Drugs with Major Flaws: Prescriptions That Make You Think Twice
Before a new drug may be sold in the United States, the Food and Drug Administration (FDA) requires pharmaceutical manufacturers to conduct clinical studies demonstrating the safety and effectiveness of the drug. The FDA’s Center for Drug Evaluation and Research monitors the studies, reviews the results, approves the drug for sale if the benefits outweigh the risks, and monitors its effects in the broader marketplace. The process can take years and is designed to thoroughly determine a new drug’s contraindications and potential risks.
Most drugs that make it through the approval process are relatively safe for most users, with only a small incidence of minor side effects. The potential for a severe side effect in limited situations will not prevent approval; many relatively benign drugs can be deadly if grossly misused. However, some drugs present severe side effects out of proporition to the benefits that they provide. A few of these drugs include thalidomide, cisapride, rofecoxib and dabigatran.
Thalidomide was a drug developed in Germany and marketed widely during the mid-to-late 1950s. It was used to treat a variety of aliments, including anxiety, nausea, coughs, insomnia, and morning sickness. One group of people who commonly experienced such symptoms included pregnant women; as a result, it was widely prescribed and consumed by that particular market. By eliminating these minor symptoms, it temporarily increased the mother’s quality of life.
Not long after the drug’s introduction, pregnant mothers who took the drug began giving birth to children with severe birth defects. The drug inhibited the growth of new blood vessels in fetuses and inactivated a protein that is important to limb formation, resulting in high mortality rates accompanying phocomelia in over 10,000 children throughout 46 countries. Its effects became known quickly and the drug was banned in most countries only a few years after its introduction.
Thalidomide’s tendencies to inhibit angiogenesis resulted in the discovery of other potential uses for the drug. Initially, the drug was not approved for wide distribution in the United States by the FDA. It and some of its derivatives were approved later to treat multiple myeloma and leprosy. Its present applications and distribution are regulated to ensure that the drug has no contact with pregnant women.
Cisapride is a medication prescribed to treat gastroesophageal reflux disease, commonly known as acid reflux disease. Acid reflux disease occurs when the lower esophageal sphincter between the esophagus and the stomach fails. Its failure can result in stomach acid and bile from entering the esophagus, causing pain, nausea, and a condition known as Barrett’s esophagus. The disease is common and is not fatal by itself.
Like most common heartburn medication, Cisapride is ingested orally no more than four times per day. It was also widely used; in 1996, Cisapride’s brand name Propulsid was prescribed to over 5.4 million people in the United States alone. In 2000, it was voluntarily removed from the U.S. market as a result of its side effects, although it is still available for veterinary use. Its use in other countries was highly restricted for the same reasons.
The drug’s most dangerous side effect was its tendency to inhibit the Human Either-a-go-go Related Gene (HERG). The HERG is responsible for coding the Kv11.1 protein in potassium ion channels. These channels coordinate the human heartbeat. Inhibiting the HERG can result in long QT syndrome, a potentially fatal disorder that stems from a prolonged QT interval. The QT interval is the time lapse between the Q wave and T wave in the heart. A prolonged QT interval can result in fainting and even sudden cardiac death. Such cardiac events resulted in its withdrawal from the market.
Rofecoxib (Vioxx, Ceoxx, Ceeoxx)
Rofecoxib is a pain reliever approved by the FDA in 1999 and voluntarily withdrawn from the market by Merck & Co., Inc. in 2004. It belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs inhibit the production of prostaglandins, or common lipids that are produced at the site of inflammation. Prostaglandins have numerous valid functions and targeting all of them is undesirable. Instead, rofecoxib selectively inhibited cyclooxygenase-2 (COX-2), an enzyme believed to mediate the production of prostaglandins that were responsible for this pain.
Unfortunately, COX-2 also produces prostacyclin, a natural vasodilator. Vasodilators expand the blood vessels, which decreases vascular resistance. This lowers blood pressure and provides a valuable defense to the body in the event of cardiac arrest or other negative cardiovascular events. By inhibiting COX-2’s ability to produce prostacylin, the drug presented a number of risks to patients at risk of cardiac events.
The drug was voluntarily withdrawn as a result of internal findings. In 2001, Merck initiated a three year trial to assess the cardiovascular safety of the drug. While the first 18 months of rofecoxib presented to cardiovascular issues, pronged usage resulted in a heightened risk of a heart attack or stroke. The risk of heart attack or stroke rose further with increased dosage. The drug was used by over 80 million people and was associated with 88,000 to 140,000 cases of heart disease.
Despite posing similar risks, other COX-2 inhibitors remained on the market after Vioxx was publicly withdrawn. Celecoxib is still available under the brand name Celebrex as a pain reliever. The effect of other NSAIDs remains unclear to date, as many NSAIDs inhibit COX-2 to one extent or another including ibuprofen and naproxen, which are relatively benign at low dosage levels.
Dabigatran is an anticoagulant developed by German pharmaceutical manufacturer Boehringer Ingelheim and approved by the FDA in 2010. It is marketed under the name Pradaxa in the United States, Europe, Australia, and Canada. It is primarily used as an alternative to warfarin to reduce the incidence of stroke in patients with atrial fibrillation or patients who have recently undergone a hip or knee replacement surgery. It inhibits the enzyme thrombin, reducing clotting and thinning the blood.
Dabigatran helps prevent thrombosis in such patients, improving blood flow. However, clotting is a biological process necessary to stop bleeding. Anticoagulants like Pradaxa present risks of increased bleeding, which is exacerbated by age and the concomitant use of common medication like NSAIDs and aspirin.
Gastrointestinal bleeding is one of the most common serious adverse effects of taking Pradaxa. In 2011, Pradaxa was prescribed to 2.2 million patients; in that same year, it was associated with 3,781 adverse events including 542 deaths. In that same year, warfarin was responsible for only 1,106 serious adverse effects despite the fact that warfarin is prescribed to over 33 million patients in the United States. Visit www.pradaxalitigation.com for more information on the drug and the lawsuit that is currently pending.
Bringing a new drug to market will always result in some people experiencing some side effects. Some of these effects are more serious than others. When the drawbacks of a drug begin to outweigh the benefits, consumers should avoid it. Victims who suffer these severe side effects may wish to seek out an experienced tort lawyer. Alleviating a headache or ridding one’s self of heartburn should not be a life-threatening activity.
Researcher Melanie Fleury has a father that takes more than a dozen pills a day for various ailments. She can only imagine the devastation should one of these life saving medications actually threaten his livelihood. This article is written as an effort to educate those who may be taking a potentially dangerous prescription. The website of www.pradaxalitigation.com offered her valuable information on various health and legal issues associated with the drug.
Photo Credit: http://www.flickr.com/photos/erix/142789779/
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