Jacksonville Personal Injury Blog

The consumer advocacy group, Public Citizen, has called on the U.S. Food and Drug Administration (FDA) to withdraw a diabetes drug because of concerns of heightened pancreatitis, kidney failure, and thyroid cancer risks.

Public Citizen says that in a crowded field of similar diabetes drugs, the drug Victoza, which is manufactured by the Danish pharmaceutical manufacturer Novo Nordisk, has risks that far outweigh its benefits.

To back up its claim, the advocacy group cited that reports of pancreatitis were 3.7-times higher in patients who had used Victoza as opposed to other similar diabetes drugs. Public Citizen also claims that medical reviewers for the FDA noted that the drug had caused thyroid tumors in rats and mice. Because lab outcomes with rodents cannot conclusively prove reciprocal outcomes in humans, the FDA warning label for the drug currently states it is “unknown whether Victoza will cause” thyroid cancer in humans.

According to the Huffington Post, Novo Nordisk denies the allegations, claiming that it has worked closely with the FDA and that the agency approved the drug based on studies involving over 4,000 patients.

Public Citizen cited internal FDA documents in which three of the medical reviewers were against the 2010 approval of the drug. One of the reviewers wrote, “The need for new therapies for Type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”

A Florida dangerous product injury lawyer at Farah & Farah will be keeping tabs on the risks associated with Victoza and other potentially harmful drugs on the market. If you believe you have been injured due to an adverse drug reaction, you might be eligible for compensation. Call us at (800) 533-3555 for a free and confidential assessment of your case.

The U.S. Food and Drug Administration (FDA) is investigating how fake vials of the widely used cancer drug Avastin found their way to 19 doctors and clinics in the United States — raising alarms that the large, and growing, multi-billion worldwide drug-counterfeiting trade is making further inroads into America.

Reuters reported that the trail of the fake Avastin led back to an Egyptian company called SAWA. Hadicon, the Swiss-based import/export company that purchased the fake drug from SAWA, provided an address for the company that was located in Giza, a suburb of Cairo. However, reporters who went to the location revealed that no such company existed and locals had never heard of it. Egyptian authorities say the company is not registered with the Egyptian Health Ministry either.

Hadicon, which claims it was unaware that it was exporting a phony drug, sold to a British company, which in turn exported it to a Tennessee-based wholesaler called Volunteer Distribution.

This latest bogus drug scare, along with past incidents of counterfeited Viagra, Lipitor, and Alli that have hit the U.S. market, highlights the growing complexity and dangers of the worldwide drug supply-chain. Drugs and drug ingredients sold in the U.S. are increasingly being manufactured overseas in countries with spotty regulations and poor oversight.

Last year 1,700 cases of drug counterfeiting were reported worldwide. The U.S. accounted for six percent of those cases.

Fake Drug Dangers

With more drugs and drug ingredients being imported from overseas, it is becoming clear that stricter oversight of imported drugs and drug ingredients is sorely needed. Fake drugs are not only illegal, but also potentially deadly. If any drug has harmed you, you have legal recourse to obtain compensation for your injuries. Call the Florida dangerous drugs lawyers at Farah & Farah for a free and private consultation. We’re available day or night at (800) 533-3555.

Sources http://www.reuters.com/article/2012/02/21/avastin-egypt-idUSL5E8DL8R020120221;http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm?utm_source=fda&utm_medium=website&utm_term=Aspirin&utm_content=f1&utm_campaign=HomePageSpotlight

They are considered a win-win for the pharmaceutical industry. A big name drug company wants to keep making enormous profits on its brand-name drug, but the patent is expiring and the generic version is eager to get into the market. The solution that seems to be working for everyone is that the big-name manufacturer pays to delay the generic’s entry into the market. It’s cheaper in the long run than losing revenue to the competing generic, and the generic likes it because it can receive payments essentially for NOT making a drug.

This pay-for-delay is a win-win for everyone except the consumer. Public Citizen’s Health Research Group reports that the consumer loses because they miss out on the lower generic price that can cost as much as 90 percent less than the high-priced brand-name. For a $300 a month drug, for example, the consumer could pay as little as $30 a month (or thousands less every year). For example, when the patent for the narcolepsy drug Provigil was expiring, drug maker Cephalon paid about $200 million to generic companies to drop their competition. The company made $4 billion.

Some of these payments to generic makers can last nearly 17 months, the citizen group reports. And Public Citizen compiled data from the U.S. Federal Trade Commission (FTC) that shows for six fiscal years beginning in 2004, there were 66 of these delay agreements. And it appears to be getting worse. Public Citizen reports in just the last two years, there were 59 of these agreements.

The projected ten-year cost to Americans is $35 billion.

The obvious solution from a pro-consumer perspective is to stop these deals and lower the price of drugs. Legislation is pending, but your representatives in Congress need to hear that this is an important issue to you. The legislation is Senate Bill 27, the Preserve Access to Affordable Generics Act.

Farah & Farah encourages you to call your representative to let them know you care about the price of drugs and want cheaper alternatives.

Whether it resulted from a generic or brand name drug, any patient who has had an adverse experience with a medical drug they are using can call the Florida dangerous drug lawyers of Farah & Farah. If the manufacturer was negligent and failed to warn the public about the dangers of their drug, they can be held legally accountable. Call (800) 670-1464 for a free consultation.

Source: Worst Pills (by subscription) http://www.worstpills.org/; http://pubcit.typepad.com/clpblog/2011/05/more-on-pay-for-delay-drug-patent-settlements.html; http://www.votesmart.org/public-statement/646912/dealmaking-in-pay-for-delay-settlements-continues-between-brand-name-and-generic-prescription-drug-makers