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Posted On December 28, 2011 Drug Risks,Product Recalls

6 Notorious Drug Recalls of the 2000s

Drug recalls are scary. It can be hard to understand how a drug was approved by the Food and Drug Administration and then later be found to be dangerous, but over time some medications show their true dangers that were not originally seen or anticipated. All recalls are reported on the FDA website, and everyone should stay diligent with checking for health alerts and recalls. Each year about 106,000 deaths are caused by prescription drugs each year.

When pharmaceuticals are found to be defective, dangerous, or contaminated they could cause harms more serious than the ailment they were meant to treat. There are many recalls issued each year, but these notorious drug recalls are ones that will go down in infamy.

1. Darvon, Darvocet (Propoxyphene)

Manufacturer: Xanodyne Pharmaceuticals Inc. (Darvocet), Eli Lilly and Company (Darvon), and others
Recalled: November 2010

Propoxyphene is an opioid that was used to treat mild to moderate pain, which was taken off the market in November 2010. Xanodyne Pharmaceuticals, which manufactured the brand version of the medication, decided to voluntarily remove the medication from the market after it was learned that the medication caused serious and fatal heart rhythm abnormalities. The FDA also informed companies that produced generic medications containing propoxyphene of the risks and asked that they too remove their products from the market after Xanodyne’s decision. The drug was banned in the UK and Europe before it was in the United States.

This video helps explain the dangers of this drug and information about its ban: FDA Pulls Popular Painkiller off Market

2. Vioxx

Manufacturer: Merck & Company Inc.
Recalled: September 2004.

Vioxx was an arthritis and acute pain medication. It was recalled in 2004 because serious concerns arose during a clinical trial where they were testing its effectiveness for helping with colon polyps. It was discovered that this medication significantly raised the risk of heart attack and stroke. The drug was linked to 27,000 heart attacks and cardiac-related deaths. The BBC reported that as of November 2007, the company had already paid out $4,850,000,000 to settle lawsuits brought up because of Vioxx.

3. Bextra

Manufacturer: G.D. Searle & Company, now part of Pfizer
Recalled: 2005.

Very similar to Vioxx, Bextra was used as an anti-inflammatory and painkiller. It was removed for the same reason as Vioxx, a link to increased risk of heart-attack and stroke. The infamy surrounding this recall came about when it unveiled a larger problem—the drug was being promoted for uses it was not approved for. The New York Times reported that the company settled with 33 states who were investigating Pfizer for $60,000,000.The NYT also reported that in 2008, Pfizer set aside $894,000,000 in order to settle the many personal injury lawsuits brought up against the company.

4. Lipobay, Baycol

Manufacturer: Bayer
Recalled: August 2001.

Lipobay (also known as Baycol and Cerivastatin) was a medication that treated high cholesterol. It was recalled because it was linked with a severe muscle disorder known as rhabdomoyolysis. This disorder causes the kidneys to clog with protein from dying muscle tissue, which can cause kidney failure and death. The New York Times reported in 2003 that the medication was linked to more than 100 deaths. The article also explained that the recall and lawsuits over Baycol had cost them $150,000,000—and that was when there were still more than 8,000 lawsuits pending against Bayer.

5. Able Laboratories generic prescription drugs

Recalled: May 2005.

Able Laboratories was a company that manufactured generic prescription drugs. In 2005 the FDA notified consumers and healthcare professionals that there was a nationwide recall issued. There were serious apprehensions about the drugs not being produced according to quality assurance standards. The drugs were found to either be too potent or not potent enough. The massive recall seriously impacted Able Laboratories and was the reason for their suspension of production.

6. Tylenol

Manufacturer: McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson
Recalled: January 2010, April 2010, June 2010, October 2010.

Many have a hard time forgetting the notorious Tylenol contaminations in the 80s, but various forms of Tylenol have been recalled in recent years. The April 2010 recall was issued when fears of a Burkholderia cepacia (B. cepacia) contamination arose. This recall affected Children’s and Infant’s Liquid products. B. cepacia is known to be resistant to antibiotics; the bacteria was really only a threat to those with weakened immune systems. The January 2010 recall was issued when various Tylenol products were found to have trace amounts of a chemical that is applied to wood pallets. They smelt moldy and caused various gastrointestinal problems—though they reported none were severe. The June 2010 recall was an expansion of the January recall adding several more products that had been contaminated. Then in October 2010 they had to issue another recall because of a moldy and musty smell caused by a chemical, 2, 4, 6-tribromoanisole.

While this is not a comprehensive list of the drug recalls issued in the 2000s, they are some of the largest. In the end, medications should help you, not harm you, and if you are injured by a dangerous or defective pharmaceutical you should contact a skilled attorney.