Why You Should be Concerned about Nationwide Drug Shortages

In recent weeks, news stories about cancer drugs in dangerous short supply have been capturing headlines across the nation. But few people know that cancer drugs are not the only vital drugs in short supply.

Nationwide, hospitals and ambulance companies have had to ration supplies of hundreds of medications used to treat common injuries.  Some of the most commonly used drugs in short supply are:

  • Midazolam & Valium—used to treat seizures
  • Morphine & Fentanyl—used to treat pain
  • Zofran—used to treat nausea and vomiting
  • Benadryl & Epinephrine—used to treat allergic reactions
  • Mannitol—used to control pressure in patients who have head injuries

In the Dallas-Fort Worth area, paramedics who work for Medstar are using drugs past their expiration dates in some cases, because they simply do not have a stable supply of the medicines.  While the drugs can be made by local pharmacists, they typically do not last as long as those provided by the drug companies.

Attempting to address the shortage, President Obama signed an Executive Order just last year in which he directed the FDA to prevent and reduce the number of drug shortages that have been growing over the past few years. 

Pharmaceutical companies that manufacture these drugs have cut back manufacturing significantly, arguing that they make little profit on these common drugs.  But the Department of Justice has launched an investigation into whether some of these pharmaceutical companies are creating artificial shortages in order to increase demand, and therefore, increase prices.  If pharmaceutical companies have been illegally price-gouging or stockpiling medications, they could face criminal charges.

For now, the FDA is taking steps to protect consumers and prevent price gouging by instituting early notification requirements of potential drug shortages.  Unfortunately, this may be another case of big pharma putting profits before patients and consumer safety.

To learn more about the pharmaceutical industry, download my FREE ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com.

Celebrity Endorsements of Dangerous Drugs

Paula Deen recently endorsed the potentially dangerous diabetes drug Victoza, making headlines that have drawn criticism.

On Victoza's label is a warning that the drug may cause pancreatitis, much like the warnings on other diabetes drugs Byetta and Januvia. Since the drug was approved in 2010, health experts have become increasingly concerned that this drug also increases the risk of pancreatitis. 

But Paula Deen is not the only celebrity who has promoted or is currently promoting a potentially dangerous drug. Other celebrities include Paul and Mira Sorvino who have promoted diabetes drug Lantus, which studies have found may double the user’s risk of getting cancer.

And diabetes drugs are not the only pharmaceutical drugs with dangerous side effects. Within the past couple of years, studies have shown that bisphosphonates, like Boniva and Fosamax, cause low impact femur fractures. Many of the patients taking these drugs who suffered femur fractures were doing simple activities at the time of the fracture, including stepping off a curb. Actress Sally Field has appeared on commercials for Boniva since 2006. 

In addition, pro-golfer Phil Mickelson suffers from psoriatic arthritis, an autoimmune disease. He is currently endorsing Enbrel, a drug that blocks proteins, which can cause arthritic inflammation. Enbrel and other drugs like it suppress the immune system, putting patients at risk for contracting dangerous infections, including tuberculosis and histoplasmosis. Numerous deaths have been linked to these infections.

Finally, former Olympic champion Bruce Jenner promoted the top-selling arthritis drug Vioxx. But in 2004, Vioxx was recalled after studies found it increased the risk of heart attack. Jenner claimed that he had never been told about the risks.

Unfortunately, some drug companies care more about profits than about the health of patients. To learn more about the secrets of the pharmaceutical industry and deadly side effects, download my e-book, 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know.

DEA Fines Las Vegas Pharmacy in Violation of Federal Drug Laws

The Drug Enforcement Administration (DEA) and U.S. Attorney’s Office in Las Vegas have been working in unison to identify pharmacies violating federal drug laws and hold them accountable for their illegal acts.  On February 7, 2012, the work of these two units paid off when Lam’s Pharmacy of Las Vegas agreed to pay a $1 million settlement fine for violations of federal drug laws.

The DEA began investigating Lam’s Pharmacy in 2006, starting with the company’s receipt and distribution of controlled substances.  After years of investigation, the DEA took the evidence it had collected to Nevada’s U.S. Attorney Daniel Bogden, alleging that Lam’s had violated the Controlled Substances Act.

Lam’s violation of the Controlled Substances Act was a civil violation, rather than a criminal violation.  Still, Bogden stresses that “Civil settlements such as this are an extremely important component in our strategy to combat unlawful prescription drug trafficking in Nevada.”

The $1 million settlement is the largest civil settlement under the Controlled Substances Act against a pharmacy that is not a chain-operated pharmacy.  Bogden promises to continue to enforce violations of federal drug laws by physicians, pharmacies, and pharmacists both civilly and criminally.  The DEA has made clear to pharmacies that they have a corresponding duty not to participate in distributing controlled substances when no valid medical purpose exists.

Although Lam’s did not admit to any wrongdoing or liability, the company has agreed to surrender its DEA registration and pay the settlement within 14 business days. Additionally, Lam’s will be sold, but the business will continue to operate in Las Vegas under new management and a new name.

I would like to congratulate the Justice Department on successfully holding Lam’s Pharmacy accountable for its violations of federal drug laws.  I hope that both the DEA and Justice Department will continue to search out pharmacies that are contributing to the pill mill problem in this nation.

To learn more about prescription drug addition, read my article “America’s Growing Addiction” at www.vanweylaw.com.

Serious Bleeding Events Reported in Patients Taking Pradaxa

Since November 2011, at least 260 deaths worldwide have been linked to new blood thinner Pradaxa.  An estimated 1.1 million prescriptions have already been written for Pradaxa, and 371,000 patients are currently taking the drug.

Serious Bleeding Events

Pradaxa was approved by the Food & Drug Administration (FDA) in October 2010 to reduce the risk of blood clots and strokes in patients with non-valvular atrial fibrillation.  Just over a year after being approved, the FDA issued a safety communication for Pradaxa, warning consumers that patients taking the drug have reported experiencing serious bleeding events.

Symptoms of these adverse events include the following:

  • Persistent nose bleeding
  • Unusual gum bleeding
  • Vomiting or coughing up blood
  • Bruising
  • Heavier than normal menstrual bleeding
  • Red or black stool
  • Pink or brown urine
  • Severe or uncontrollable bleeding

The FDA recommends that if you or a loved one experiences any of these symptoms, you seek the help of a health care provider immediately.

Can We Trust the FDA?

Although the FDA is currently investigating claims that Pradaxa has caused serious bleeding, the agency maintains that "[a]t this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”

The FDA has made statements like this before for drugs that were later proven to indeed be very dangerous.  Patients taking Avandia, for example, reported adverse events like heart attacks.  The FDA had approved Avandia in 1999 simply because it helped diabetics to control blood sugar levels.  But after nearly 47,000 people taking Avandia suffered a heart attack, stroke, or even death, the FDA finally restricted the use of the drug in 2010.

More recently, the FDA has received criticism for allowing experts with conflicts of interest to sit on a panel to determine whether the popular birth control pills Yaz and Yasmin should be taken off the market.  At least four of the experts on the panel had received compensation from Yaz and Yasmin’s manufacturer Bayer.  All of them voted in favor of keeping the pills on the market.

And it seems as though the FDA may be behind the curve on Pradaxa. Both Japan and Australia have issued safety warnings, linking Pradaxa to serous bleeding events.

To learn more about the pharmaceutical industry and why the FDA approves these dangerous drugs, download my FREE e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com today.