Category: Pennsylvania pharmaceutical injury

FDA Questions Safety of Inhalable Caffeine

dangers of inhalable caffeine

Ever have one of those days where you just wish you could inject caffeine into your system and be on your way? Well, while you can’t get a direct shot to your blood apparently you can just breathe in the caffeine without the damaging effects of drinking energy drinks, shots, or pills. AeroShot is a revolutionary product that dispenses caffeine and B vitamins into your mouth without any calories.

While this may seem like a blessing in disguise, the Food and Drug Administration (FDA) is not so sure. According to a CNN report, the Administration is planning on investigating this new form of caffeine intake because they question its safety. The report explains that consumers can currently purchase the AeroShot, a lipstick-shaped container that dispenses the caffeine and vitamins, online or at convenience stores in both New York and Boston. And the kicker of it all—it only costs $3.

A single tube of AeroShot can be consumed all at once or in small doses according to the product’s website. In the CNN report one New York Senator, Charles Schumer, is very wary of the consequences of a product like this.

He told CNN that, “This product could be very dangerous. There might be legitimate uses. The business man staying up late who doesn’t want to drink that cup of coffee, that’s OK. But what about kids who go to bars and take several shots of AeroShot so they can drink more?”

The Senator brings up a valid point. There has been a lot of attention in the media of the dangerous of mixing caffeine and alcohol—remember the Four Loko scandal? Even with caffeine / alcohol combination drinks being altered to be less dangerous people are still dying.

Just this past weekend there was a 13-year-old boy from Maryland who died after consuming Four Loko according to news reports. So what is going to stop individuals from abusing the ease of this caffeine intake? After all, it won’t be like pounding down a Red Bull which could make you full and unable to drink as much. Senator Schumer took his concerns to the FDA by writing them a letter and the FDA reported that they will investigate his concerns and send him a response directly.

Although it is an energy supplement, in the FDA’s eyes energy pills, shots, etc. fall under the same regulations as dietary supplements. CNN reported that:

The company making them is responsible “for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading,” according to the FDA website.

It’s rare for the agency to prohibit a supplement. In 2004, it stopped the sale of the diet supplement Ephedra, but only after deaths and other serious side effects were reported.

“Manufactures are free, basically, to sell almost any product they want and to make any claims they want about dietary supplements” [David Schardt, from the Center for Science in the Public Interest] said. “It’s the burden of the Food and Drug Administration to prove that a product is unsafe and the dietary supplement industry has lawyers to defend their products and it’s a long involved process.”

At this point it is just a game of wait and see. The product has not been removed from the market, but depending on what the FDA concludes in its investigation inhalable caffeine may become just another failed product.

The FDA plays a very important role and in conjunction with other government agencies helps protect consumers from hazardous or harmful products. If you or someone you love has been injures as the result of a dangerous or defective product of any kind you may be entitled to compensation. Contact the Philly accident lawyers at Console & Hollawell today to find out what your legal rights and options are. Call us today at (866) 778-5500 to set up your free consultation.

All photos from AeroShot website.

6 Notorious Drug Recalls of the 2000s

drug recalls

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.

Photo credit: Current Class Action.

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

Photo credit: Ivstatic.

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.

Photo credit: Just How.

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.

Photo credit: Life.

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.

Photo credit: Ivstatic.

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.

Photo credit: Ivstatic.

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.

If you or someone you love has been injured or has died because of the consumption of a dangerous medication you deserve compensation. The Pennsylvania pharmaceutical injury lawyers at Console & Hollawell have the knowledge and experience needed to protect your rights and recover the damages you deserve. Call us today at (866) 778-5500 to set up your free, no-obligation consultation.