Drug Injury Attorney Blog

The U.S. Food and Drug Administration has ordered makers of a drug for digestive problems to add the strongest warning possible to its label, WebMD reported earlier this year. The “black box” warning will caution patients about the risk of developing a serious and potentially incurable muscle disorder called tardive dyskinesia after taking Reglan (metoclopramide). Patients with tardive dyskinesia have involuntary, repetitive muscle spasms, including pursing and smacking of the lips, grimacing, sticking out the tongue and rapid blinking. Patients taking Reglan who have noticed these effects are encouraged to contact the FDA to report any problems with the medication.

According to the FDA press release, two million Americans take some form of Reglan. It is used primarily to treat nausea and vomiting due to certain kinds of cancer treatments, infection, drug side effects and pregnancy, as well as for diabetics with digestion problems. Tardive dyskinesia is a known side effect of Reglan, which is why the FDA recommends that patients use the drug for no more than three months at a time. However, the agency ordered the more stringent warning after recent analyses found that Reglan is the most common cause of drug-induced movement disorders. The agency had also received continuing and spontaneous reports of patients developing tardive dyskinesia after using Reglan. Reglan was also the subject of a defective drug lawsuit in California, in which drug maker Wyeth was held liable for its failure to warn patients about the risk of tardive dyskinesia.

Tardive dyskinesia is a side effect of prolonged or high-dose use of dopamine antagonist medications, including antipsychotics and neurological drugs as well as Reglan and other gastrointestinal drugs. The condition may be mistaken for Parkinson’s disease, but while Parkinson’s patients have trouble moving, tardive dyskinesia patients have trouble not moving. These patients experience involuntary, rapid and repetitive movements, especially movement in the face, fingers and extremities. The movements may or may not disappear after the drug is stopped, and they may take years to subside. There is no known cure for tardive dyskinesia, which is why medical professionals focus on preventing it by limiting the use and dosage of the drugs that cause it.

As a dangerous drug injury attorney, I noticed that Reglan is part of a class of drugs normally used to manipulate the brain chemistry of patients with menal illness or neurological disorders. That’s one reason why Reglan’s side effects include tardive dyskinesia and other neurological symptoms, from drowsiness and dizziness to neuroleptic malignant syndrome. This is too high a price to pay for relief from nausea and vomiting. As the FDA said, this black box warning on Reglan should help patients and doctors make an informed decision about whether the risks are worth the benefits. But for the millions who have already taken Reglan, it may be too late. If an investigation shows that Wyeth and others failed to adequately warn patients of the risk of tardive dyskinesia before the labeling change, patients who develop this terrible, incurable disability have the right to sue the drug makers.

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As a St. Louis drug liability lawyer, I was scandalized but not surprised by a recent revelation that Merck & Co. and Schering-Plough Corp. actively suppressed evidence about their drugs’ efficacy in order to prtect their bottom lines. The two New Jersey companies last week stated they would pay $5.4 million to settle civil claims that they had buried test results suggesting two of their new cholesterol drugs were less of a breakthrough than they were purported to be. The 5.4 million sum only represents only the costs of the investigations, which came from 35 states plus the District of Columbia. The two companies need not make any other payments, or admit to any sort of wrongdoing -- despite some pretty damning evidence.

In January of 2008, Merck and Schering-Plough released studies showing that Vytorin and Zetia were no more effective at reducing plaque buildup in neck blood vessels than Zocor, an older drug that is now available in a vastly cheaper generic form. The trouble is, these studies were completed in 2006 -- two years prior to the results' release. In other words, plenty of time was allowed for consumers and their doctors to be misled into spending more money than they really needed to. With sales of Vytorin at $2.78 billion and Zetia at $2.41 billion in 2007, that means thousands or even millions of people were misled by these companies’ failure to warn them. They may also have assumed unnecessary risks of serious side effects, including muscle disease and even cancer.

In fact, a 2007 piece in the New York Times suggested that Merck and Schering-Plough may have also suppressed evidence from clinical trials that found a connection between the drugs and liver problems. But even if there were no evidence of safety problems, it’s disturbing that drug companies would choose to bury negative information about their products in order to protect their profits. If they are willing to hide information about comparative efficacy and liver disease, what else might they be hiding? This deception alone is enough to form the basis of a strong St. Louis defective medication lawsuit claiming damages for the drug companies’ failure to warn consumers.

Continue reading " Merck and Schering-Plough Pay $5.4 Million to Settle Drug Cover-Up Suits " »

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The U.S. Food and Drug Administration has required the strongest warning label a drug can have for two painkillers, the Washington Post reported July 8. Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) got the increased warning, the agency said, to reduce the risk of fatal overdoses. The new label will warn patients about the risk of an overdose, and accompanying packaging will include a medication guide emphasizing the risks of not using the drug as directed. In addition, the FDA has ordered a new study of the effects of a propoxyphene overdose on the heart.

The agency’s action came a few weeks after the European Union’s drug regulator voted to phase out Darvon and Darvocet for safety reasons. In the U.S., the activist group Public Citizen petitioned in 2006 to take propoxyphene off the market, saying it is a relatively weak painkiller with too many side effects. In fact, an advisory panel for the FDA voted in 14 to 12 January that the drug should be withdrawn from the U.S. marketplace. The FDA decided not to follow its panel’s advice (which it is free to do) saying the benefits of the drugs outweighed the risks.

According to the Post, the problem with propoxyphene is its effect on the heart. Propoxyphene can decrease the patient’s heart rate and raises the risk of a potentially fatal heart arrhythmia, which has led to fatal overdoses. Because it is also a weak opioid painkiller with potential for addiction, watchdogs may be concerned about its potential for overdoses among drug abusers. The FDA has recorded 91 cases of fatal overdose since 1969, but overdoses are widely thought to be underreported. In the form of Darvocet, which combines propoxyphene with acetaminophen, overdose also carries the risk of fatal liver poisoning.

Darvon has been on the U.S. market since 1957 -- and that’s what concerns me, as a dangerous prescription drug attorney. Though it’s not nearly as popular as prescription painkillers like Vicodin, propoxyphene is prescribed about 22 million times a year. Even if only a tiny fraction of patients overdose each year, that’s a huge number of people over the decades who may have been killed by a drug they trusted to help them. That means the pharmaceutical companies that make and sell Darvon and Darvocet could face thousands of pharmaceutical injury lawsuits from the families of people who were wrongfully killed.

Continue reading " FDA Adds Black Box Warning to Painkillers Darvon and Darvocet Because of Risk of Fatal Overdose " »

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The U.S. Food and Drug Administration announced July 1 that it would require the strongest safety warning possible on the labels of prescription smoking cessation drugs Chantix (varenicline) and Zyban (bupropion, also sold as Wellbutrin), the Washington Post’s The Checkup blog said July 1. Both are sold to people who are trying to quit smoking, but have come under fire as users and scientists began to discover serious psychiatric side effects. The black box warning will tell patients that the drugs carry an increased risk of depression, hostility, mood changes and suicidal thoughts. Manufacturers Pfizer (Chantix) and GlaxoSmithKline (Zyban) are also required to run new clinical trials examining how often these mental health problems occur in users.

The move came after multiple reports of depression, increased depression and other behavioral changes that started shortly after taking the drug and stopped shortly after discontinuing use. An FDA newsletter said it received 153 reports of suicidal “adverse events” for Chantix and 75 for Zyban since their approval for use as anti-smoking drugs. This was true at the recommended dose, for people both with and without a previous history of depression. However, the FDA noted that some of these side effects may also be associated with nicotine withdrawal. It also told users not to stop the drugs cold turkey, since this can cause side effects and smoking is a serious health risk -- just to be aware of the risk and talk to their doctors about problems.

I’m sorry to say that this is not the first report of mental health side effects I’ve seen as a dangerous drug attorney. Chantix in particular (called Champix overseas) has been under investigation since 2007, shortly after its fast-tracked approval the year before. In addition to depression and suicidal thoughts, Chantix users have reported agitation, aggression, homicidal thoughts, bizarre dreams and psychosis. Zyban users have reported similar problems, including hallucinations -- and when it is sold as Wellbutrin, bupropion already carries a black box warning about suicide.

The FDA’s action doesn’t take these drugs off the market, but the black box requirement is a powerful warning to consumers that they should be use caution. As a defective drug lawyer, I have seen several accounts of people who suffered serious psychiatric changes after starting one of these quit-smoking drugs, most recently a Pennsylvania man who said taking Chantix might have something to do with his attack on his wife. Like all manufacturers, drug makers have a legal responsibility to offer us products that are safe and free of defects. When they fail, consumers who are hurt can hold them legally and financially responsible for the results. If it becomes clear that Pfizer and GlaxoSmithKline were selling drugs without a clearly necessary warning -- or even knew of the side effects ahead of time -- they could be hit with multiple pharmaceutical injury lawsuits.

Continue reading " Anti-Smoking Drugs Chantix and Zyban Get Black Box Warning About Risk of Suicide and Mental Illness " »

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Posted In: Dangerous Drugs

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