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FDA proposes rule changes to hold generic drug manufacturers accountable for injuries
The FDA has proposed new rules that would improve generic drug manufacturer accountability. More than 80 percent of prescriptions are for generic drugs. However, a gap in the law prevents those injured by a generic prescription drug from holding the manufacturers accountable in court. The proposed change would close this loophole.
Under the current rules, generic drug safety warnings must mirror their name brand counterparts. Last year, the Supreme Court ruled that generic drug makers cannot be held liable for injuries caused by their drugs because they have no control over their labels.
The Today Show investigated drug makers’ accountability in a special report last Friday. Reporter Jeff Rossen tells the story of Viola Purcell who contracted a neurological illness from taking a generic drug. The current FDA rules prevented her from holding the generic manufacturer accountable.
Watch her story below or read it here.
The new rules are open for comment for the next 60 days.
You can help people like Viola by signing the Take Justice Back petition that
urges the FDA to act quickly to restore justice for everyone who takes generic
The petition is online here: https://www.change.org/petitions/keep-our-medicine-cabinets-safe
USPLabs, the manufacturer of the diet supplement called OxyELITE Pro, has halted distribution of the drug nationwide following multiple cases of liver failure linked to the supplement discovered by the Hawaii Department of Health. The Hawaii Department of Health requested a voluntary removal of the supplement from store shelves across the state of Hawaii. It also asked the public to stop any use of the diet supplement.
Dietary supplements have been directly linked to 29 cases of liver failure and acute hepatitis in Hawaii within the past six months. Of those 29 cases, at least 24 were among patients who reported taking the OxyELITE supplement. One case has resulted in death.
Even though OxyELITE Pro had been sold all over the United States, all of the known hospitalizations and deaths from the supplement have taken place in Hawaii. It is possible that a bad batch was sold in Hawaii. Another reason could be exposure to heat, which has been known to alter pills’ effects.
“No other supplement or medication has been identified in common among more than two patients,” said Dr. Sarah Park, Hawaii’s state epidemiologist, in a Huffington Post article.
The request by the Hawaii Department of Health to remove OxyELITE Pro from all store shelves in Hawaii resulted in almost unanimous compliance among retailers across the state. One store, however, said no.
“GNC uniformly informed us there were not going to remove it,” said Gary Gill, Hawaii Deputy Director of Environmental Health, in another news article.
The U.S. Food and Drug Administration issued a ban earlier this year against supplements containing dimethylamylamine (DMAA). This includes OxyELITE Pro. However, USPLabs has reported that the original version of OxyELITE Pro containing DMAA has not been manufactured and distributed since early 2013.
An investigation into the product by the Hawaii State Department of Health is ongoing. The department is working with the FDA and Centers for Disease Control and Prevention. If the results of the investigation prove that the supplement is a health risk because of its formula or as a result of an contamination, the Department of Health will “seize and destroy” the supplement.Comments (1)
Recently, the Food and Drug Administration (FDA) announced that the commonly used anti-malaria drug, called mefloquine hydrochloride (brand name Lariam) must have a “black box” warning on its label. The drug has been linked to serious neurological and psychiatric side effects with the potential to cause permanent damage.
A black box warning is the sternest warning from the FDA that a drug can have while remaining on the pharmaceutical market. The FDA can require a black box warning if the medication can cause serious, harmful side effects (such as life-threatening or permanently damaging reactions) in comparison to the potential benefits of using the drug, or if a serious, potentially life-threatening reaction can be prevented, reduced in frequency or reduced in severity with the proper use of the drug.
Mild to serious side effects associated with mefloquine include:
- Ringing in the ears
- Loss of balance
- Psychiatric symptoms
The drug was first used in the U.S. Army and in 1989 it entered the commercial market. The manufacturer of Lariam, Roche, no longer sells it in the United States. However, generic versions are still available.
Mefloquine was previously favored among travelers because of its effectiveness in protecting against malaria and because it only needed to be taken once per week instead of once per day. Warnings on its label have steadily increased over the last decade.
According to the New York Times, mefloquine is the third-most-prescribed anti-malaria medication in the United States. Approximately 119,000 prescriptions have been written for the drug between January and June of this year.
The most common anti-malaria drug, hydroxychloroquine, was prescribed approximately 2.4 million times during that same time period.
Read the full story about Lariam and its strengthened warning now.Comments (0)
Calcium-channel blockers (CCBs) may be associated with a higher risk of breast cancer, according to a new study. Published in the journal JAMA Internal Medicine, the study looked at the effects of the long-term use of CCBs.
What are Calcium-Channel Blockers? (CCBs)CCBs lower blood pressure by preventing calcium from entering the cells of the heart and blood vessel walls. As a result, they affect the muscle cells in the arterial walls by relaxing and widening them. Some CCBs may also slow heart rate, relieve chest pain (angina) and help control a heart arrhythmia. Common calcium-channel blockers include amlodipine (Norvasc), diltiazem (Cardizem LA, Tiazac), felodipine, isradipine (DynaCirc CR), nicardipine (Cardene SR), nifedipine (Procardia, Procardia XL, Adalat CC), nisoldipine (Sular), and verapamil (Calan, Verelan, Covera-HS).
Swiss pharmaceutical giant Roche has stopped further development of its new diabetes drug called aleglitazar. This decision could increase safety concerns for drugs similar to aleglitazar, including the controversial medication called Avandia.
Pharmaceutical company Pfizer’s lucrative cholesterol drug Lipitor is expected to generate approximately $3 billion in revenue by 2015, according to a recent report by AARP’s Public Policy Institute. The cholesterol medication is already the world’s biggest selling drug, peaking at annual sales of more than $9 billion. Lipitor has a lifetime sales of more than $131 billion.
- Increasing the price of the drug while it was still under patent.
- Advertising directly to consumers during patent years to boost usage.
- Entering into a so-called pay-to-delay deal with Ranbaxy (a producer of generics). This pushed back the initial generic introduction from June 2011 to December 2011.
- Launching a so-called authorized generic through Watson Pharmaceuticals. This shared approximately 70 percent of its Lipitor-related profits with Pfizer and decreased other generic sales.
- Providing coupons to consumers to reduce co-pays and to encourage customers to keep using the branded Lipitor and not switch to the generic versions. Pfizer also paid rebates to insurers and/or pharmacy benefit managers who kept using Lipitor.
The results of the above marketing and distribution plans helped branded Lipitor retain one-third of the market share even after the generic version was released. This goes to show that the marketing materials that consumers encounter can drown out safety considerations those consumers need to know. Just because a drug comes with a rebate or is heavily advertised doesn’t mean the drug is right for each individual consumer. Consumers should talk to their doctors about the safety risks of every drug they take because the drug could have risks that aren’t mentioned in the advertisements.
A Johnson & Johnson drug that treats type 2 diabetes in a new way is now approved by the U.S. Food and Drug Administration (FDA). Invokana, as the drug is known, will work by excreting blood sugar in the patient’s urine rather than affecting the supply or use of insulin.
This new type 2 diabetes drug falls in a class of medications called SGLT2 inhibitors. The drugs work by blocking action of the sodium-glucose co-transporter 2, which takes sugar removed from the blood by the kidneys and puts it back into the blood.
Prior to its approval, clinical trials with more than 10,000 patients revealed that Invokana improved blood sugar levels and led to lower blood pressure and weight loss. Among the estimated 26 million Americans with type 2 diabetes, many are prescribed medications that lead to weight gain and hypoglycemia, two dangerous health risks.
Clinical trials of Ivokana showed additional side effects that could be serious. These side effects include
- Raised LDL (bad) cholesterol levels
- Vaginal yeast infections
- Urinary tract infections
- Elevated stroke risk
- Small heart attack risk
The significance of the side effect findings remains unclear, according to the FDA. The label of Invokana includes no warnings about heart attack or stroke risk. However, the FDA requires Johnson & Johnson to conduct five post-marketing studies and one clinical trial to conclusively determine if the drug does increase risk of stroke and heart attack.
Despite possible serious side effects, Invokana is available to consumers at a wholesale price of $8.77 per tablet. Johnson & Johnson states the price of Invokana is competitive with other diabetic medications.
Read more about the FDA approval of Invokana here.Comments (4)
- Help Make Generic Drug Manufacturers Accountable for Safety by Signing Take Justice Back Petition
- Hawaii Dept. of Health Links Diet Supplement OxyElite Pro to Liver Failure
- FDA Issues Black Box Warning on Two Cancer Drugs
- FDA Strengthens Warning on Lariam, Anti-Malaria Drug
- Study Links Calcium-Channel Blockers to Breast Cancer
- C.R. Bard Reaches Settlement in Second Lawsuit Trial Over its Transvaginal Mesh Product
- Roche Halts Development of New Diabetes Drug Due to Safety Concerns
- Advertising Nets Lipitor Better Sales Despite Dangerous Side Effects, Generic Competition
- FDA To Revisit Rule Blocking Lawsuits Against Generic Drug Makers
- Study Finds Januvia May Damage Pancreas
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