effect occurs when it is used in at the same time as other drugs that raise serotonin levels in the brain, particularly antidepressants, but also Parkinson's drugs, migraine drugs and illegal drugs, such as cocaine and ecstasy.

These drugs can combine to produce a potentially life-threatening condition called serotonin syndrome. Symptoms can include confusion, agitation, lethargy, spasms, tremors and a condition called autonomic instability that includes elevated temperature, rapid heart rate, sweating, nausea, diarrhea and dilated pupils.

An FDA advisory panel initially recommended against approval of the drug but was overruled when Abbott filed suit against the agency. The drug is currently banned in Italy and is under active investigation in France and the United Kingdom, where there have been more than 100 serious adverse reactions and two deaths.

Serevent

Serevent Salmeterol, which is used to open air passages in the lungs in the treatment of asthma, is the primary ingredient in Serevent, typically used twice a day to provide long-lasting protection against allergies and asthmas. It is not used to combat short periods of intense asthmatic activity.

The drug is probably the least problematic of those cited in the congressional testimony. The primary concern is that it can actually increase the risk of life-threatening asthma episodes and asthma deaths in some patients.

That concern arises from a large clinical trial of the drug begun by GlaxoSmithKline in 1996. The study was terminated prematurely in January 2003 because of initial indications of increased risk of death.

Although the data form the study have not yet been published, the product warning label required by FDA says that there were 13 deaths out of 13,174 patients treated for 28 weeks, compared with four deaths among 13,179 patients receiving a placebo. The risk was higher in blacks than in Caucasians, but data were not presented.

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