FDA Official Says Five Popular Drugs Are UnSafe
WASHINGTON, DC — November 24, 2004 — The Food and Drug Administration (FDA) should either recall or severely restrict the use of five dangerous drugs, according to the agency’s own associate director of the Office of Drug Safety, David Graham. Graham was testifying at a Senate Finance Committee hearing called to discuss the FDA’s handling of the Vioxx problem. A popular drug used to treat the pain of arthritis, Vioxx was withdrawn from the market by its manufacturer in September because it increases the risk of heart attacks, strokes, and blood clots. Legislators, consumer groups, and medical experts have criticized the agency for not recalling Vioxx several years ago. (See Vioxx Side Effects Were Apparent).
“The FDA as currently configured is incapable of protecting America against another Vioxx,” Graham said (Washington Post, November 19, 2004). “The scientific standards [the FDA] applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market.” He added that the agency’s duty to review and approve new drugs sometimes conflict with safety considerations, both prior to a drug’s approval and after it is marketed.
The five risky drugs, according to Graham, are: Accutane, an acne treatment; the arthritis medicine Bextra; the cholesterol–lowering drug Crestor; the diet drug Meridia, and the asthma medicine Serevent. “A lot of drugs out there are needlessly risky,” said Larry Sasich, a researcher and pharmacist with the consumer group, Public Citizen (Baltimore Sun, November 19, 2004). The group believes over 150 approved prescription drugs are dangerous, including the five cited by Graham.
Accutane
Accutane (isotretinoin) is approved for the treatment of severe acne. The drug may have been over prescribed for more mild forms of acne, however. Accutane can cause serious birth defects, including heart and brain damage. The medication is also linked to depression in some users.
In August 2004, the Accutane label was revised to say that “Accutane must not be used by females who are pregnant” and to warn of the “extremely high risk ” that a pregnant woman who takes Accutane will give birth to a deformed baby. Earlier in the year, an FDA advisory panel recommended restrictions on Accutane and declared that a voluntary tracking system known as SMART (System to Manage Accutane Related Teratogenicity) was a failure. Despite the SMART tracking system to keep pregnant women from taking Accutane, some women became pregnant while taking the drug, according to data from both its manufacturers and Public Citizen (Press Release, February 26, 2004). Accutane has been available for fourteen years.
Bextra
Bextra is used to relieve the symptoms of osteoarthritis and rheumatoid arthritis, and to treat painful menstrual periods (dysmenorrhea). Like Vioxx, Bextra (valdecoxib) belongs to the class of drugs known as COX–2 inhibitors, and has also been associated with heart problems. Bextra increases the risk of heart attacks in patients who have undergone coronary bypass surgery. (See Bextra May Cause Heart Problems).
Bextra can also cause a severe allergic skin reaction known as Stevens–Johnson syndrome in some users. Considered a disorder of the immune system, Stevens–Johnson syndrome leads to a painful blistering of the skin and mucous membranes. The patient’s skin may slough off; eyesight may also be affected. In some cases, Stevens–Johnson syndrome can prove fatal.
The FDA first approved Bextra in November 2001. The agency may add a black box warning about Stevens–Johnson syndrome to the Bextra label. (See FDA Likely to Put Warning on Arthritis Drug Bextra).
Crestor
The FDA approved the statin, Crestor, in August, 2003 to control cholesterol levels. Crestor can cause rhabdomyolysis, a condition in which muscle cells break down and release myoglobin. Myoglobin is toxic to kidneys, resulting in kidney damage or failure. Another statin, Baycol (cerivastatin), was removed from the market because of fatal cases of rhabdomyolysis. (See Consumer Group Urges Ban on Statin Drug for more details).
Meridia
Meridia (sibutramine) increases levels of brain chemicals that help reduce appetite, according to its manufacturer, Abbott Laboratories/Knoll Pharmaceuticals. The drug may also increase blood pressure and heart rate, however, leading to serious side effects. From 1998 through 2002, Meridia likely caused 397 adverse reactions and 29 deaths nationwide, including 19 from heart complications, according to FDA data cited by Public Citizen. The group has called Meridia “unacceptably dangerous.”
When asked if Meridia’s benefits outweighed its risks, the FDA’s own Endocrinologic and Drugs Advisory Committee originally voted 5 to 4 against the drug’s approval (Endocrinologic and Metabolic Drugs Advisory Committee #64, FDA, 1996). One of the agency’s medical officers, Dr. Eric Colman, expressed great concern about Meridia’s effects on blood pressure. Nevertheless, the FDA approved the drug in November, 1997, and it is still available.
Serevent
Serevent (salmeterol xinafoate) is a medication that treats the symptoms of asthma and helps prevent bronchospasms in patients with chronic obstructive pulmonary disease (COPD). However, a safety study from 1996 through 2003 suggests that the drug may actually increase the risk of asthma episodes and asthma–related deaths. The drug maker GlaxoSmithKline sent a warning letter about Serevent to doctors in January of last year, and the FDA issued an advisory.
Our Concern for Drug Safety
At Brayton Purcell, we are concerned about hazardous drugs. If you or a loved one has suffered an injury from a prescription drug such as Accutane, Crestor, Meridia, or Serevent, please feel free to contact us to learn about your legal choices. There is no charge for our initial consultation. We have been successfully handling cases on behalf of injured consumers for over 20 years, and aggressively fight to protect the legal rights of our clients.