Nab speaks with HuffPo on the Connection Between Drug Forumulations and the Recent HIV Outbreak in Indiana
A recent outbreak of HIV in Indiana has shed light on the changing risks associated with illicit use of prescription drugs. Since late-2014, there have been 27 confirmed and 10 suspected cases of HIV infection attributed to injection of Opana, an opioid pain reliever marketed by Endo Pharmaceuticals. So how does this latest outbreak relate to the 2012 change of Opana’s formulation? Read our very own Nab Dasgupta’s comments on the case from a harm reduction perspective, along with words from other experts working in the field: Prescription Drug Abuse Linked To Indiana HIV Outbreak Read More
Website Lets Buyers, Sellers Share Drug Prices Online
StreetRx was featured on CBS Boston’s evening news last night in a story that highlighted how and why we track street prices of prescription drugs. Reporter Jim Armstrong described how the site was used to gather and share information, and how various members of the community benefit from a tool that sheds light on an otherwise opaque black market. Epidemico co-founder Clark Freifeld described how a combination of intuitive interfaces and crowdsourced feedback help us to learn about the economics of diverted pharmaceuticals, and Analyst Michael Gilbert discussed the value of direct and anonymous engagement with people who buy and sell those drugs on the street. Read More
StreetRx at the 2014 National Harm Reduction Conference
Mike and Nab recently joined a panel at the 2014 Nation Harm Reduction Conference in Baltimore, MD. Mike presented an intro to streetRx, focusing on its value as a ‘magnet content’ tool to share health and wellness information with people who use drugs. Read More
Harm Reduction, Magnet Content, and the Future of Health Promotion
Meeting people who use drugs ‘where they’re at’ is a core principle in the practice of harm reduction. Programs are carefully designed to be culturally competent, respectful of dignity, and non-judgmental in their effort to reduce harms associated with drug use. One of the challenges facing the harm reduction community is that health promotion information often comes in the form of media that are health-specific, and that rely upon their audience’s interest and engagement in health-seeking behaviors. Read More
“Yang” food no longer safe? : Major U.S. food producers are headlining in China’s latest food safety turmoil
Chinese food manufactures have been involved in a series of food safety incidents in the past few years, including the Melamine-tainted infant formula case in 2008 and the alleged production of toxic chicken jerky treats that injured or killed thousands of American pets. As a result, people are turning to “Yang” food, a Chinese term for foreign-brand food. Despite much higher prices than their Chinese counterparts, these food products are increasingly welcomed in Chinese families due to their good safety record. But what happened this past month might have changed Chinese people’s idea about “Yang” food. Read More
DTC Television ads and drug adverse event reporting: Does one lead to another?
Do television ads for prescription drugs affect people’s behavior in reporting adverse events? Do they ultimately stimulate, suppress or not affect the reporting behavior?
To answer this question, we have designed a quick and dirty experiment using our MedWatcher Social platform. Read More
The revolution will not be televised, but it may be posted on Twitter and Facebook
We are pleased to announce that our social media monitoring and analytics platform, MedWatcher Social, has been featured in an article on The Pink Sheet, “Adverse Events In Social Media: FDA Expects Signal Detection ‘Revolution.’”
Sarah Karlin describes how the FDA expects to expand on its traditional adverse event collection process by utilizing data from social media spaces like Facebook and Twitter to assist in post-market surveillance. Karlin also discusses how our team at Epidemico has worked with the FDA to provide them with the necessary technology for such surveillance using our MedWatcher Social platform.
Our capabilities with MedWatcher Social are best illustrated by Karlin’s coverage of a brief study that one of our co-founders, Nabarun Dasgupta, recently conducted for a presentation at the Drug Information Association (DIA). Nabarun examined MedWatcher Social data for 15 drugs that had been captured over six weeks. Out of 27,200 drug mentions from Facebook and Twitter, 47 posts described events that resembled adverse events (which we call “proto-AEs”); the majority of those posts (89%) described events related to Tecfidera (dimethyl fumarate), Biogen Idec’s multiple scerlosis drug. Nabarun then compared the social media data to the clinical trial data found in the Tecfidera drug label. The results were impressive:
As illustrated in the graph, MedWatcher Social captured proto-AEs that were not observed previously during Tecfidera’s pivotal trial. This has significant implications for the value of social media platforms in evaluating the safety of an approved product based on what patients are saying — and the fact that the rank-order of proto-AEs reported in social media correlates to that of those reported during the pivotal trial suggests that what these patients are saying can be quite valid indeed.
While there are still many limitations to social media (which Karlin’s article outlines), the potential for the FDA to use it as a barometer for early safety signals is tremendous.
The original article can be found on The Pink Sheet.
To learn more about our MedWatcher Social tool, please click here.
FDA post-market evaluation results, 2013
All drugs, devices and vaccines must undergo several phases of clinical trials before they are approved and brought to market; the process of evaluating a medical product’s safety profile, however, does not stop at approval. The FDA conducts what are called post-market evaluations to determine if any unforeseen side effects occur once a drug has been used by the general population either 18 months after approval or by the time the the drug has been used by 10,000 individuals (whichever is later).
The data for several drugs were evaluated in 2013. While many passed muster with no new safety concerns, a few did not. These are the drugs that require ongoing surveillance or regulatory action, as determined by the FDA, Jan 2013-Dec 2013:
| Drug | Reported AEs | FDA Action |
|---|---|---|
| Brilinta (ticagrelor) | neutropenia, thrombocytopenia, pancytopenia, clinical gout | continuing to evaluate to determine if regulatory action is required |
| Caldolor (ibuprofen) injection | infusion-site reactions | continuing to evaluate to determine if regulatory action is required |
| Edarbi (azilsartan kamedoxomil) | ngioedema, anaphylaxis | continuing to evaluate to determine if regulatory action is required |
| Edarbyclor (azilsartan kamedoxomil and chlorthalidone) | decreased blood sodium/hyponatreemia, angioedemia | continuing to evaluate to determine if regulatory action is required |
| Gralise (gabapentin) | anaphylactic reactions | continuing to evaluate to determine if regulatory action is required |
| Heparin sodium injection, USP | heparin-induced hyperkalemia | continuing to evaluate to determine if regulatory action is required |
| Horizant (gabapentin encarbil) | hallucinations, abnormal dreams, hyperuricemia | continuing to evaluate to determine if regulatory action is required |
| Nucynta ER (tapentadol XR) | hypertension, extrapyramidal syndrome, renal insufficiency | continuing to evaluate to determine if regulatory action is required |
| Tradjenta (linagliptin) | pancreatitis, hypersensitivity reaction, medication errors involving excessive dosing | label updated in June 2013 to include information about pancreatitis, including fatal pancreatitis |
| Treanda (bendamustine hydrochloride) | pneumocystis pneumonia | continuing to evaluate to determine if regulatory action is required |
| Vibativ (telavancin) | anaphylaxis, incorrect product reconstitution | label updated in June 2013 to include information about anaphylaxis. |
| Xarelto (rivaroxaban) | thrombocytopenia, venous thromboembolic events | continuing to evaluate to determine if regulatory action is required |
| Zytiga (abiraterone) | pneumonitis, pulmonary embolism, rhabdomyolysis | continuing to evaluate to determine if regulatory action is required |
ICYMI: FDA’s biggest announcements from 2013
January – lowers recommended dose for certain sleep drugs containing zolpidem (e.g. Ambien, Zolpimist); approves 3 new drug txs for type 2 diabetes (Nesina, Kazano, Oseni); approves new orphan drug Kynamro to treat inherited cholesterol disorder
February – approves first retinal implant for adults with rare genetic eye disease; approves new treatment Kadcyla for late-stage breast cancer
March – approves Invokana to treat type 2 diabetes, Tecfidera new tx for MS; TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients
April – approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older; approves Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults; approves Diclegis for pregnant women experiencing nausea and vomiting
May – approves Simponi to treat ulcerative colitis; approves new drug for advanced prostate cancer
June – approves the first non-hormonal treatment for hot flashes associated with menopause; approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential
July – announces a voluntary recall of Nova Max Blood Glucose Test Strips; approves new treatment for a type of late-stage lung cancer
August – approves Tivicay (dolutegravir); a new drug to treat HIV-1 infection and the first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies
September – approves Brintellix for Major depressive disorder and Abraxane for late-stage pancreatic cancer
October – approves Opsumit for pulmonary arterial hypertension and Adempas for pulmonary hypertension; hydrocodone product Zohydro ER
November – removes restrictions on prescribing diabetes drug Avandia; approves a medical device to treat epilepsy; new treatment Olysio for hep C virus and an adjudicated vaccine for bird flu H5N1
December – approves generic versions of Cymbalta; approves Sovaldi for chronic hep C; first treatment for Peyronie’s disease; addresses antibacterial soaps
Why Report via MedWatcher?
When you report your side effects to MedWatcher, you’re not only formally documenting your experience with the FDA but you’re also letting other MedWatcher users know, anonymously. We work in real-time, sharing adverse event reports with the MedWatcher community as soon as we can format them.
Your knowledge of side effects could provide valuable information to other users who may be researching a new prescription or wondering if a side effect they’re experiencing themselves is common or not. When you report to MedWatcher, you’re also reporting to the MedWatcher community.