Articles Posted in Dangerous Drugs

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It’s reasonable to expect that the medications we use to treat conditions should be safe to consume, but all too often San Francisco personal injury attorney Gregory J. Brod has been made aware of people who are sickened or worse by the drugs they take. And now, even one of the most common class of medications that millions of Americans rely on for relief, antacid drugs, may be hazardous to one’s health.

According to the San Francisco Chronicle, a study conducted by Kaiser Permanente researchers that was released Tuesday has found that the long-term use of popular antacid drugs for indigestion relief can cause a deficiency of vitamin B-12. In its untreated form, that condition, in turn, has been blamed for an increased risk of dementia, nerve damage, anemia and other potentially serious medical issues.

The study, which was published online in the Journal of the American Medical Association, found participants who consumed a class of drugs known as proton pump inhibitors – commonly known to the public through brand names such as Prilosec, Prevacid and Nexium – for a period longer than two years ran a 68 percent greater chance of developing a vitamin B-12 deficiency.

The use of antacid drugs for the treatment of heartburn, stomach acid reflux disease and gastric ulcers has been fairly common in the United States since the 1990s, and many Americans typically take them for no more than the maximum recommended duration of eight weeks. However, some consumers have been taking antacids for much longer periods.

The vitamin B-12-linked conditions associated with long-term use of proton pump inhibitors seem to be triggered because this class of antacids does such a good job of shutting down the stomach cells responsible for producing acid – but those same cells are needed to absorb vitamin B-12.

While the revelations from the Kaiser study are new, the connection between the use of proton pump inhibitors and medical problems is an established one, including these findings from the federal Food and Drug Administration:

  • An FDA report issued in May 2010 found a link between the high dose, long-term use of proton pump inhibitors and the risk of possible fractures of the hip, wrist and spine
  • An FDA safety communication issued in March 2011 warned of the risk of low magnesium levels associated with the long-term use of proton pump inhibitors
  • An FDA safety communication issued in February 2012 warned of associated diarrhea linked to the use of proton pump inhibitors

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Americans are obsessed with all things Extra Large, from pizza to popcorn and from sodas to café mochas (with extra whip cream, of course). This, in turn, leads to another American obsession: Weight Loss. While some turn to the time-tested method of diet and exercise, others look for a shortcut that makes the process easier and faster. Sadly, many of these quick fixes involve dangerous diet pills. If you took a product looking for a weight loss solution (pill or powder, “cure” or supplement, or even just a little help in the process, and it made you ill (or if a diet pill claimed a loved one’s life), our San Francisco and Sacramento diet drug danger attorney.

Overview of the Diet Pill Debate

pills2.jpg As discussed in a recent San Francisco Chronicle piece, there is an increasing tendency to treat obesity as a medical disorder that should be treated as such. The drugs are almost always intended to be used in conjunction with diet and exercise and the majority of doctors still prefer those approaches. Two new drugs are gaining attention, notably following on the heels of “a rash of prescription weight-loss lemons” that have led the Food and Drug Administration to view the treatments with a cautionary eye. Both of these new drugs, Belviq and Qsymia, were approved last year after having been initially rejected and with the requirement that longer-term trials be performed to check on stroke and heart-related risks. One doctor said he’s wait to see results over 3 to 5 years, stating: “At this point, any benefits are outweighed by unknown risks.” However, others believe even a small weight loss can lead to major benefits and see the drugs as necessary treatments.

We’ve all heard the message that drinking and driving don’t mix. Intense education campaigns have taught people that driving while drunk threatens the safety of the driver and everyone else who has the misfortune of travelling on the same road at the same time. However, while they know about the danger of drunk driving, people often fail to identify the broader threat of “driving under the influence,” a threat that also includes driving under the influence of drugs. Drugged driving can involve legal or illegal substances. It also includes the category of synthetic drugs, a growing concern to our Sacramento DUI injury law firm.

Understanding Synthetic Drugs

Synthetic drugs, as discussed by the White House’s Office of National Drug Control Policy, are often sold in stores with labels often read “not for human consumption,” a falsehood that masks their intended use and allows the substances to avoid FDA regulation. Examples of synthetic drugs include synthetic marijuana, plant materials that are laced with chemicals that mimic THC which is the active ingredient in marijuana (also known as “Spice” or “K2”), and “bath salts,” which contain manmade chemicals akin to amphetamines. A 2011 study revealed that 11.4% of high school seniors had used synthetic marijuana in the past year, making it the second most commonly used illicit substance for the age group. Public health officials note that the adverse health effects of synthetic drugs can include hallucinations, paranoia, violent behavior, agitation, elevated blood pressure, high pulse rate, and seizures.

We take medications to protect our health and cure diseases. In doing so, we trust in our government regulation and in the manufacturers themselves to ensure that the benefits of the drugs outweigh potential adverse effects. At The Brod Law Firm, we know that medication errors and dangerous drugs are a very real problem. These cases are complex and often require significant expert analysis to determine whether a medication was unduly dangerous and the cause of a negative outcome. However, while even the victims of dangerous drugs may be uncertain of what caused their injuries, some cases of contaminated medication can be shockingly blatant. These cases leave our San Francisco product liability law firm, and the general public as a whole, stunned at how such glaring errors can occur in what should be a carefully controlled environment.

pillbottle.pngAccording to CNN, the Food and Drug Administration (“FDA”) recently advised consumers to stop taking a popular medication because the pills may be contaminated with small specks of glass. The medication at issue is a generic form of the cholesterol drug Lipitor that is manufactured by Ranbaxy Pharmaceuticals, the world’s 12th largest maker of generic drugs and India’s largest pharmaceutical company. Although Ranbaxy initiated a recall of forty-one lots of the pills nearly three weeks ago, the FDA’s announcement on Thursday November 29 is the first time the agency told consumers to stop using the medication. Additionally, the FDA announced that Ranbaxy will stop manufacturing atorvastatin while the company and the administration investigate how the glass got into the pills.

Despite the FDA pronouncement, some pharmacies have told customers that it is safe to continue taking the medication. Brian Henry, the vice president of corporate communications for Express Scripts, explained the matter is a “pharmacy-level recall,” meaning the pharmacies themselves will stop dispensing contaminated lots of the pills but users could take already purchased medication, despite confirmation from the FDA that some pills from the lots at issue may have already reached consumers. Henry added that Express Scripts will not issue refunds on the medication. CNN also spoke with several CVS-based pharmacists who advised customers it was okay to take the medication but said they would replace the pills at a patient’s request.

One of the stories dominating the headlines in recent weeks is the outbreak of fungal meningitis stemming from contaminated medications. As a San Francisco dangerous drugs law firm, we strongly believe that Americans should be able to trust the medicine they receive, whether purchased from a pharmacist, bought over the counter, or obtained directly from a provider during a medical procedure. The current outbreak is yet another reminder of the dangers involved with bad drugs.

needle.jpgOverview of the Outbreak

According to a report from CNN released early on Tuesday October 16, fifteen people had died as a result of the fungal meningitis outbreak. Authorities traced the outbreak to a contaminated steroid, methylprednisolone acetate. The drug is produced by the New England Compounding Center and the Center for Disease Control (“CDC”) recently estimated that medical offices gave the injectable product to approximately 14,000 people. The CDC reports that 214 cases of the disease have been linked to the contaminated medication, with cases spread across fifteen states. As a quick note, compounding pharmacies combine various ingredients to create a medication specifically made for a particular patient.

The recent spate of advertisements focusing on life-enhancement through medical science. While making these advancements, the companies are also working to market their new product to consumers, a process that sometimes has two steps: 1) Convincing the customer that they are facing a meaningful health issue, and 2) Convincing the customer that the product is an effective treatment for said condition. Uncertainty about both the condition and the treatment can lead to poor results when the product is ultimately used. Our San Francisco products liability team works to help the victims of dangerous drugs recover when companies market and sell unsafe medications.

pillbottle.pngAbbott Laboratories manufacturers Androgel, a testosterone gel used by millions of men worried about low testosterone (“Low T”) levels as they age. Testosterone levels decline starting around age forty and drugmakers, along with some physicians, have touted the benefits of gel for reversing some signs of aging. However, as discussed in an Associated Press article carried by the San Francisco Chronicle, there is a disturbing lack of evidence supporting the treatment. The Low T debate is only one example of the increase in attention to problems once considered a normal part of the aging process. With the aging baby boomer population and longer life expectancy, drug companies and others have targeted age-related changes with promises of longer youth. Print and television advertisements targeted testosterone treatments rose more than 170 percent in the past three years with over $14 million spent in 2011, leading to a 90 percent rise in the number of prescriptions in the last five years.

As a whole, testosterone therapy is not entirely new. Injections have long been used to treat certain medical conditions that lead to a drop in the hormone. However, the latest push markets the hormone to a wider range of otherwise healthy men. Some researchers worry that the treatments are being marketed without sufficient scientific support, including disagreement about what constitutes a normal hormone level in older men. Further, there is little understanding as to whether replacement therapy actually helps symptoms that advertisers associate with Low T. In one study on 230 men in 2008, treatment did not statistically improve muscle strength, bone density, or overall quality of life. Another study is currently underway through the National Institute on Aging, but results aren’t expected until 2014.

Puprle%20pills.jpg On June 1, 2012 the Federal Drug Administration (FDA) issued a warning to consumers against the use of the self- proclaimed dietary supplement Reumofan Plus and Reumofan Plus Premium. Reumofan Plus is manufactured in Mexico by Riger Natural. The label on its packaging is in Spanish but may be available with English labeling as well. Reumofan purports to relieve arthritis, rheumatism, and osteoporosis. It also claims to assist in preventing bone cancer. In actuality, ongoing lab tests conducted by the FDA show that the supplement potentially causes bone and muscle injuries. After receiving reports of liver injury, problems with kidney function, and irregular blood sugar levels the FDA started working with the Mexican Ministry of Health, which issued a recall of the product.

Since June 1, the FDA has received additional reports of injury related to the use of Reumofan, including severe bleeding, stroke, and even death. Consequently, it issued a second warning about Reumofan on August 21, 2012. Multiple lab tests on samples of the composition of the product found three types of prescription drugs, despite the label’s assertion that Reumofan uses 100% natural ingredients.

The prescription ingredients found in Reumofan are diclofenac sodium, methocarbamol , and dexamethasone. Each of these prescription drugs has serious risks and possible side effects. Diclofenac sodium is an anti-inflammatory that increases the risk of heart attack and stroke. It may also cause bleeding, ulceration, and fatal perforation of the stomach and intestines. Metocarbamol is a muscle relaxant that may cause sedation, dizziness, and low blood pressure, making it unsafe to operate vehicles or machinery. Dexamethasone may cause the most adverse symptoms. It can impair the immune system’s ability to fight off infection, cause high blood sugar levels, bone and muscle injuries, and even psychiatric problems. If dexamethasone is taken for long periods or at high doses, it may also cause problems with kidney function.

Furthermore, dexamethasone is a corticosteroid, and sudden discontinuation of corticosteroids after prolonged use can cause withdrawal symptoms. These symptoms include fatigue, nausea, low blood pressure, low blood sugar, fever, dizziness, and muscle and joint pain. Elizabeth Miller, Pharm.D. and acting director of the FDA’s Division of Non-Prescription Drugs and Health Fraud recommends that anyone who recently took Reumofan consult with a doctor to see whether they should taper off Reumofan to avoid withdrawal symptoms.

The undeclared drugs in Reumofan can react badly with other prescription drugs and therefore put consumers who are taking medication at even more risk.

The FDA has been working to identify other dangerous dietary supplements. In June, 2012 the Chicago Tribune reported that the FDA has inspected about 450 facilities that make dietary supplements in the last four years. The FDA found manufacturing violations in over half of those facilities. Violations range from unsanitary conditions to failing to verify all of the ingredients in a dietary supplement. The FDA sent warning letters to one in four of the inspected plants for serious violations.

The Chicago Tribune also reported this month about Shengyang Zhou who was sentenced to 87 months in prison for manufacturing and selling dietary supplements laced with pharmaceutical drugs that sickened consumers looking for bargain prices on diet drugs. He made the drugs in a plant in China and then smuggled them into the United States and sold them on internet sites like Ebay. According to the article, since 2008 the FDA has announced warnings on about 400 different dietary supplements containing undeclared pharmaceuticals.

Consumers should take heed of FDA announcements and carefully consider their current regimen of medication when thinking of introducing a supplement into their diet. Always research non-regulated products carefully and consult a doctor if there is any question.
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